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CTRI Number  CTRI/2024/02/062955 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 19/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Use and adherence of Inhalers in COPD and Asthma patients 
Scientific Title of 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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sundeep Salvi 
Designation  Director 
Affiliation  Chest Research and Training Private Limited  
Address  Dept of Research Room No Directors Chamber Floor First Floor Institute Chest Research and Training Pvt Ltd Building Faith Center Lane No 4 Survey No 232 Plot No82 Sakorenagar Vimannagar

Pune
MAHARASHTRA
411014
India 
Phone  9921211000  
Fax    
Email  sundeepsalvi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sundeep Salvi 
Designation  Director 
Affiliation  Chest Research and Training Private Limited  
Address  Dept of Research Room No Directors Chamber Floor First Floor Institute Chest Research and Training Pvt Ltd Building Faith Center Lane No 4 Survey No 232 Plot No82 Sakorenagar Vimannagar

Pune
MAHARASHTRA
411014
India 
Phone  9921211000  
Fax    
Email  sundeepsalvi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Snehal Kulkarni 
Designation  Head 
Affiliation  Chest Research and Training Private Limited  
Address  Dept of Research Room No Directors Chamber Floor First Floor Institute Chest Research and Training Pvt Ltd Building Faith Center Lane No 4 Survey No 232 Plot No82 Sakorenagar Vimannagar

Pune
MAHARASHTRA
411014
India 
Phone  9762527200  
Fax    
Email  rrn_hod@purefoundation.in  
 
Source of Monetary or Material Support  
Cipla Ltd Penninsula Business park Ganpat rao Kadam Marg Lower Parel West Mumbai 
 
Primary Sponsor  
Name  Cipla Ltd 
Address  Cipla Ltd., 289, Bellasis Road, Opposite Sahil Hotel, Mumbai Central East, Mumbai, Maharashtra 400008 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Snehal Kulkarni  Pulmocare Research And Education (PURE) Foundation  1st Floor FAITH Centre Survey NO 232 Sakore Nagar Viman Nagar Pune Maharashtra
Pune
MAHARASHTRA 		 9762527200

ssalvi@purefoundation.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J459||Other and unspecified asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  Individuals suffering from malignancies AML and 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 less than 18 years old pregnant women Patients who do not understand English 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To examine the adherence of the BA-pMDI device compared to other inhaler devices for treatment of asthmatic and COPD patients  9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Identification of factors affecting adherence to the BA-pMDI devices and comparison to the different inhaler devices.  9 months 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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.


 
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