| CTRI Number |
CTRI/2019/04/018511 [Registered on: 09/04/2019] Trial Registered Prospectively |
| Last Modified On: |
08/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Systemic and local oxidative stress in COPD |
|
Scientific Title of Study
|
Systemic and local oxidative post-translational modification – S-glutathionylation in COPD |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit R Agarwal |
| Designation |
Research Scientist |
| Affiliation |
Chest Research Foundation |
| Address |
Sr. No 15, Marigold Premises,
Molecular Biology Dept.,
Room No. 5
Behind Gold Adlabs, Pune
Pune
MAHARASHTRA
411014
India |
| Phone |
020-49134338 |
| Fax |
|
| Email |
aagarwal@crfindia.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit R Agarwal |
| Designation |
Research Scientist |
| Affiliation |
Chest Research Foundation |
| Address |
Sr. No 15, Marigold Premises,
Molecular Biology Dept.,
Room No. 5
Behind Gold Adlabs, Pune
Pune
MAHARASHTRA
411014
India |
| Phone |
020-49134338 |
| Fax |
|
| Email |
aagarwal@crfindia.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit R Agarwal |
| Designation |
Research Scientist |
| Affiliation |
Chest Research Foundation |
| Address |
Sr. No 15, Marigold Premises,
Molecular Biology Dept.,
Room No. 5
Behind Gold Adlabs, Pune
Pune
MAHARASHTRA
411014
India |
| Phone |
020-49134338 |
| Fax |
|
| Email |
aagarwal@crfindia.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Science and Technology. ECR_2017_000950 |
|
|
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,
Molecular Biology Dept.,
Room No. 5
Behind Gold Adlabs
Pune
MAHARASHTRA |
020-49134338
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
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy non-smokers, smokers and biomass fuel users |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Healthy non-smoker
Be at least 40 years of age
Provide written informed consent
Never smoker and not exposed to biomass for >10 years
No major abnormality on clinical examination
Normal spirometry, FEV1/FVC>0.70 (or IOS 80-120% predicted if not able to perform Spirometry)
FEF25-75 > 65%
DLCO ≥ 80% predicted
Body plethysmography TLC ≥ 80% predicted
Healthy smoker
Be at least 40 years of age
Provide written informed consent
Be smoking tobacco in the form of bidi or cigarettes for at least 10 pack years
No major abnormality on clinical examination
Normal spirometry, FEV1/FVC>0.70 (or IOS 80-120% predicted if not able to perform Spirometry)
FEF25-75 > 65%
DLCO ≥ 80% predicted
Body plethysmography TLC ≥ 80% predicted
Healthy Biomass user
Be at least 40 years of age
Provide written informed consent
Be exposed to biomass for at least 10 fuel-years (women)/ 20 fuel-years (men) (exposure of 2hrs/day for 10 years) after adulthood
No major abnormality on clinical examination
Normal spirometry, FEV1/FVC>0.70 (or IOS 80-120% predicted if not able to perform Spirometry)
FEF25-75 > 65%
DLCO ≥ 80% predicted
Body plethysmography TLC ≥ 80% predicted
Tobacco smoking COPD
Be at least 40 years of age
Provide written informed consent
Be smoking tobacco in the form or bidi or cigarettes for at least 10 pack-years
Have a clinical diagnosis of COPD (GOLD stage I to III) and post-bronchodilator FEV1/FVC ratio <0.70) (or IOS X > 1500 % predicted if not able to perform Spirometry)
DLCO < 80% predicted
Body plethysmography TLC < 80% predicted
Non-smoking COPD
Be at least 40 years of age
Provide written informed consent
Be exposed to biomass for at least 10 fuel-years (women)/ 20 fuel-years (men) after adulthood
Have a clinical diagnosis of COPD (GOLD stage I to III): post-bronchodilator FEV1/FVC ratio <0.70) (or IOS (or IOS X > 1500 % predicted if not able to perform Spirometry))
DLCO < 80% predicted
Body plethysmography TLC < 80% predicted
Never smoker
FEV1 reversibility <400 mL to rule out asthma
|
|
| ExclusionCriteria |
| Details |
Subjects suffering from comorbidities such as diabetes.
Very 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 |
| Identification of proteins modified by oxidative post translational modification in COPD patients |
Not applicable as this is an observational study and does not involve an intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
1 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/04/2019 |
| 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
|
Oxidative stress is a hallmark characteristic of COPD but the limited success with current antioxidants indicates the lack of complete understanding of the mechanisms involved in the generation of this stress.Thus, the identification of proteins affected by this oxidative stress as a result of tobacco and biomass smoke exposure will help us pinpoint the specific targets of this oxidative stress against which future therapies could be designed. |