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CTRI Number  CTRI/2018/01/011441 [Registered on: 19/01/2018] Trial Registered Retrospectively
Last Modified On: 05/02/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Metabolic phenotype in COPD 
Scientific Title of Study   Metabolic phenotype characterization of inflammatory cells in smoking and non-smoking COPD  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amit Agarwal 
Designation  Research Scientist 
Affiliation  Chest Research Foundation 
Address  Sr. No 15, Marigold Premises, Behind Gold Adlabs, Pune

Pune
MAHARASHTRA
411014
India 
Phone  2049134355  
Fax    
Email  aagarwal@crfindia.com  
 
Details of Contact Person
Scientific Query
 
Name  Amit Agarwal 
Designation  Research Scientist 
Affiliation  Chest Research Foundation 
Address  Sr. No 15, Marigold Premises, Behind Gold Adlabs, Pune


MAHARASHTRA
411014
India 
Phone  2049134355  
Fax    
Email  aagarwal@crfindia.com  
 
Details of Contact Person
Public Query
 
Name  Amit Agarwal 
Designation  Research Scientist 
Affiliation  Chest Research Foundation 
Address  Sr. No 15, Marigold Premises, Behind Gold Adlabs, Pune


MAHARASHTRA
411014
India 
Phone  2049134355  
Fax    
Email  aagarwal@crfindia.com  
 
Source of Monetary or Material Support  
Chest Research Foundation 
 
Primary Sponsor  
Name  Chest Research Foundation 
Address  Sr. No 15 Marigold Premises, Behind Gold Adlabs, 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 
Amit Agarwal  Chest Research Foundation  Sr. No 15, marigold premises, Behind Gold Adlabs, Pune
Pune
MAHARASHTRA 
2049134355

aagarwal@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
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers who may or may not be exposed to cigarette or biomass smoke and are not suffering from COPD. 
Patients  J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details   Healthy non-smoker
o Be at least 40 years of age
o Provide written informed consent
o Never smoker and not exposed to biomass for >10 years
o No major abnormality on clinical examination
o Normal spirometry, FEV1/FVC>0.70
 Healthy smoker
o Be at least 40 years of age
o Provide written informed consent
o Be smoking tobacco in the form of bidi or cigarettes for at least 10 pack years
o No major abnormality on clinical examination
o Normal spirometry, FEV1/FVC>0.70
4
 Healthy Biomass user
o Be at least 40 years of age
o Provide written informed consent
o Be exposed to biomass for at least 10 fuel-years (exposure of 2hrs/day for 10 years)
after adulthood
o No major abnormality on clinical examination
o Normal spirometry, FEV1/FVC>0.70
 Tobacco smoking COPD
o Be at least 40 years of age
o Provide written informed consent
o Be smoking tobacco in the form or bidi or cigarettes for at least 10 pack-years
o Have a clinical diagnosis of COPD (GOLD stage I to III) and post-bronchodilator
FEV1/FVC ratio <0.70)
 Non-smoking COPD
o Be at least 40 years of age
o Provide written informed consent
o Be exposed to biomass for at least 10 fuel-years after adulthood
o Have a clinical diagnosis of COPD (GOLD stage I to III): post-bronchodilator
FEV1/FVC ratio <0.70)
o Never smoker
o FEV1 reversibility <400 mL to rule out asthma 
 
ExclusionCriteria 
Details  Severe COPD patients would be excluded as the process of sputum induction may
worsen their condition
 History of lung condition other than COPD including respiratory infectious diseases
like tuberculosis, asthma, interstitial lung disease, etc 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mitochondrial respiration in PBMCs of healthy and COPD patients 
 
Secondary Outcome  
Outcome  TimePoints 
None 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   07/11/2016 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Brief Summary   COPD is characterized by a lot of metabolic changes and we wanted to understand the changes in cellular metabolism in smoking and non-smoking COPD patients. We hypothesized that tobacco and biomass smoke are made up of different constituents and would affect the cells in different ways although both lead to COPD.  
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