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INTRODUCTION
Inhalation therapy targets drug delivery to the lungs and allows a distinct therapeutic advantage over systemic therapy with the use of smaller drug dose, a more rapid onset of therapeutic action and decreased side effects. For these reasons, inhalation therapy is recommended and most commonly used mode of drug delivery in bronchial asthma and COPD. One of the important reasons for suboptimal control of asthma and COPD is the insufficient delivery of inhaled drug due to either wrong selection of inhalation device or incorrect inhalation technique. 1.Poor handling and wrong inhalation
technique are associated with decreased medication delivery
and poor disease control 2-4. Various types of inhaler devices are currently being used in the management of COPD and BA which includes Metered Dose Inhaler (MDI), Dry Powder Inhaler (DPI), Metered Dose Inhaler with
Spacer (MDI with Spacer), Breath actuated Metered Dose
Inhaler (baMDI) and Nebulizer.

DPIs are devices which require adequate inspiratory flow rate for optimal deposition of drugs in lungs.These devices are easier to use since they overcome the hand lung coordination required in MDI.

The hand lung coordination problem encountered while using MDIs can be overcome by using MDI with spacer. Spacers have various advantages as it assists in pMDI use by reducing the hand lung coordination , by increasing the drug delivery to lungs and simultaneously reducing oropharyngeal deposition and systemic absorption.

Bronchial asthma is a heterogeneous disease, usually characterizedby chronic airway inflammation. It is defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity together with variable expiratory airflow limitation.5Bronchial asthma is estimated to affect some 300 million people worldwide and accounts for about one per cent of all disability-adjusted life years lost.5Distinguishing asthma from COPD can be problematic particularly in smokers and older adults. COPD is a common , preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases.6Chronic obstructive pulmonary disease claimed 3.0 million lives in 2016.7

Now a days, asthma and COPD (Chronic obstructive Pulmonary disease), are mainly treated by inhaled therapy 8. This practice became popular many years after the introduction of atropine and adrenaline, as bronchodilators 9, only when efficient nebulizer ampoules and inhalers 10 finally became available. Three types of dispensers for lung deposition of drugs: A) nebulizers, B) pressurized inhalers and C) the dry powder inhalers; many models of each type are available. In patients with asthma or COPD who show poor inhaler technique with a pMDI, the addition of a large-volume spacer and education from a health professional (rather than simply changing inhalers) might be the best initial strategy for improving inhaler technique 11
Over the decades, inhalation therapy has become the
backbone in the treatment of these disorders, althoughnew inhalers have been designed to improve ease of use, significant rates of incorrect use have been reportedamong COPD and bronchial asthma patients, even amongregular adult users.12
About 90% ofCOPD and asthma patients are using standard pressurised metered dose inhalers (pMDIs)or dry-powder inhalers (DPIs) with incorrect technique 13
With short-acting ?2 agonists (relievers), poor inhaler technique results in loss of bronchodilator effect 14,15. The patients who use standard pMDIs without a spacer, failure to coordinate inspiration with actuation ,results in reduced lung deposition of medication 16.
Education about medications occurs mostly during doctor consultations at the time of prescribing, and yet evidence points to the passivity of the patient and a low level of information exchange during such consultations 17. Incorrect use of pMDIs for inhaled corticosteroids (ICS) has been associated with increased reliever use, increased use of emergency medical services, worsening asthma 18. Inefficient technique with DPIs may also lead to insufficient drug delivery and therefore insufficient lung deposition 19.

Therefore, it is necessary on the part of the physicians, nurses, and other health care providers, to understand the issues related to performance and correct use of these inhaler devices, and also to understand the difficulties faced by patients while using them.

However, only few previous studies have investigated the frequency and impact on asthma control due to poor knowledge regarding correct use of inhalers by patients or health care givers8.

The present study is being done to find out the usage of inhalation device and assessment of inhalation technique in bronchial asthma and COPD.We are undertaking this study in our institution with the following aims and objectives.

AIM AND OBJECTIVES:
To study the use of inhaler devices by the patients of Bronchial asthma and COPD according to standard steps and Errors committed in different steps of use.

REVIEW OF LITERATURE
Aerosols exist everywhere there is gas to breathe. From pollen and spores, to smoke and pollution, to man-made chemicals, the aerosol category includes any fine liquid or solid particles. A “medical aerosol” is any suspension of liquid or solid drug particles in a carrier gas.20 Respiratory system is evolved to have filtration and elimination systems that must be overcome or bypassed in the process of providing local delivery of medications to the lung. Methods for generating aerosols, formulating drugs, and administering medications effectively to the desired site of action constitute the science of aerosol drug delivery.

Inhalation devices are used for inhalation therapy worldwide for treatment of asthma and COPD. This is because of its proven efficacy, above any other class of asthma and COPD therapy and also its lower potential for systemic side effects compared to other drugs1. Various inhalation devices used for inhalation therapy are pressurized metered dose inhalers(pMDIs),dry powder inhalers (DPIs),spacers and nebulizers. The pMDI and DPI are medical aerosol delivery devices that combine a device with a specific formulation and dose of drug. Each actuation of the inhaler is associated with a single inspiration of the patient. These are typically single-patient-use devices dispensed from the pharmacy with a specific quantity of medication and disposed of when the medication has been depleted.
The correct inhalation technique , requiring hand lung coordination can be taught either by practical demonstration or by written instructions. Patients are commonly prescribed several types of inhalers with different instructions for operation. Confusion between device operation can result in suboptimal therapy. For example, pMDIs typically require slow inspiratory flow (<30 L/min)
with a breath-hold, while a DPI may require significantly high flows (30–90 L/min) based on their resistive properties to disperse a full dose. Patients may confuse which inspiratory flow to use with which device and may get much less drug from both devices. Therefore,
education and repetitive return demonstration is the key to proper inhaler use.21
pMDI :
Since its development by Dr. George Maison in 1955, the pMDI has been the most common aerosol generator prescribed for patients with asthma and COPD. This is because it is compact, portable, easy to use, and provides multi-dose convenience in a single device.21
The pMDI was designed and developed as a drug and device combination that delivers precise doses of specific drug formulations. Unlike nebulizers, drug preparation and handling is not required with pMDIs, and the internal components of pMDIs are difficult to contaminate.

