| CTRI Number |
CTRI/2021/02/031450 [Registered on: 22/02/2021] Trial Registered Prospectively |
| Last Modified On: |
07/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Difference between Smoker and Non Smoker COPD |
|
Scientific Title of Study
|
Comparision of Clinico-Radiological Profile Between Smoker and Nonsmoker Phenotypes of COPD at a Tertiary Care Centre in East India |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debasis Behera |
| Designation |
Assistant Professor |
| Affiliation |
KIMS, Bhubaneswar |
| Address |
Department of Pulmonary Medicine Kalinga Institute of Medical Science, Bhubaneswar
Khordha
Beleswar, Nayabazar, Cuttack 753004 Cuttack ORISSA 751024 India |
| Phone |
09971852101 |
| Fax |
|
| Email |
drdebasis8@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Debasis Behera |
| Designation |
Assistant Professor |
| Affiliation |
KIMS, Bhubaneswar |
| Address |
Department of Pulmonary Medicine Kalinga Institute of Medical Science, Bhubaneswar
Khordha
Beleswar, Nayabazar, Cuttack 753004 Cuttack ORISSA 751024 India |
| Phone |
09971852101 |
| Fax |
|
| Email |
drdebasis8@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Debasis Behera |
| Designation |
Assistant Professor |
| Affiliation |
KIMS, Bhubaneswar |
| Address |
Department of Pulmonary Medicine Kalinga Institute of Medical Science, Bhubaneswar
Khordha
Beleswar, Nayabazar, Cuttack 753004 Cuttack ORISSA 751024 India |
| Phone |
09971852101 |
| Fax |
|
| Email |
drdebasis8@gmail.com |
|
|
Source of Monetary or Material Support
|
| KIMS Hospital, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
KIMS HOSPITAL |
| Address |
BHUBANESWAR
ODISHA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Debasis Behera |
Kalinga Institute of Medical Science, Pulmonary Medicine OPD, Room No.8 |
Bhubaneswar Khordha ORISSA |
09971852101
drdebasis8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kalinga Institute of Medical Science, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J439||Emphysema, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed as COPD with age > 40 years attending to OPD in Department of Pulmonary Medicine, KIMS, Bhubaneswar will be included in study. |
|
| ExclusionCriteria |
| Details |
1. Subjects with other lung diseases such as pulmonary tuberculosis, bronchiectasis, pneumonia, interstitial lung disease, or pleural effusion, will be excluded, as patients who have airflow limitation due to abnormalities in the large airways.
2. Patients with significant comorbidities like severe heart failure, chronic renal failure and hepatic failure will be excluded.
3. Patients with exacerbation in last one month will also be excluded.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the differences in clinical presentation between smoker & non-smoker COPD.
2. To determine the difference in radiology between smoker & non-smoker COPD.
|
one to two years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine various risk factors associated with NS-COPD
|
one to two years |
|
|
Target Sample Size
|
Total Sample Size="490" Sample Size from India="490"
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)
|
22/02/2021 |
| 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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The occurrence of COPD in never-smokers is not widely studied, despite the fact that the relative burden of COPD in never-smokers is high in developing and developed countries, accounting for about 30% of all COPD in the community. Tobacco smoking has been an established risk factor for COPD for over five decades and virtually all our knowledge about the clinical, physiological, pathological and radiological features of COPD, as well as rates of decline in lung function and efficacies of various treatments is based on this population. Exposure to biomass smoke during cooking in poorly ventilated homes, high levels of ambient air pollution, occupational exposures to dust and gases, ambient ozone exposure, poverty, repeated respiratory tract infections during childhood, poorly controlled chronic persistent asthma and previous tubercular lung disease are also non-smoking risk factors for COPD. Despite the relatively high burden of COPD among never smokers, relatively little is known about this phenotype. To address this issue, we will undertake a prospective observational study to investigate the differences in clinical, physiological, radiological, and blood markers between smoking (S-COPD) and non-smoking COPD (NS-COPD) subjects. |