FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/08/020738 [Registered on: 16/08/2019] Trial Registered Prospectively
Last Modified On: 14/08/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Randomized, Crossover Trial 
Public Title of Study   An investigator initiated study to study how well does a newly developed spirometer by Cipla Ltd. work as compared to the spirometer already available in the market.  
Scientific Title of Study   A randomized, open-label, three side crossover study investigator initiated study to validate the i-Spiro (Cipla) by comparing Cipla Pneumotach sensor based spirometer and Koko spirometer (pneumotach sensor which is based on conventional spirometer) in healthy adult subjects, adult patients having asthma and adult patients having Chronic Obstructive Pulmonary Disease (COPD). 
Trial Acronym  iSpiro Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Komalkirti Apte 
Designation  Head, Clinical trials division 
Affiliation  Chest Research Foundation 
Address  Room number 18, ground floor, Survey No. 15, Marigold Premises, Kalyani Nagar, Pune

Pune
MAHARASHTRA
411014
India 
Phone    
Fax    
Email  drkomalapte@crfindia.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Komalkirti Apte 
Designation  Head, Clinical trials division 
Affiliation  Chest Research Foundation 
Address  Room number 18. ground floor, Survey No. 15, Marigold Premises, Kalyani Nagar, Pune

Pune
MAHARASHTRA
411014
India 
Phone    
Fax    
Email  drkomalapte@crfindia.com  
 
Details of Contact Person
Public Query  
Name  Dr Komalkirti Apte 
Designation  Head, Clinical trials division 
Affiliation  Chest Research Foundation 
Address  Room number 18, ground floor, Survey No. 15, Marigold Premises, Kalyani Nagar, Pune

Pune
MAHARASHTRA
411014
India 
Phone    
Fax    
Email  drkomalapte@crfindia.com  
 
Source of Monetary or Material Support  
Chest Research Foundation, Survey number 15, Marigold Premises, Kalyani Nagar, Pune 411014, Maharashtra, India 
 
Primary Sponsor  
Name  Chest Research Foundation 
Address  Survey No. 15, Marigold Premises, Kalyani Nagar, Pune 411014 
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 
Dr Komalkirti Apte  Chest Research Foundation  Room number 18, ground floor, Survey No. 15, Marigold Premises, Kalyani Nagar, Pune
Pune
MAHARASHTRA 		 9623023295

drkomalapte@crfindia.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Chest Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Healthy subjects or stable asthma patients or stable COPD patients
2.Subjects >18 years
3.Medical history / medical records for evidence of asthma and COPD 
 
ExclusionCriteria 
Details  1.Acute exacerbation of bronchial asthma or COPD or hospitalization/emergency room visits due to asthma/COPD exacerbation within the last 6 weeks prior to study participation
2.History of any Abdominal/Thoracic surgery in the last 1 month
3.Any eye surgery in the last 1 month
4.Uncontrolled or unstable asthma and COPD status in the subjects
5.Severe concomitant disease which may have an impact on the spirometric performance such as any unstable health conditions viz cardiovascular, pulmonary, abdominal, neurological or any endocrine disorders
6.Female subject who is pregnant
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Difference in FVC and FEV1 value measured by the Koko Spirometer and the iSPiro is not more than 500 ml and 350 ml respectively.   24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
No significant difference in inter test and intra test values obtained  24 hours 
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
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)   19/08/2019 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is an investigator initiated study to compare the iSpiro (spirometer manufactured by Cipla Ltd.) with the conventional Koko spirometer used in routine clinical practice.  This study will be done in 81 participants which include healthy adult volunteers, adult asthmatic patients and COPD patients. This is a randomized, open-label, three-way crossover investigator initiated study.

The primary objective is to validate the i-Spiro (Cipla) by comparing Cipla Pneumotach sensor based spirometer and Koko spirometer used in clinical practice. The secondary objective of this study is to assess the intra-instrument variability and inter-instrument variability of the i-Spiro (Cipla). The study hypothesis is that the iSpiro is as good as the conventional Koko spirometer with an estimated difference of 500 ml and 350 ml in Forced vital capacity and forced expiratory volume in the 1st second respectively. 

 
Close