Advantages and disadvantages of the pMDI21
Advantages Disadvantages
Portable, light, and compact Hand-breath coordination required
Multiple dose convenience Patient activation, proper inhalation pattern, and breath-hold required
Short treatment time Fixed drug concentrations
Reproducible emitted doses Reaction to propellants in some patients
No drug preparation required Foreign body aspiration from debris-filled
mouthpiece
Difficult to contaminate High oropharyngeal deposition.
Difficult to determine the canister without dose counter’

Types of pMDIs
There are three major types of pMDIs: conventional pMDIs, breath-actuated pMDIs, and soft-mist inhalers. Regardless of manufacturer or active ingredient, the basic components of the pMDI include the canister, propellants, drug formulary, metering valve, and actuator.

Basic components of the pMDI21
Canister Inert, able to withstand high internal pressures and utilize a
coating to prevent drug adherence
Propellants Liquefied compressed gases in which the drug is dissolved or
suspended
Drug Formulary Particulate suspensions or solutions in the presence of surfactants
or alcohol that allocate the drug dose and the specific particle size
Metering Valve Most critical component that is crimped onto the container and is
responsible for metering a reproducible volume or dose
Elastomeric valves for sealing and preventing drug loss or leakage
Actuator Frequently referred to as the “boot,” partially responsible for particle
size based on the length and diameter of the nozzle for the various
pMDIs (Each boot is unique to a specific pMDI/drug.)
Dose Counter This component provides a visual tracking of the number of doses
remaining in the pMDI

Figure 1. Standard components of pMDI22
How a Conventional pMDI works21

pMDI consists of a canister, the medication, the propellant/excipient, a metering valve, the mouthpiece, and actuator.42 The medication represents only 1–2% of the mixture emitted from the pMDI and is either suspended or dissolved in the propellant/excipient mixture. The propellant of the pMDI makes up 80% of the mixture. A surface-active agent, such as surfactant, is occasionally used in order to maintain suitable particle sizes produced in the aerosol plume by chlorofluorocarbon (CFC) pMDIs. These agents prevent aggregation of the drug particles and lubricate the metering valve. They also ensure that the drug is well suspended in the canister. The metering valve acts to prepare a pre-measured dose of medication along with the propellant. The volume of the metering valve changes from 25–100 ?L and provides 50 ?g to 5 mg of drug per actuation, depending on the drug formulation.

The conventional pMDI has a press-and-breathe design. Depressing the canister into the actuator releases the drug-propellant mixture, which then expands and vaporizes to convert the liquid medication into an aerosol. The initial vaporization of the propellant cools the aerosol suspension. The canister aligns the hole in the metering valve with the metering chamber when it is pressed down. Then, the high propellant vapor pressure forces a premeasured dose of medication out of this hole and through the actuator nozzle. Last, releasing the metering valve refills the chambers with another dose of the drug-propellant mixture. The two types of propellants used with pMDIs are CFCs and HFAs. Because of CFCs’ detrimental effect on the earth’s ozone layer and contributions to global warming, CFCs
were banned worldwide. As a replacement, HFAs were developed and incorporated into pMDIs. HFAs are pharmacologically inert and have similar characteristics to CFCs.

Breath-actuated pMDI
The Autohaler was the first flow-triggered breath-actuated pMDI. It was designed to eliminate the need for hand-held coordination during drug administration. Its mechanism is triggered by inhalation through a breathactuated nozzle, which provides an automatic response to the patient’s inspiratory effort. In order to cause drug release with the Autohaler, the lever on top of the device must be raised before use. Thereby, the vane of the device releases the spring, pushing the canister down and actuating the pMDI at the point when the patient’s inspiratory effort exceeds 30 L/min. If the patient has good
coordination with the conventional pMDI, the use of a breath-actuated pMDI may not improve drug delivery.23,24
Currently Available pMDI Formulations
Pressurized metered-dose inhalers are presently used to administer beta-2 agonists, anticholinergics, anticholinergic/beta-2 agonist combinations, corticosteroids, and antiasthmatic drugs.

Factors Affecting pMDI Performance and Drug Delivery
Most pMDIs are designed to deliver a drug dose of 100 ?m per actuation. Drug delivery with the pMDIs is approximately 10–20% of the nominal dose per actuation. The particle size of aerosols produced by the pMDIs is in the fine particle fraction range in which the aerodynamic diameter of aerosols is less than 5 ?m. Several
factors influence the pMDI performance and aerosol drug delivery. Understanding the effects of these factors will improve the efficacy of pMDIs when used for patients with pulmonary diseases. Therefore, both respiratory therapists and patients must actively control the following effects.

