| CTRI Number |
CTRI/2011/07/001897 [Registered on: 18/07/2011] Trial Registered Retrospectively |
| Last Modified On: |
18/07/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Treating chronic cough and breathlessness by an antibiotic |
|
Scientific Title of Study
|
An open prospective real world observational study of use of long term doxycycline in chronic obstructive pulmonary disease (COPD). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Consultant |
| Address |
Institute of Pulmocare and Research
AK-46, Salt Lake
Kolkata
WEST BENGAL
700091
India |
| Phone |
03323212919 |
| Fax |
03323580424 |
| Email |
parthachest@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Consultant |
| Address |
Institute of Pulmocare and Research
AK-46, Salt Lake
Kolkata
WEST BENGAL
700091
India |
| Phone |
03323212919 |
| Fax |
03323580424 |
| Email |
parthachest@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Consultant |
| Address |
Institute of Pulmocare and Research
AK-46, Salt Lake
Kolkata
WEST BENGAL
700091
India |
| Phone |
03323212919 |
| Fax |
03323580424 |
| Email |
parthachest@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Pulmocare and Research |
|
|
Primary Sponsor
|
| Name |
Dr Parthasarathi Bhattacharyya |
| Address |
AK-46, Salt Lake.Kolkata-700091 |
| Type of Sponsor |
Other [Non Government Pulmonary Research Institute] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institute of Pulmocare and Research |
Off Address: CB-16, Salt Lake.Kolkata-700064 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parthasarathi Bhattacharyya |
Institute of Pulmocare& Research |
Off Address: CB-16, Salt lake. Kolkata-700064
Kolkata
WEST BENGAL |
03323580424
pathachest@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Obstructive Pulmonary Disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Doxycycline |
It is an antibiotic. We want to see its long term use (100 mg BD, orally) on the lung function of a small no of advanced COPD patients.Long term therapy is meant as continuation of the drug (Doxycycline) for at least 6 months. The maximum duration is not defined. The Rx may be continued for longer duration (may be in years) provided the patient shows improvement in follow-up without any side effects.
|
| Comparator Agent |
No comparator |
Not applicable in this study |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Informed written consent being given
Male and female patients aged 40-70 years
Has been on optimum pharmacotherapy for COPD
COPD severity diagnosed by GOLD criteria
No significant occupational history
FEVI 30-50%predicted; FEVI/FVC less than70%
Non pregnant, non lactating woman
|
|
| ExclusionCriteria |
| Details |
History of exacerbation in past 1 month
History of Doxy allergy
Having any obvious contraindication for Doxycycline
Unable to meet the demand of the protocol for any reason
Significant abnormality in liver or renal or other organ function
Feature of chronic congestive cardiac failure (supported by echocardiography
any other concomitant lung disease (significant as per PI)
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in both pre and post bronchodilator FEVI |
As and when atleast 30 patients will take doxycycline for at least 6 months and shall have at least one repeat spirometry done in a real world situation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2009 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Sending to Indian Journal of Medical Research.(IJMR_253_11) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this open,real world prospective observation we wish to see the effect of long term use of oral doxycycline (100 mg BD)on the lung function of a cohort of stable advanced COPD patients. The follow up and the performance of the repeat spirometry were left totally to the patients convenience as it actually happens in real world practice.
We have the initial data being collected from 28 patients of COPD (Mean FEVI 0.82±0.32 post bronchodialator ) shows improvement in FEVI to a of about 90 ml in post bronchodialator.
They received the medication for about 735±442 days.
This is no way a conventional drug trial .A molecule available over 30 yrs in the market with well known details of tolerance of long term use in other indications has been used in a real world practice to observe its effects on lung function of COPD patients. |