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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  
Status 
Not Applicable 
 
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. 
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