• Shaking the Canister: Not shaking a pMDI canister that has been standing overnight decreases total and respirable dose by 25% and 35%, respectively, because the drugs in pMDI formulations are usually separated from the propellants when standing.25
Therefore, pMDIs must be shaken before the first actuation after standing in order to refill the metering valve with adequately mixed suspension from the canister.26
• Storage Temperature: Outdoor use of pMDIs in very cold weather may significantly decrease aerosol drug delivery. For example, although dose delivery from CFC pMDIs decreased by 70% at 10ºC, it was constant with HFA pMDIs over the range of -20º to20ºC.24
• Nozzle Size and Cleanliness: The amount of medication delivered to the patient is dependent upon nozzle size, cleanliness, and lack of moisture. Actuator nozzle is pMDI specific, and the coordination of the nozzle with the medication will influence both inhaled dose and particle size. In general, there is an inverse relationship between the
inner diameter of the nozzle extension and the amount of drug delivered to the patient.27 A nozzle extension with an inner diameter ; 1 mm increases drug delivery.27 White and crusty residue due to crystallization of medication may influence drug delivery.

Therefore, the nozzle should be cleaned periodically.

• Timing of Actuation Intervals: The rapid actuation of more than two puffs with the pMDI may reduce drug delivery because of turbulence and the coalescence of particles.25 A pause between puffs may improve bronchodilation, especially during asthma
exacerbations with episodes of wheezing and poor control of symptoms.28 Although early research was mixed regarding the importance of a pause between the two actuations, recent literature suggests a pause of one minute between actuations for effective aerosol therapy.20,29,30
• Priming: Priming is releasing one or more sprays into the air. Initial and frequent priming of pMDIs is required in order to provide an adequate dose. The drug may be separated from the propellant and other ingredients in the canister and metering valve when the pMDI is new or has not been used for awhile. Because shaking the pMDI will mix the suspension in the canister but not the metering chamber, priming of the pMDI is required.21
Characteristics of the Patient: Aerosol deposition will be lower in infants and children due to differences in their anatomy and their physical and cognitive abilities.21
• Breathing Techniques: There are two primary techniques for using a pMDI without a spacer: the open-mouth technique and the closed-mouth technique. The manufacturers of pMDIs universally recommend the closed-mouth technique for using a pMDI.
Closed mouth technique: In this method, the mouthpiece of the boot is placed between the sealed lips of the patient during drug administration.
Open-mouth technique: some researchers and clinicians have advocated an open-mouth technique in an attempt to reduce oropharyngeal deposition and increase lung dose.31,32
When using the open-mouth technique, the inhaler is placed two finger widths away from the lips of an open mouth and aimed at the center of the opening of the mouth. Studies suggest that the open-mouth technique reduces unwanted oropharyngeal deposition by allowing aerosol plume more distance to slow down before reaching the back of the mouth and up to two-fold more drug deposition to the lung than with use of the closed-mouth technique.31,32 In contrast, other researchers suggest that the open-mouth technique does not offer any advantage over the closed-mouth technique,33,34 but that it does create additional hazards such as the aerosol plume being misdirected from the mouth and into the eye or elsewhere.35 Therefore, the best technique should be determined based on the patient’s physical abilities, coordination, and preference.
Drug-delivery Technique
Because different types of pMDIs are available on the market, the respiratory therapist should carefully review operation instructions prior to giving aerosol therapy and certainly prior to instructing patients in at-home use.

Techniques for pMDIs21
Open-mouth Technique: The patient should be instructed to:
1. Warm the pMDI canister to hand or body temperature.

2. Remove the mouthpiece cover and shake the pMDI thoroughly.

3. Prime the pMDI into the air if it is new or has not been used for several days.

4. Sit up straight or stand up.

5. Breathe all the way out.

6. Place the pMDI two finger widths away from their lips.

7. With mouth open and tongue flat (tip of tongue touching inside of their lower front teeth), tilt outlet of the pMDI so that it is pointed toward the upper back of the mouth.

8. Actuate the pMDI as she/he begins to breathe in slowly.

9. Breathe slowly and deeply through the mouth and hold their breath for 10 seconds. If she/he cannot hold their breath for 10 seconds, then for as long as possible.

10. Wait one minute if another puff of medicine is needed.

11. Repeat Steps 2–10 until the dosage prescribed by the physician is reached.

12. If taking a corticosteroid, she/he should rinse their mouth after the last puff of medicine, spit out the water, and not swallow it.

13. Replace the mouthpiece cover on the pMDI after each use.

Closed-mouth Technique: The patient should be instructed to:
1. Warm the pMDI canister to hand or body temperature.

2. Remove the mouthpiece cover and shake the inhaler thoroughly.

3. Prime the pMDI into the air if it is new or has not been used for several days.

4. Sit up straight or stand up.

5. Breathe all the way out.

6. Place the pMDI between their teeth; make sure that their tongue is flat under the mouthpiece
and does not block the pMDI.

7. Seal their lips.

8. Actuate the pMDI as they begin to breathe in slowly.

9. Hold their breath for 10 seconds. If they cannot hold their breath for 10 seconds, then for as long as possible.

10. Wait one minute if another puff of medicine is needed.

11. Repeat Steps 2–10 until the dosage prescribed by the patient’s physician is reached.

12. If taking a corticosteroid, she/he should rinse the mouth after the last puff of medicine, spit out the water and not swallow it.

13. Replace the mouthpiece cover on the pMDI after each use.

Dry Powder Inhalers (DPI)
Dry powder inhalers (DPI) consist of pharmacologically active powder as an aggregate of fine micronized particles in an inhalation chamber.

