| 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 |
| Trial Acronym |
|
|
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
|
|
|
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
|
|
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 |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ï‚· 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
ï‚· 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
ï‚· 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
ï‚· 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)
ï‚· 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
ï‚· 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 |
1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
1 |
|
|
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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |