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CTRI Number  CTRI/2025/12/098503 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 02/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Changes in Lung Oscillometry Parameters among Healthy Adults After Inhaled Bronchodilator Use 
Scientific Title of Study   Bronchodilator Response of Lung Oscillometry Parameters in Healthy Adults: A Pilot Study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sajal De 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Raaipur 
Address  Dept of Pulmonary Medicine All India Institute of Medical Sciences GE Road Raipur 492099

Raipur
CHHATTISGARH
492099
India 
Phone  9406573825  
Fax    
Email  sajalde@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Sajal De 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Raaipur 
Address  Dept of Pulmonary Medicine All India Institute of Medical Sciences GE Road Raipur 492099

Raipur
CHHATTISGARH
492099
India 
Phone  9406573825  
Fax    
Email  sajalde@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Sajal De 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Raaipur 
Address  Dept of Pulmonary Medicine All India Institute of Medical Sciences GE Road Raipur 492099

Raipur
CHHATTISGARH
492099
India 
Phone  9406573825  
Fax    
Email  sajalde@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raipur 
 
Primary Sponsor  
Name  NIL 
Address  Not applicable 
Type of Sponsor  Other [Non funded] 
 
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 
Sajal De  All India Institute of Medical Sciences, Raipur  Dept of Pulmonary Medicine 4th Floor, D block All India Institute of Medical Sciences Ge Road Raipur-492099
Raipur
CHHATTISGARH 		 9406573825

sajalde@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Changes in oscillometry parameters after receiving bronchodilator 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Salbutamol  Eligible individuals will receive 400 micrograms of inhaled sulbutamol after the initial oscillometry to assess the changes after the salbutamol 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  i. No prior history of respiratory disease and non smoker 
 
ExclusionCriteria 
Details  1. Recent respiratory infection (within 4 weeks).
ii. Known cardiac disease or uncontrolled systemic illness.
iii.No prior history of respiratory disease (asthma, COPD, bronchiectasis, ILD, pulmonary tuberculosis, etc.).
iv. Never-smoker
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome variables will be whole-breath resistance at 5 Hz (R5), whole-breath reactance at 5 Hz (X5), frequency dependence of resistance (R5–20), resonant frequency (Fres), and reactance area (AX), defined as the integral of reactance between 5 Hz and Fres.  The outcome variables will be whole-breath resistance at 5 Hz (R5), whole-breath reactance at 5 Hz (X5), frequency dependence of resistance (R5–20), resonant frequency (Fres), and reactance area (AX), defined as the integral of reactance between 5 Hz and Fres. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the variability of oscillometry parameters across different age groups andbetween genders following administration of inhaled bronchodilator.

 		 After bronchodilator  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   14/12/2025 
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="2"
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  

Oscillometry is a simple, non-invasive technique used to assess lung mechanics, particularly for diagnosing small airway dysfunction. Unlike spirometry, oscillometry does not require forceful breathing maneuvers and is increasingly being adopted in clinical practice for the management of obstructive lung diseases. Similar to spirometry, bronchodilator responsiveness of oscillometry is assessed after administering 400 µg of inhaled salbutamol. However, the criteria for defining a bronchodilator response in oscillometry remain unclear and not well established. This study aims to assess changes in oscillometry parameters following bronchodilator administration in a healthy adult population, providing baseline data that may help guide future clinical interpretation.

 
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