Figure 2: Commonly used dry powder inhaler.

These aggregates are converted into an aerosol by inspiratory airflow through the inhaler generated by the patient. This basic fact excludes the problem of coordination between the delivery of the drug and the initiation of inspiration.36 Lack of requirement of propellant is an advantage of DPIs over MDIs. The fraction of the drug delivered to the site of action by a DPI varies from 9% to 30% and varies among different commercially available products.37,38
Advantages of DPI:39
Small and portable.

Short preparation and administration times.

Breath actuation: No need for hand breathing coordination.

No inspiratory hold or head tilt needed.

No CFC propellants (environment friendly).

No cold Freon effect to cause bronchoconstriction or inhibit full inspiration.

Simple determination of remaining drug doses.

Built in dose counter.

Disadvantages of DPI:39
Only a limited range of drugs is available to date.

Patients are not as aware for the dose inhaled as an MDI and may distrust delivery.

Moderate to high inspiratory flow rates are needed for powder dispersion.

Relatively high oropharyngeal deposition and impaction can occur.

A device such as Aerolizer is a single-dose device and muct be loaded before use.

Vulnerable to humidity.

In a DPI, the aerosol needs to be generated from the powder formulation by patient’s own effort. For achieving this, a high turbulence is needed to break the large agglomerates of the drug into smaller, finer and inhalable particles.36
Turbulence is generated by creating resistance to air flow in the DPI device and the effort required to generate adequate flow rates is dependent on the extent of resistance. Whereas the flow rates required to be generated vary among various available DPIs, a flow rate of 60-90 L/min is generally required.40 This makes the use of DPI unsuitable for elderly as well as younger pediatric patients and those with severe bronchospasm.

High humidity and rapid changes in temperature may affect de-aggregation of the drug particles and reduce the fraction of the drug being delivered.41,42
Types of DPIs
Currently, DPIs can be classified into three categories based on the design of their dose containers, i.e., single-dose DPIs, multiple unit-dose DPIs, and multiple-dose DPIs.21
While the single-dose DPIs have individually wrapped capsules that contain a singledose of medication, multiple unit-dose DPIs disperse individual doses that are premetered into blisters of medication by the manufacturer. The third type, the multiple-dose DPI, either measures the dose from a powder reservoir or uses blister strips prepared by the manufacturers to deliver repeated doses. Regardless of the type of DPI, they all have the same essential components incorporated with the inhaler. They all have a drug holder, an air inlet, an agglomeration compartment, and a mouthpiece.

Figure3: Currently available dry-powder aerosol formulations in categorized by design features
Steps for Ideal Use of DPI36
1. Check that the device is clean and the mouthpiece free of obstruction.

2. Load a dose into the device as directed (if single dose device).

3. Hold the inhaler level with the mouthpiece and facing down.

4. Tilt your head back slightly, and beathe out slowly and completely without straining or breathing into the device (moisture from breath can clog the inhaler valve).

5. Place teeth over the mouthpiece and seal lips around it making sure not to block the device outlet with tongue.

6. Breathe in quickly and deeply (over two to three seconds) through the mouth to activate the flow of medication.

7. Remove the device from the mouth. Hold breath for 10 seconds (or as long as is comfortable), and then breathe out slowly against pursed lips. This step is very important. It allows the medication to
get deeply into the lungs.

Valved Holding Chambers/Spacers
To overcome the major problem related to coordination, a valved holding chamber may be used as an adjunct to the MDI.

Figure 4: Metered dose inhaler with spacer.

Advantages:36
Useful for old patients and those who are unable to hold breath.
Improved coordination with the inspiratory flow of the patient.

When an MDI is used with spacer devices, reduction occurs in the overall particle size of the inhaled aerosol, as larger particles tend to stick to the chamber walls/valves.
This also leads to a reduction in particle velocity leading to decreased upper airway deposition.
It should be explained to the patient that the aerosol must be inhaled immediately after the MDI is discharged into the chamber and only a single actuation should be discharged into the chamber for each inhalation. Following this, the patient should be instructed to breath in and out for a few breaths before actuating another discharge of MDI. The reduced oropharyngeal deposition associated with the use of a spacer chamber is an advantage when using corticosteroid MDIs as the local adverse effects are then much less likely to occur.
In spite of all these advantages, it has been shown that no extra benefit in terms of delivery is achieved by using a spacer device by the patients who follow the correct technique with MDI alone.37

Figure 5: Metered dose inhaler plus spacer showing good
seal with lips around mouthpiece.

Disadvantages: 36
Holding chambers are also not totally free of problems. Electrostatic charge develops on the inside of the chamber due to regular washing and drying and affects delivery of larger particles. Patients should be instructed to dry the chamber using a non-static cloth or to let it air dry.
Another drawback of using the holding chamber is that the new HFA based MDI have not been evaluated with the presently available chambers. Because of the differences in the physical characteristics of the particles generated by HFA based MDI, drug delivered to the patient may be different.

A study conducted by Jolly,et al at AIIMS for comparison of practical demonstration with written instructions for teaching inhalation technique showed a significant difference in the overall improvement achieved in the practical demonstration group compared with the written instruction group43.

DPIs are devices which require adequate inspiratory flow rate for optimal deposition of drugs in lungs.These devices are easier to use since they overcome the hand lung coordination required in MDI.
A study done by NCBI shows errors done by subjects using DPI’s are less than those using pMDI.Out of total 300 enrolled patients, 247 (82.3%) made at least one error. Maximum errors observed in subjects using MDI (94.3%), followed by DPI (82.3%), MDI with spacer (78%) while nebulizer users (70%) made least number of errors.44
The hand lung coordination problem encountered while using MDIs can be overcome by using MDI with spacer. Spacers have various advantages as it assists in pMDI use by reducing the hand lung coordination , by increasing the drug delivery to lungs and simultaneously reducing oropharyngeal deposition and systemic absorption.

