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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  
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J439||Emphysema, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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