| CTRI Number |
CTRI/2011/11/002108 [Registered on: 08/11/2011] Trial Registered Retrospectively |
| Last Modified On: |
04/11/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treating shrinking of the lungs by an antibiotic |
|
Scientific Title of Study
|
Evaluation of the role of Matrix metalloproteinases (MMPs) in Idiopathic Pulmonary Fibrosis (IPF) and assessment of clinicoradiological effect of Matrix metalloproteinases inhibition with Doxycycline. |
| 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 |
Institute of Pulmocare & Research |
| Address |
AK 46, Salt Lake.Sector II CB 16, Salt Lake, Sector I. Kolkata WEST BENGAL Kolkata 700091 India |
| Phone |
03323215152 |
| Fax |
03323580424 |
| Email |
parthachest@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Institute of Pulmocare & Research |
| Address |
AK 46, Salt Lake.Sector II CB 16, Salt Lake, Sector I. Kolkata WEST BENGAL Kolkata 700091 India |
| Phone |
03323215152 |
| Fax |
03323580424 |
| Email |
parthachest@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Institute of Pulmocare & Research |
| Address |
AK 46, Salt Lake.Sector II CB 16, Salt Lake, Sector I. Kolkata WEST BENGAL Kolkata 700091 India |
| Phone |
03323215152 |
| Fax |
03323580424 |
| Email |
parthachest@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology, New Delhi,sanc letter :No. BT/PR10759/Med/30/110/2008 |
|
|
Primary Sponsor
|
| Name |
Institute of Pulmocare Research |
| Address |
corresponding address: CB-16, Salt Lake, Kolkata-700064 |
| Type of Sponsor |
Other [Pulmonary research Institute recognized as Scientific and Industrial Research Organization] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Institute of Chemical Biology IICB |
4, Raja S.C. Mullik Road.Jadavpur.Kolkata-700032 |
|
|
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 |
CB-16, Salt lake, Sector I Kolkata WEST BENGAL |
09831003144
parthachest@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 |
Patients suffering from idiopathic pulmonary disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Doxycycline |
It is an antibiotic,present overt 30 yrs in the market.Pt of this study will use 100 mg BD orally after taking food.
Each patient will take doxycycline for at leasr 6 months. |
| Comparator Agent |
Not applicable |
Since it is a single arm trial, no comparator gr will be included in the study. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Informed written consent being given.
• Male and female patients aged 30 to70 years observing the major and minor criteria according to the ATS-ERS guideline.
• IPF diagnosed from pooled expert opinion on HRCT chest.
• No significant occupational history
• FVC more than 40% of prediced
• 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 function
• Feature of chronic congestive cardiac failure (supported by echocardiography)
• Known case of IPF with CVD
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinicoradiological with spirometric chanes. |
Two yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in Matrix metalloproteinases concentration in Bronchoalveolar lavage (BAF). |
Two yrs. |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
28/03/2011 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1.Lung India 2009, vol 26,page 81-85.
2. Indian J Chest Dis Allied Sci 2007;49: 180
Please note that the publication mentioned are background support only for substantiating our project.
They no way are pertain and arise directly out of the trial. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Idiopathic pulmonary fibrosis is a problem of progressive fibrosis of the lung parenchyma without any apparent etiology leading to significant morbidity and premature mortality. The present treatment is limited to the use of corticosteroid and immunosuppressive agents with variable outcome and poor survival expectancy as 30 to 50% at 5 years after the diagnosis. In the process of fibrogenesis, there is a potential role of a class of enzyme called matrix metalloproteinases (MMPs). An imbalance of the MMPs and their tissue inhibitor (TIMPs) can lead to release of growth factors for fibroblast proliferation. Thus MMPs may play an important role in the pathogenesis of IPF and inhibition of MMPs could be a therapeutic target for the disease. The authors have experienced such therapeutic improvement in cases of IPF with doxycycline, an agent known for its MMPs inhibitory property with its use being accepted as MMPs inhibitor for periodontal disease by the FDA, USA. The drug, doxycycline, has been well in use for a prolonged period of time in many conditions without problem of tolerance or toxicity. It is a drug easily available in the market as an antibiotic for over three decades and has got certain established long term use too. The proposed project is to evaluate the role of MMPs in clinicoradiologically diagnosed IPF as per ATS-ERS guideline and also to assess the use of doxycycline in MMPs inhibition in the disease. The entire work can be simply and effectively done by way of observing the changes in different MMPs and TIMPs levels in BAL (broncho alveolar lavage) fluid of IPF patients before and following administration of doxycycline simultaneous to objective documentation of favourable effects on clinical, radiological and physiological status of the patients. |