In a study conducted by Alotaibi, et al it was concluded that when MDI inhalers are to be prescribed it is important to stress on using MDI with spacer or valve holding chamber to improve inhalation technique and to reduce errors thereby improving lung deposition of the drug required.45
Another study by Ganguly ,et al was done for examining the frequency of proper use of inhalation devices and influence of age and training on it by healthcare professionals. It showed among study population, 83.81% were trained by healthcare professionals (doctors, nurse, pharmacists, paramedical or representatives of pharmaceutical companies) and 16.19% are trained by general people. Only 6% among the MDI users (n=50),16.12% among the DPI users, 20.8%, among MDI with spacer users could use inhalers correctly. There was no difference found in regard of frequency of errors committed in taking different devices according to patient’s socioeconomic, educational background and trainer46
Patients using inhalation devices need to educated properly by practical demonstration and the same requires to be assessed frequently to ensure adequate drug delivery. In a study conducted by Micallef, et al shows that despite the fact that it is a well-known that appropriate drug delivery is key to controlling asthma and COPD, patients still tend to have poor pMDI technique hence the need for patient education with repeated assessment of the technique in follow-up clinics and prior to discharge. A total of 174 patients, 118 (67.4%) of which are asthmatics while 56 (32%) are COPD patients, were involved. A total score of 8 was achieved by 21 of the asthma patients and 3 of the COPD patients. 154 (88%) of all the patients owned a LVS but only 100 (57.5%) of all the patients used the LVS with pMDI regularly.47

In a study by Sehajpal R et al it was found that only 21% of the patients were able to perform inhalation technique correctly, and a total of 67 patients (78.82%) performed at least one step incorrectly. In our study, the step at which maximum number of patients patients committed mistake was exhalation (65.88%)  followed by breath holding (45.88%). Multiple actuations were seen in 43.53% of the patients. It was also found that patients who had been using the device for longer duration performed the technique correctly (P = 0.002). No significant correlation could be drawn between age, sex, education level, area of residence, and the correctness of the inhalation technique.48

In a study by Rootmensen et al, it was seen that overall, 40% of the patients made at least one essential mistake in their inhalation technique. Patients who never received inhalation instruction and patients who used more than one inhaler device made significantly more errors (odds ratio both 2.2). Comparison between devices showed that a correct inhalation technique most likely occurred with the use of prefilled dry powder devices.49
However very less data are available on how health care workers (HCW’s) use inhalers. As it is, the HCW who will eventually teach the patients the correct use of inhalers, it is important to know whether they themselves have adequate knowledge of the same.
In a study by Mullerpattan JB et al , use of pressured metered dose inhaler (pMDI) technique of adult patients with asthma as well as their HCW’s (doctors and nurse) in the hospital were evaluated. They found that techniques of 141 patients and 100 HCW’s (55 nurses and 45 doctors) were analyzed. The average technique score among patients ranged from 0 to 10 with a mean of 4.65 ± 2.00.

The combined score for health workers ranged from 3 to 9 with a mean of 5.45 ± 1.47. Doctors had a higher score of 6.35 ± 1.33 as opposed to the nurses’ score of 4.70 ± 1.13 (P < 0.05). There was no significant difference between scores of nurses and patients
(P > 0.05)50

In a study by Pothirat et al total of 103 COPD patients (mean age 71.2±9.2 years, males 64.1%, low education level 82.5%, and percent predicted forced expiratory volume in 1 second 51.9±22.5) were evaluated. Seventy-seven patients (74.8%) performed at least one step incorrectly. Patients using the Handihaler had the lowest compliance failure (42.5%), and the odds ratio for failure with the other devices compared with the Handihaler were 4.6 (95% confidence interval CI 1.8–11.8) for the pMDI, 3.1 (95% CI 1.2–8.2) for the pMDI with a spacer, and 2.4 (95% CI 1.1–5.2) for the Accuhaler. Low education level was the single most important factor related to incorrect technique (adjusted odds ratio 4.1, 95% CI 1.2–13.4, P=0.022). Formal training resulted in a statistically significant decrease in percentage of incorrect techniques for all devices and for the pMDI (59.4% vs 48.6%, P,0.001; 72.4% vs 48.3%, P=0.039, respectively).51

In a study by Dudvarski Ilic et al a total of 312 patients with asthma or COPD who used dry powder Turbuhaler were enrolled.
Significant improvement in inhalation technique was achieved after the third visit compared to the first one, as measured by the seven-step inhaler usage score (5.94 and 6.82, respectively; P,0.001). Improvement of disease control significantly increased from visit 1 to visit 2 (53.9% and 74.5%, respectively; P,0.001) and from visit 2 to visit 3 (74.5% and 77%, respectively; P,0.001). Patients’ subjective assessment of symptoms and quality of life significantly improved from visit 1 to visit 3 (P,0.001).52
4. MATERIALS AND METHODS:
Study Design: An observational cross-sectional Study
Place of study: Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune-411011
Period of study: July, 2016 to September, 2018
Institute Ethics committee clearance will be obtained before the start of study.

