Adherence of Inhalers in COPD and Asthma A Comparative Analysis of Breath Actuated-Pressurized Metered Dose Inhalers (BA-pMDI) Inhaler Devices and Other Inhaler Devices in the Management of Asthma and COPD

Title of the Study: Adherence of Inhalers in COPD and Asthma: A Comparative Analysis of Breath Actuated-Pressurized Metered Dose Inhalers (BA-pMDI) Inhaler Devices and Other Inhaler Devices in the Management of Asthma and COPD

**Background:**Asthma and chronic obstructive pulmonary disease (COPD) are highly prevalent respiratory conditions that require regular long-term medication management. Inhaler devices are specialized medical equipment intended to administer medication directly to the respiratory tract in order to treat conditions including chronic obstructive pulmonary disease and asthma. Choosing the right inhaler is particularly essential for both patient compliance and efficient medication delivery . Currently, there is a lack of comparative studies in India with larger sample sizes and longer follow-up periods to further validate the benefits of BA-pMDI adherence in real-world clinical settings. Therefore, the current study will be undertaken to understand the use and adherence of inhalers and compare the BA-pMDI to other inhalers in the treatment of asthma and COPD patients in India.

Objective:

1. To evaluate the adherence of the BA-pMDI device compared to other inhaler devices for treatment of Asthma and COPD patients.

2. To find out the factors affecting adherence to BA-pMDI and other inhaler devices among COPD and asthma patients.

Methodology:

Study Design: Multicentric observational study

Inclusion Criteria : Patients of either gender who are 18 years and above and understand English language and willing to participate in this study will be included. Patients diagnosed with asthma and COPD by the treating physician and prescribed inhaler as part of treatment of COPD or Asthma.

Exclusion Criteria: Individuals suffering from malignancies (AML, CML, Hodgkin’s Lymphoma, Systemic autoimmune disease), autoimmune diseases like SLE, and other immunosuppressive disorders. Individuals with any serious co-morbidity and existing end-organ damage, dementia and psychotic illness. Vulnerable patients (<18 years old, pregnant women), Patients who do not understand English

Sample Size: The targeted sample size for this study is 300 participants.

Expected outcomes

Primary outcome: To examine the adherence of the BA-pMDI device compared to other inhaler devices for treatment of asthmatic and COPD patients.

Secondary outcome: Identification of factors affecting adherence to the BA-pMDI devices and comparison to the different inhaler devices.

Statistical Methods: Data analysis, tabulation of descriptive statistics will be performed using SPSS 25.0 for Windows.