| CTRI Number |
CTRI/2021/09/036457 [Registered on: 13/09/2021] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study small-airway functional abnormalities in the lungs in patients suffering from chronic obstructive pulmonary disease |
|
Scientific Title of Study
|
Evaluation of small-airway dysfunction in chronic obstructive pulmonary disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Kiran Rath |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Pulmonary Medicine, D block, AIIMS, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8895913837 |
| Fax |
|
| Email |
dr.amit.rath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajal De |
| Designation |
Professor and Head of the Department |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Pulmonary Medicine, D Block, AIIMS, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9406573825 |
| Fax |
|
| Email |
sajalde@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajal De |
| Designation |
Professor and Head of the Department |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Pulmonary Medicine, D Block, AIIMS, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9406573825 |
| Fax |
|
| Email |
sajalde@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
Amit Kiran Rath |
| Address |
Department of Pulmonary Medicine, D block, AIIMS, Raipur |
| Type of Sponsor |
Other [self] |
|
|
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 Kiran Rath |
Department of pulmonary Medicine, |
Department Of Pulmonary Medicine, D Block, AIIMS, Raipur,492099
Raipur
CHHATTISGARH |
8895913837
dr.amit.rath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Raipur |
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 |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of COPD as per 2021 GOLD (Global initiatives for Obstructive Lung Disease) guidelines (Post BDR FEV1/FVC < 0.7 and β2 agonists reversibility of less than 12% or 200ml)(36) |
|
| ExclusionCriteria |
| Details |
– Not able to perform an acceptable test
– Hemodynamically compromised
– Exacerbation of COPD within past 4 weeks
– Other lung diseases like TB, asthma, interstitial lung diseases, structural lung diseases, e.g., bronchiectasis, lung cancer, respiratory infection in 2 weeks, history of pulmonary surgery
– Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of small airway dysfunction in COPD groups |
at the point of interaction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| monitoring lung function parameters after optimised treatment |
3 months and 1 year |
| quality of life as CAT score |
with oscillatory technique parameters, like R5, X5, EFL, R5-19 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/09/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a cross-sectional study to observe the prevalence of small airway dysfunction in different COPD groups. These groups are per the Global initiative for chronic obstructive lung disease (GOLD) guideline. The COPD groups are classified based on the severity of symptoms and history of exacerbation in the past 1 year. This study will help to calculate the burden of small airway dysfunction in different COPD groups in patients from India. It will also help how the current recommended treatment by GOLD changes the small airway dysfunction measured in terms of forced oscillation technique, spirometry, and Body plethysmography and whether this small airway dysfunction is related to the quality of life measured in terms of COPD ASSESSMENT TEST(CAT) scoring. |