Sample Size: 100 cases
Assuming that 82% of inhalation device users commits at least 1 error with acceptable error of 8.2% on either side at a confidence level of 95%,the sample size works up to 85.Adding 15% the sample size comes around 100.

Statistical package- WinPepi

Age group and gender:
1. Male and female asthmatic patients more than 12 years of age on inhalation therapy
2. Male and female patients of COPD with age group of 40-70 years
Inclusion Criteria:
1.Patients with bronchial asthma age group more than 12 years of age
2.Patients with COPD with age group of 40-70 years on inhalation therapy
4.8 Exclusion Criteria:
1.Uncontrolled asthma
2.Acute exacerbation of COPD
3. Patients of bronchial asthma and COPD not on inhalation therapy
4. Patient not willing for demonstration inhalation technique
5. Patients using multiple devices.

Inhalers :
1.pMDI 4.DPI(Single dose)
2.pMDI with Spacers 5.DPI(Mutli Dose-Turbohaler)
3. Breadth Actuated pMDI(Autohaler) 6.DPI(Multi Dose-Accuhaler)
Method of study :
The study will include 100 outdoor and indoor patients of bronchial asthma and COPD. The diagnosis of bronchial asthma a will be confirmed by spirometry as per GINA(Global Initiative for Asthma ) guidelines. The diagnosis of COPD will be confirmed as per GOLD (Global Initiative for Chronic Obstructive lung Disease)guidelines. Demographic details, duration of bronchial asthma or COPD, type of inhalation device used, duration of usage of device of prescribing doctor, method of teaching the inhalation technique by doctor, assessment of various steps of inhalation technique, score against each correct step and assessment of control of disease will be assumed as per attached pro forma.

Statistical Analysis: Categorical variables were summarized as frequencies ; percentage and compared with Chi-Square test. The level of significance was set at 0.05. Data were analysed by Microsoft Excel 2010, MedCalc®Version14.8.1
RESULTS
1) Graph 1 – Bar diagram showing age and sex wise distribution of study sample.

Age (years)
Mean 55.80
Std. Error of Mean 1.581
Std. Deviation 15.81
Range 69
Minimum 16
Maximum 85

Mean age of study sample is 55.8 years with standard deviation of 15.81 years, with the highest 85 yrs and lowest 16 years. There were 71 (71%) males and 29 (29%) females in the study. 36 samples were from 61-75 years age group followed by 33 subjects in 46-60 years age group. No significant difference was observed between mean ages ofgender (p = 0.143).
2) Pie chart showing frequency distribution according diagnosis.

There were 51 (51%) bronchial asthma subjects among study samples, while 49 (49%) were having COPD.

3) Pie chart showing frequency distribution of study sample according to smoking history.

Above pie chart shows that, there history was smoking was present in more COPD Subjects (61%) than bronchial asthma subjects (31%). There was association between smoking history and diagnosis of subjects (p = 0.003).
4) Pie chart showing frequency distribution of study sample according to inhalation device used.

There were 32 (32%) study samples using DPI single dose inhalation device, followed by 31(31%) PMDI device. 30 (30%) were using PMDI with spacer while 7 (7%) were using DPI multi dose inhalation device.

5) Bar diagram showing method of instruction given touse inhalation device.

Above bar diagram shows that, demonstration was given in 53 (53%) subjects regarding inhalation technique, while in 47 (47%) subjects verbal instructions were given. Demonstration was required more in PMDI with spacer ; DPI multi dose, while verbal instructions required more in DPI single dose ; PMDI.

Mode of Instruction Incorrect Steps Correct Steps Marginal Row Total
Verbal 146 241 387
Demonstration 101 336 437
Marginal Column totals 247 577 824 (Grand Total)
Chi square test result shows that, less the mistake done when instruction mode was Demonstration than Verbal . There was significant difference between the modes of instruction and the result of steps of Inhalation(correct/incorrect), difference was statistically highly significant. P value is =0.000005.The result is significant at P ;0.05
6) Bar diagram showing distribution according to instructor of inhalation technique.

Above bar diagram shows that, Mostly chest physician (22%) was instructor in PMID with spacer while General Practioner (22%) was mostly the instructor in DPI single dose.
7) Bar diagram showing method of instruction given touse inhalation device.

Bar diagram shows that, Demonstration method of instruction was more preferred by chest physician than verbal method. While General Practioner and physicians preferred verbal method of instruction regarding use of device.

8) Table showing frequency of inhalation technique steps(Correct/Incorrect) with respect to instructor of inhalation devices in study samples.

