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CTRI Number  CTRI/2025/08/092275 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   A Study to Understand Comfort and Ease of Use Of A Novel Spacer Device when Connected with Inhalers in Participants with Asthma and COPD (Chronic Obstructive Pulmonary Disease) 
Scientific Title of Study   Acceptability and Usability of the A202 Spacer Device as an add on with pressurized Metered Dose Inhaler (pMDI) in Patients with Asthma and COPD 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Uma Maheswari K  
Designation  Professor Pulmonary Medicine 
Affiliation  St Johns Medical College 
Address  Dept of Pulmonary Medicine St Johns Medical College and Hospital Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9483702412  
Fax    
Email  uma.mk@stjohns.in   
 
Details of Contact Person
Scientific Query  
Name  Dr Uma Maheswari K  
Designation  Professor Pulmonary Medicine 
Affiliation  St Johns Medical College 
Address  Dept of Pulmonary Medicine St Johns Medical College and Hospital Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9483702412  
Fax    
Email  uma.mk@stjohns.in   
 
Details of Contact Person
Public Query  
Name  Dr Uma Maheswari K  
Designation  Professor Pulmonary Medicine 
Affiliation  St Johns Medical College 
Address  Dept of Pulmonary Medicine St Johns Medical College and Hospital Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9483702412  
Fax    
Email  uma.mk@stjohns.in   
 
Source of Monetary or Material Support  
AeroDel Technology Innovations Private Limited Plot 104 Flat 401 Suman Heritage sector 28 Nerul Navi Mumbai 400706 
 
Primary Sponsor  
Name  AeroDel Technology Innovations Private Limited 
Address  Plot 104 Flat 401 Suman Heritage sector 28 Nerul Navi Mumbai 400706 
Type of Sponsor  Other [Medical Devices Company] 
 
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 
DR UMA MAHESHWARI K  St Johns Medical College Hospital  Department of Pulmonary Medicine, 4th floor B extension, St Johns Medical College Hospital, Sarjapur road Bangalore 560034
Bangalore
KARNATAKA 		 9483702412

uma.mk@stjohns.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Johns Medical College Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J454||Moderate persistent asthma, (3) ICD-10 Condition: J453||Mild persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A202 Compact Spacer Device  The compact spacer device will be kept attached to metered dose inhaler for 8 weeks and the usability will be assessed. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  For Asthma Adults aged 18 to 65 years For COPD 40 to 65 years age Participants willing to participate in the study Participants who are already using metered dose inhaler with spacer brands available in the market

 
 
ExclusionCriteria 
Details  Pregnant women and breastfeeding mothers Patients admitted with acute exacerbation of asthma or COPD Patients who are on nebulized medications Participants who have psychiatric illness or any other severe comorbid illness which may preclude participation in study
Participants with an underlying end stage lung disease
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patient comfort in using the device will be assessed based on responses to a structured questionnaire  Patient comfort in using the device will be assessed fortnightly at 2nd, 4th, 6th and 8th week. 
 
Secondary Outcome  
Outcome  TimePoints 
Compliance to metered dose inhaler with attached spacer  Week 2 week 4 week 6 week 8 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/08/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This trial aims to study the acceptability, usability and compliance to inhaled medication with a spacer pre-attached to the standard-of-care metered dose inhaler device in participants with asthma and COPD. Spacers are standard add-ons to metered dose inhalers and have been proven to enhance drug delivery, but are bulky to carry around and hence lack portability. 
The novel spacer device to be used in the present study is compact and can be kept attached to the metered dose inhaler due to its smaller form factor and due to the fact that it can be left attached due to it’s hinge-like attachment feature, which makes it portable. Participants will receive standard doses of inhaled medication, but will be able to carry around their inhalers with the spacer attached, which improves drug delivery.
The study aims to study the acceptability of this attached spacer as well as compliance to inhaled therapy with the added device over a 8-week period
 
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