Asthma is defined as chronic inflammatory disease of the airway which involves recurrent episodes of shortness of breath, chest tightness, wheezing, and coughing in response to stimuli like allergens, medications, stress, and occupational irritants. This disease affects about 300 million people globally, and its prevalence rises by 50% every ten years.^[1] Asthma is mainly treated with inhaled medications in several forms, primarily including   Dry Powder Inhalers (DPI), Metered-Dose Inhalers (MDI) and Soft Mist Inhalers (SMI). Easy-to-use and the ease with which a medical practitioner can instruct a patient in the proper inhalation technique should be factors in the selection of an inhaler when a patient is prescribed an inhaled medication.^[2]

Noncompliance with inhaled pharmaceuticals results in suboptimal asthma control, escalated healthcare utilization and costs, and decreased health-related quality of life. ^[3] Improper inhaler usage is frequently linked with poor adherence. It is imperative to provide instruction for even the simplest of devices. The most effectual training method to teach the inhaler technique is verbal instruction combined with a physical demonstration.^[4] With their current inhalers, only 46–59% of asthma patients use an effective inhalation technique.^[2]A precise inhaler technique is of utmost importance for the optimum delivery of drugs to the lungs while also avoiding local adverse effects, such as oropharyngeal candidiasis and dysphonia, which may arise with the use of inhaled corticosteroids (ICS).^[5]

Given that over 34 million persons in India suffer from asthma, a sustainable approach that may be used in clinical settings to increase controller therapy adherence is required. Pharmacists may therefore easily instruct patients on correct breathing techniques and contribute significantly to the improvement of asthma control status.^[6] Effective communication is needed to identify individual barriers and interventions to improve adherence.^[7] More than 25% of patients do not receive adequate instructions on how to use inhalers, according to studies. Ineffective inhalation methods can increase the likelihood of both local and systemic side effects and have a detrimental impact on the way medications are deposited in the pulmonary target region.^[8] Therefore, the present study evaluated the relationship between inhaler use technique and asthma control in non-adherent patients.

MATERIALS AND METHODS:

Study Design: A community based prospective study was carried out to evaluate the relationship between asthma control and inhaler use technique in non-adherent adult patients in Mangalore.

Study Duration: The study was conducted for a duration of 6 months from March 2023 – August 2023.

Sample Size: The sample taken for the study was 106 which was based on convenience sampling method. These subjects were randomly allocated to control and intervention group, 53 in each.

Ethical Clearance: Ethical Clearance was obtained from the Institutional Ethics Committee (IEC) of Srinivas Institute of Medical Science and Research Centre (SIMS & RC), Mangalore.

Study Criteria:

Inclusion Criteria:

• Patients aged 18 years or above, of both genders (male and female).
•  Patients who are non-adherent to their inhalers.
• Participants willing to participate in the study.

Exclusion Criteria:

• Patients terminally ill, bedridden unconscious, not willing to participate

Data Collection:

Data(s) were collected using data collection form through direct interaction with the study subjects at their residences. The data collection forms were prepared which included patient name, gender, age, and height along with information regarding asthma control, inhaler adherence and technique. Adherence to treatment was assessed using a validated TAI questionnaire, while asthma control was evaluated through ACT and % predicted PEF using a peak flow meter.

Assessment Of Inhaler Adherence:

All recruited patients were given the 10-item TAI to assess their level of adherence to chronic inhalation therapy and determine whether improper device use could contribute to non-adherence. The 10-item TAI, which identifies patients with poor adherence and their degree of adherence, is one of two complementing questionnaires that can be utilized independently based on care needs. The degree of adherence increases with the 10-item TAI score (50 points = good adherence; <50 xss=removed>[9]

Assessment Of Asthma Control:

The Asthma Control Test (ACT) was used to evaluate the patients' asthma control. The ACT consists of five questions with a response scale from 1 (poor control) to 5 (excellent control), which are separated into four areas. Controlled asthma is indicated by total scores greater than 19, and uncontrolled asthma is indicated by scores less than 19. ^[10]

Assessment Of Inhaler Technique:

A validated checklist for each device was used to evaluate the patients' inhaler technique. With 10 steps for DPIs and SMIs, 11 steps for MDIs, and 12 steps for MDI with valved holding chamber (VHC) and autohaler, these checklists included all the necessary processes. The ratio of the number of right steps to the total number of steps was used to compute the inhaler score. Critical mistakes are those that, on their own, will seriously hinder the drug's ability to reach the lungs. (For instance, failing to remove the device's cap, failing to shake a MDI or autohaler, improperly loading a DPI or SMI or autohaler, or failing to take a deep and forceful breath via a DPI).^[11]

Study Procedure:

• The present study evaluated relationship of asthma control and inhaler technique.
• This study was a part of our main study which was a community based interventional study to assess and improve asthma inhaler adherence, control and inhaler technique.
• During the home visit, the subjects were explained about the study and patient consent was obtained for collecting data.

• Based on the Test of the Adherence to Inhalers (TAI) score, patients were categorized according to adherence status, of which non-adherent participants (TAI<50>
• Intervention group received verbal counselling, inhaler technique demonstration and a PIL (Patient Information Leaflet), while control group didn’t receive any form of intervention.
• Patients were followed up after 3 months of intervention to evaluate the relationship of asthma control and inhaler use technique.

Statistical Analysis:

The data collected were analysed using Microsoft Excel and SPSS. Suitable statistical test such as student T test and Chi square test were applied. P-value of <0>

Result:

Demographic Details And Baseline Clinical Characteristics:

In the present study majority were females (54 of 106). Mean age was 50.09±11.17. 106 non adherent subjects identified were eligible for the intervention phase of the study. They were randomly assigned to either the intervention group or the control group, with 53 patients in each group. Patients in both the intervention and control group had similar demographic characteristics, ED/hospital visits, asthma control and technique at baseline. (Table 1). Out of 106 inhalers there were 59 MDIs, 37 DPIs, 9 SMIs and 1 Others. (Fig 1).

Table 1: Baseline demographics and clinical characteristics of patients in both group

       
           
       
  Fig 1: Percentage of non-adherent asthma patients according to inhaler sub-types

Table 2: Relationship between Inhalation technique and Asthma control using ACT and %predicted PEF in post-test (N=106)

Values are expressed as n. ACT=Asthma Control Test. PEF=Peak Expiratory Flow

Relationship Of Asthma Control And Inhaler Technique:

Table 2 delineates the relationship of inhaler technique and asthma control. The current study, found that subjects in the intervention group, who received education on proper inhaler technique, were more likely to have controlled asthma and efficient inhaler technique than subjects in the control group, who did not receive education on proper inhaler technique (27 vs 3).  Fig 2 illustrates in the intervention group that more number of patients with controlled asthma had efficient inhaler technique. Also, more number of patients with un-controlled asthma had in-efficient inhaler technique. Further, subjects with inefficient inhaler technique were more likely to have uncontrolled asthma and lower predicted PEF than subjects with efficient inhaler technique. This association was statistically significant, with a p-value of <0>