Instructor Incorrect Steps Correct Steps Row Total
Chest Physician 58 256 314
General Practitioner 99 189 288
Physician 90 132 222
Column Total 247 577 824(Grand Total)
Chi square test result shows that, less the mistake was done by chest physician instructed subjects, than General Practitioner ; Physician. There was significant difference between instructor and result of steps of inhalation, difference was statistically highly significant. P value is ;0.00001.The result is significant at P;0.05
9) Table showing frequency of inhalation technique steps with respect to inhalation devices followed in study sample
Step Interpretation DPI Multi Dose DPI Single Dose PMDI PMDI with Spacer Total
Remove Cap/Cover Correct 7 32 31 30 100
Shake the Inhaler Correct 0 0 15 20 35
Not Correct 0 0 16 10 26
Not Included 7 32 0 0 39
Insert inhaler in spacer Correct 0 0 0 27 27
Not Correct 0 0 0 3 3
Not Included 7 32 31 0 70
Place of Capsule in chamber Correct 0 31 0 0 31
Not Correct 0 1 0 0 1
Not Included 7 0 31 30 68
Press the spike button Correct 0 28 0 0 28
Not Correct 0 4 0 0 4
Not Included 7 0 31 30 68
Load the drug by pressing lever/twisting grip around till click heard Correct 4 0 0 0 4
Not Correct 3 0 0 0 3
Not Included 0 32 31 30 94
Exhale before inhaling Correct 4 8 12 18 42
Not Correct 3 24 19 12 58
Place the mouthpiece between teeth without gap Correct 7 27 26 27 87
Not Correct 0 5 5 3 13
Breath in deeply after loading drug/Inhaler dose in the spacer Correct 5 20 0 17 42
Not Correct 2 12 0 13 27
Not Included 0 0 31 0 31
Breath in ; release 1 dose simultaneously by pressing canister Correct 0 0 8 0 8
Not Correct 0 0 23 0 23
Not Included 7 32 0 30 69
Breadth Hold Correct 4 6 15 14 39
Not Correct 3 26 16 16 61
Exhale in spacer, inhale ;Hold breath again Correct 0 0 0 20 20
Not Correct 0 0 0 10 10
Not Included 7 32 31 0 70
Remove the inhaler and Breath out Correct 7 29 26 30 92
Not Correct 0 3 5 0 8
Open to check leftover powder Correct 0 22 0 0 22
Not Correct 0 10 0 0 10
Not Included 7 0 31 30 68
Out of the 100 subjects,the maximum mistakes committed which was common for all the devices was that 61(61%) subjects had short breath hold after inhaling the drug from device,while 2nd most common mistake was 58 subjects (58%)did not exhale to residual volume before inhaling the drug.

In the PMDI devices with or without spacer ,32 subjects(52.45%) of subjects had short breadth hold while second most common error was not exhaling before inhaling in 31 subjects (50.81%).The third and a major mistake was that 26(42.62%)Subjects didn’t shake the inhaler before use.

In PMDI devices without spacer the major issue was of hand breadth coordination where 23 subjects (74.19%)committed error and did not have proper coordination.It was followed by short breadth hold and not shaking the inhaler where in both steps 16(51.61%) subjects committed mistakes.
In the PMDI with spacer ,16 subjects(53.33%) of subjects had short breadth hold while second most common error was unable to breathe in deeply from the spacer in 13subjects(43.33) and the third common error was not exhaling before inhaling in 12 subjects (40%).

In DPI devices the maximum mistakes committed which was that 29(74.35%) subjects had short breath hold after inhaling the drug from device, while 2nd most common mistake was 27subjects (64.10%)did not exhale to residual volume before inhaling the drug.

Discussion
This is a hospital-based study that was conducted on 100 patients attending the Department of Respiratory Medicine in a tertiary-care hospital, Pune, Maharashtra to assess the correctness of inhaler technique among its users.
1. Age and Sex: In our study Mean age of study sample is 55.8 years with standard deviation of 15.81 years, with the highest 85 yrs and lowest 16 years. There were 71 (71%) males and 29 (29%) females in the study.

When we compare our study with the study by Saxena et al53 conducted on a purposive (nonrandom) sample of patients attending the Department of TB and Chest Diseases, FH Medical College and Hospital, Uttar Pradesh it has been seen that in their study most of the study subjects were male subjects (70%). The mean age of the study subjects was found to be 51 ± 14 years which correlates with our study. We can also correlate our study with the study by Arora et al,58 done in Lala Ram Sarup Institute of Tuberculosis and Respiratory Diseases, New Delhi, India where the male female ratio of the enrolled participants was 4:1 with a mean age of 42.59 years (SD ±14) which is similar to our study.
2. Diagnosis: Global Initiative for Chronic Obstructive Lung Disease and Global Initiative for Asthma reported 60% uncontrolled COPD and asthma patients worldwide.5,6 In our study, there were 51 (51%) bronchial asthma subjects among study samples, while 49 (49%) were having COPD. But there is no significant difference in the prevalence (p=0.8423) of both the diseases. In the study by Saxena et al53 62.8% (59 of 94) patients were experiencing COPD, while 37.2% (35 of 94) were patients of bronchial asthma.

In another study by Arora et al,58 out of the 300 subjects, 188 (62.7%) were known/diagnosed cases of COPD and 112 (37.2%) were Bronchial Asthma. In the above mentioned studies done in North India both showed more cases of COPD than bronchial asthma while in our area bronchial asthma prevalence is more than COPD however the difference is not significant.

3. Association with smoking: The World Health Organization and the Global Alliance against Chronic Respiratory Diseases identified the most important risk factors for respiratory diseases as: tobacco smoke, indoor and outdoor air pollution, allergens, occupational agents, diet and nutrition, and pulmonary infections.59,60 In our study the history of smoking was present more in COPD Subjects (61%) than bronchial asthma subjects (31%). There was association between smoking history and diagnosis of subjects (p = 0.003). However we have not distributed the subjects into male and female smokers and ex smokers and smokers.

In the study by Ganguly ,et al46 among male subjects 38.1% were smoker, 36.4% ex-smokers & 25.5% non-smoker. No female subject has smoking habit. They have not shown the association between smoking history and diagnosis (COPD/Bronchial asthma). In another study by Sehajpal R et al48 42.6% were ex-smokers and 15.4% were smokers. They also had not shown any association of smoking with the diagnosis.

