| CTRI Number |
CTRI/2011/091/000182 [Registered on: 03/03/2011] |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical study to evaluate efficacy and safety of inhaled corticosteroids in mild to moderate cases of Chronic Obstructive Pulmonary Disease |
|
Scientific Title of Study
|
A randomized double blind parallel group comparative study to evaluate efficacy and safety of triplet combination (Ciclosonide, Tiotropium bromide and Formoterol) and dual combination (Tiotropium bromide and Formoterol) in mild to moderate cases of Chronic Obstructive Pulmonary Disease |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| U1111-1128-8591 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr CB Tripathi |
| Designation |
Professor and Head |
| Affiliation |
GMC BHAVNAGAR |
| Address |
Dept. of Pharmacology, Govt. Medical College
Behind S.T. Bus Stand, Jail Road
Bhavnagar
GUJARAT
364001
India |
| Phone |
09825951678 |
| Fax |
02782422011 |
| Email |
cbrtripathi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr CB Tripathi |
| Designation |
Professor and Head |
| Affiliation |
GMC BHAVNAGAR |
| Address |
Dept. of Pharmacology, Govt. Medical College
Behind S.T. Bus Stand, Jail Road
Bhavnagar
GUJARAT
364001
India |
| Phone |
09825951678 |
| Fax |
02782422011 |
| Email |
cbrtripathi@yahoo.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr CB Tripathi |
| Designation |
Professor and Head |
| Affiliation |
GMC BHAVNAGAR |
| Address |
Dept. of Pharmacology, Govt. Medical College
Behind S.T. Bus Stand, Jail Road
Bhavnagar
GUJARAT
364001
India |
| Phone |
09825951678 |
| Fax |
02782422011 |
| Email |
cbrtripathi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Research project grant of Government of Gujarat |
|
Primary Sponsor
Modification(s)
|
| Name |
Research project grant of Government of Gujarat |
| Address |
The Commissioner of Health,
Health, Medical Services and Medical Education (ME),
Civil Hospital, Gandhinagar. (Gujarat). |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. C.B. Tripathi |
Sir Takhtsinhji General Hospital, Bhavnagar, Gujarat |
Dept. of Pharmacology, Govt. Medical College,Behind S.T. Bus Stand, Jail Road-364001
Bhavnagar
GUJARAT |
09825951678
02782422011
cbrtripathi@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) Govt. Medical College, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Chronic Obstructive Pulmonary Disease, (1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Metered dose inhaler containing Tiotropium Bromide 9 mcg and Formoterol 6 mcg |
Drug will be given one puff once a day for 3 months |
| Intervention |
Metered dose inhaler containing Ciclosonide 200 mcg, Tiotropium Bromide 9 mcg and Formoterol 6 mcg |
Drug will be given one puff once a day for 3 months |
|
Inclusion Criteria
Modification(s)
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age between 35 to 70 years of either sex
Clinically diagnosed mild to moderate COPD as per GOLD guideline (FEV1 more than 50 FEV1 and FVC ratio less than 0.7)
Ability to give written informed consent
Smokers and ex-smokers more and equal to 10 pack per years
|
|
| ExclusionCriteria |
| Details |
Patients on oral steroid
History Of significant illness of other system especially cardiovascular system
History of exacerbation in run in period
Patients having other serious respiratory illness ( tuberculosis asthma) other than COPD
History of long acting antihistaminic within 1 week
History of Hypersensitivity to study medications
Contraindication to six minute walk test
Do not give informed consent
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function test (FEV1 and FVC) |
Prospective |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Six minute walk distance (6MWD) |
Prospective |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
13/01/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There will be 70 patients in the study. This is randomized, double blind, active control, parallel group, single centre, study to evaluate efficacy and safety of triplet combination (Ciclosonide, Tiotropium bromide and Formoterol) and dual combination (Tiotropium bromide and Formoterol) in mild to moderate cases of Chronic Obstructive Pulmonary Disease. It will be done in India. Primary outcome measures will be pulmonary function test (FEV1 and FVC) at one month interval for three months.
Secondary outcome measures will be exercise tolerance (Six minute walk distance) at one month interval for three months.
|