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CTRI Number  CTRI/2024/09/073954 [Registered on: 17/09/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Study To Compare Cipla’s Oscillometer With The Tremoflo C-100 oscillometer in Healthy Participants, Asthmatic And COPD Patients. 
Scientific Title of Study   A Randomized, Open Label, Comparative, Cross-Over, Multicentre Study To Compare Oscillometry Measurements Of Cipla’s Oscillometer With The Reference Device Tremoflo C-100 In Healthy Participants, Asthmatic And COPD Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CP/10/24 ,Version no.01, dated 16/08/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jaideep Gogtay  
Designation  Executive Vice President, Global Chief Medical Officer. 
Affiliation  Cipla Limited 
Address  Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai.

Mumbai
MAHARASHTRA
400008
India 
Phone  02223025145  
Fax    
Email  jgogtay@cipla.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandesh Sawant 
Designation  Vice President, Head- Clinical Trials 
Affiliation  Cipla Limited 
Address  Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai.

Mumbai
MAHARASHTRA
400008
India 
Phone  02223025006  
Fax    
Email  sandesh.sawant3@cipla.com  
 
Details of Contact Person
Public Query  
Name  Mr Abhijit Vaidya 
Designation  Associate Director, Clinical Trials 
Affiliation  Cipla Limited 
Address  Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai.

Mumbai
MAHARASHTRA
400008
India 
Phone  02223025623  
Fax    
Email  abhijit.vaidya@cipla.com  
 
Source of Monetary or Material Support  
Cipla Ltd, 289 Bellasis Road, Mumbai Central, Mumbai, Maharashtra, 400008, India 
 
Primary Sponsor  
Name  Cipla Ltd 
Address  Cipla Ltd, 289 Bellasis Road, Mumbai Central, Mumbai, Maharashtra, 400008, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr GMV Kasiram  Aditya Hospital Guntur-Andhra Pradesh  Roomno.05-First-Floor Department: Pulmonology Division: Respiratory MedicineAditya Multispeciality Hospital,3rd Line, Gunturvari Thota, Opp, Road RTC Bus,Stand. Kamaraju Scan Centre road Guntur-522001, Andhra Pradesh-India”
Guntur
ANDHRA PRADESH 		 9966083232

kasiram1488@gmail.com 
Dr Raja Dhar  Calcutta Medical Research Institute  First-Floor Department Pulmonology Division Pulmonary Medicine Calcutta Medical Research Institute (CMRI) 7/2 Diamond Harbour Road Kolkata 700027
Kolkata
WEST BENGAL 		 9831855512

docaardee@yahoo.com 
Dr S Balamurugan  Chest & Diabetes Research Institute  Room No.: 2, Department and Division Respiratory Medicine, First Cross Street, Janaki Nagar Ex tension, Valasaravakka m, Chennai, Tamil Nadu – 600087, Chennai
Chennai
TAMIL NADU 		 9841090860

dr.s.bala@gmail.com 
Dr Vaibhav Pandharkar  Excellentia Consulting Services  Room No F 12 A Department Pulmonary Medicine Division Pulmonary Medicine F-Plaza Residences Wadgaonsheri
Pune
MAHARASHTRA 		 9923111646

drvaibhavpandharkar@gmail.com 
Dr Supraja K  Medway Institute of Pulmonology  Room no.109-First floor Department: Pulmonology and Division : Respiratory Medicine Medway Institute of Pulmonology 22/8, 4th Cross Street, Trustpuram, Kodambakkam Chennai- 600024
Chennai
TAMIL NADU 		 9500049868

dr.supraja.k@medwayhospitals.com 
Dr Dhruva Chaudhry   Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences or PGIMS Rohtak  Room No. 17 Department Pulmonary & Critical Care Division Pulmonary & Critical Care Medicine Near old emergency ward Rohtak 124001 Haryana
Rohtak
HARYANA 		 9416051616

dhruvachaudhry@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional Ethics Committee Pt. B. D. Sharma, PGIMS, Rohtak (Dr Dhruva Chaudhry)  Submittted/Under Review 
Institutional Ethics Committee, Aditya Multi Speciality Hospital (Dr GMV Kasiram)  Approved 
Institutional Ethics Committee- The Calcutta Medical Research Institute (Dr Raja Dhar)  Approved 
Institutional Ethics Committee-Medway Hospital (Dr Supraja K)  Approved 
Ripon Independent Ethics Committee (Dr S Balamurugan)  Approved 
Royal Pune Independent Ethics Committee (Dr Vaibhav Pandharkar)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers  
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  Cipla’s Oscillometry Device   Impulse Oscillometry -is a Diagnostic Modalities (As a Medical Diagnostic Device) 
Comparator Agent  Tremoflo C-100  Impulse Oscillometry -is a Diagnostic Modalities (As a Medical Diagnostic Device) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Voluntarily given written signed dated Informed consent from participants.
2. Participants of either gender of age between 18 years to 75 years (both inclusive).
3. Healthy participants [participants who do not have asthma or COPD or other pulmonary disease as per investigator discretion] or documented diagnosis of Asthma or COPD which is confirmed by Spirometry.
 
 
ExclusionCriteria 
Details  1. Participants who are unable to perform acceptable Oscillometry and/or Spirometry.
2. Pregnant and lactating women.
3. Significant lung/airway diseases other than the asthma or COPD diagnosis for each of the subject groups.

4. Any significant deformity of the thorax or vertebral column that may cause persistent airflow limitation or altered lung volumes.
5. Uncontrolled or unstable asthma / COPD status in the subjects.
6. Severe concomitant disease or conditions which may have an adverse impact on the performance of oscillometry or spirometry such as any unstable health conditions viz cardiovascular, pulmonary, abdominal, neurological or any endocrine disorders or recent surgeries.


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of the impedance (resistance and reactance) between Cipla’s Oscillometry Device 1 and 2 versus the reference device Tremoflo C-100 in healthy participants, asthmatic and COPD patients.   Single Day 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of the impedance (resistance and reactance) between the two Cipla Oscillometry devices 1 and 2 in healthy participants, asthmatic and COPD patients.   Single day. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   30/09/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   A written informed consent will be obtained from all participants to assess them for eligibility for the study. Demographic data and all assessments will be recorded. Respiratory system examination will be done. To be eligible for the study the participants should have withheld their bronchodilators before performing pulmonary function test as per the time described in this protocol. Participants who are eligible will undergo assessments with Oscillometers first and followed by Spirometry. Participants will be randomized and crossed over to Cipla’s Oscillometry Device 1 and 2 and Tremoflo C-100. Spirometry will be performed pre-bronchodilator (for all participants) and post-bronchodilator (in asthma and COPD). 
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