4. Distribution of subjects according to use of inhalation devices: In our study there were 32 (32%) study samples using DPI single dose inhalation device, followed by 31(31%) PMDI device, 30 (30%) were using PMDI with spacer while 7 (7%) were using DPI multi dose inhalation device. In another study by Arora et al,58 DPI users (n = 130, 43.3%) were the highest among the enrolled population followed by MDI (n = 70, 23.3%), MDI with Spacer (n = 50, 16.7%) and Domiciliary Nebulizer (n Z 50, 16.7%) users which correlates to our study. In another study by Pothirat et al51 Accuhaler users (n=83, 41.5%) were the highest among the enrolled population followed by pMDI users (n=44, 22.0%), Handihaler users (n=40, 20.0%), and pMDI with spacer users (n=33, 16.5%).

5. Instructor: In our study 100% of the patients were educated by doctors about the use of inhalation devices. Mostly Chest physician (22%) was instructor in PMID with spacer while General Practitioner (22%) was mostly the instructor in DPI single dose. Gupta Vitull et al. 61 found that 71.5% patients were self educated to learn the inhaler technique, 11.6% patients were educated by pharmacist, 10.7% by a hospital staff and only 6.2% patients were actually educated by a doctor. On the other hand, a study by Melani S et al. 62 showed doctors to be the most common source of instruction for inhalation technique (58%), followed by hospital staff (15%) and pharmacists (5%).This difference in educator of inhalation method may be ascribed to the fact that the hospital settings were different for different studies in terms of their functioning, and the present study participants had access to a special inhaler technique training center within the hospital which might had contributed to a higher number of patients being trained by the hospital staff and the doctors.

6. Verbal vs. Demonstration: The present study showed that demonstration method of instruction was more preferred by chest physician than verbal method. While General Practitioner and physicians preferred verbal method of instruction regarding use of device and it was seen that less the mistake done when instruction mode was demonstration than Verbal. There was significant difference between the modes of instruction and the result of steps of inhalation (correct/incorrect), difference was statistically highly significant. P value is <0.00001. This can be compared with the study by Pothirat et al51 where a significant increase in the percentage of improvement in inhalation technique was observed after face-to-face demonstrations and training.

7. Nature of error observed: In the present study it was observed that
out of the 100 subjects, the maximum mistakes committed which was common for all the devices was that 61(61%) subjects had short breath hold after inhaling the drug from device, while 2nd most common mistake was 58 subjects (58%)did not exhale to residual volume before inhaling the drug.

In the PMDI devices with or without spacer ,32 subjects(52.45%) of subjects had short breadth hold while second most common error was not exhaling before inhaling in 31 subjects (50.81%).The third and a major mistake was that 26(42.62%)Subjects didn’t shake the inhaler before use.

This findings can be correlated with the study by Arora et al,58 where most common errors made by the MDI users were “No/Short Breath hold” (45.71%), “Not exhaling to residual volume” (40%). In a recent study from Trivandrum,63 authors found that the major incorrect steps were, not exhaling properly before inhalation (62%), not holding breath correctly (57%), not correctly shaking the inhaler (55%), and not inhaling correctly (17%) for pMDI. In another study by Pothirat et al51 for the pMDI, the steps “breathe out gently to residual volume” and “shake inhaler thoroughly” were most frequently performed incorrectly. On the other hand in a study by Sehajpal R et al48the step at which maximum number of patients committed mistake was exhalation (65.88%) followed by breath holding (45.88%).
But in our study when we consider the PMDI devices without spacer the major issue was of hand breadth coordination where 23 subjects (74.19%) committed error and did not have proper co-ordination. It was followed by short breadth hold and not shaking the inhaler where in both steps 16(51.61%) subjects committed mistakes. Pothirat et al51 has seen that for the pMDI with spacer, the step “breathe in and out through mouthpiece at least three times” was most frequently performed incorrectly.
In our study in DPI devices the maximum mistakes committed which was that 29(74.35%) subjects had short breath hold after inhaling the drug from device, while 2nd most common mistake was 27subjects (64.10%)did not exhale to residual volume before inhaling the drug. Pothirat et al51 has seen that for the Accuhaler, the steps “breathe out gently to residual volume” and “inhale forcefully and deeply” were most frequently performed incorrectly. For the Handihaler, the step “hold breath for at least 10 seconds” was most frequently performed incorrectly. In a study by Arora et al,58 DPI users had “Insufficient acceleration (52.31%), “Not inhaling deeply enough (36.92%)” and “Poor seal around mouth piece (29.23%). In another study by Saxena et al53 the most crucial steps in case of DPI which most of the subjects were found to be performing incorrectly were found to be ‘forceful inhalation through the mouth’ (71.7%), followed by ‘slow exhalation (70.2%), followed by ‘breath holding after inhalation’ (69.1%) and ‘continuing to inhale until lungs were full’ (44.7%).

There are various factors which can influence the patient’s adaptation to the inhalation technique specially the type of instructor who taught the technique which affects the correctness of technique at the preliminary level. It could be due to lack of reinforcement of the technique and periodic observation in subsequent visits that could have ensured that patients maintained adequate technique or it could be deficits in technique of the physicians themselves that could lead them to often choose to not to instruct the patient. In our study, it was seen that less the mistake done when instruction mode was demonstration than Verbal. There was significant difference between the modes of instructions (Verbal vs. Demonstration). So simply asking the patient whether they are using an inhaler properly is not sufficient. As proficiency in good technique tends to decrease over time and patient might introduce errors unknowingly hence repetitive education as well as demonstration is very much necessary.

Conclusion
It was observed that majority of patients were unable to use their inhalers correctly; thus, proper training at each visit should be carried out to get maximum benefit from inhalers.

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