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CTRI Number  CTRI/2011/11/002150 [Registered on: 21/11/2011] Trial Registered Retrospectively
Last Modified On: 19/11/2011
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Treating shrinking of lungs  
Scientific Title of Study   Evaluation of the role of Doxycycline in Interstitial Lung Disease (ILD) /Diffuse Parenchymal Lung Disease (DPLD) in a real world observation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parthasarathi Bhattacharyya 
Designation  Principal Investigator 
Affiliation  Institute of Pulmocare & Research 
Address  AK 46 Salt Lake
CB 16 Salt Lake Kolkata 700064
Kolkata
WEST BENGAL
Kolkata 700091
India 
Phone  03323215152  
Fax  03323580424  
Email  parthachest@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Parthasarathi Bhattacharyya 
Designation  Principal Investigator 
Affiliation  Institute of Pulmocare & Research 
Address  AK 46 Salt Lake
CB 16 Salt Lake Kolkata 700064
Kolkata
WEST BENGAL
Kolkata 700091
India 
Phone  03323215152  
Fax  03323580424  
Email  parthachest@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Parthasarathi Bhattacharyya 
Designation  Principal Investigator 
Affiliation  Institute of Pulmocare & Research 
Address  AK 46 Salt Lake
CB 16 Salt Lake Kolkata 700064
Kolkata
WEST BENGAL
Kolkata 700091
India 
Phone  03323215152  
Fax  03323580424  
Email  parthachest@yahoo.com  
 
Source of Monetary or Material Support  
Institute of Pulmocare & Research 
 
Primary Sponsor  
Name  Institute of Pulmocare Research 
Address  Off address: CB-16, Salt Lake, Kolkata-700064. 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Institute of Pulmocare 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 Department: Clinical Research
Kolkata
WEST BENGAL 
9831003144
03323580424
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  Interstitial lung disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Doxycycline antibiotic  It is generally used 100 mg twice daily orally after one hour of taking meals. It is used at least for 6 months. 
Comparator Agent  No comparator is needed for this work.  Not applicable for this trialas it is a single arm trial. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Willing to give written informed consent

2. Clinically suspected patients with ILDs with the diagnosis being substantiated through chest X-ray(PA) and HRCT chest.  
 
ExclusionCriteria 
Details  1.History of exacerbation in past 1 month

2.History of Doxy allergy

3.Having any obvious contraindication for Doxycycline

4.Unable to meet the demand of the protocol for any reason

5.Significant abnormality in liver or renal function

6. Feature of chronic congestive cardiac failure (supported by echocardiography)

7.Known case of Idiopathic pulmonary disease with cardiovascular disease

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
At least no detoriation than before in subjective wellbeing of the patient and clinicoradiological and ±FVC changes.  Between 12 weeks and 6 months after starting doxycycline with repeat spirometry. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Not applicable 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/05/2008 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

ILD is a group of heterogeneous diseases from different etiologies with a common denominator of diffuse parenchymal involvement and destruction by predominant fibrosis. Several types of diseases are listed such as idiopathic interstitial pneumonias (IIP), collagen vascular diseases, occupational lung diseases, sarcoidosis etc apart from a lot of other relatively rare diseases Idiopathic pulmonary fibrosis (IPF), the most common variant of idiopathic interstitial pneumonias is studied most extensively amongst the ILDs. The mechanism of development of fibrosis in ILDs is not well elaborated in all the different etiological subcategories.

The role of MMPs appear critical in IPF and probably in other categories of IIPs and ILDs.Doxycycline is a non specific MMPs inhibitor and has shown beneficial effects in IPF with demonstration of reduction in the MMPs level in BALF .Though not studied, it is likely that MMPs plays a significant role in other varieties of DPLDs-where administration of  doxycycline in similar fashion may have a therapeutic role

The proposed study will be a real world single arm prospective observational trial.  The selection criteria is not very strict as it prevails in existing practice of a physician in a developing country and the investigations will be done as far as possible to an extent the patient is willing or can afford to pay for in accordance with the prevailing circumstances.

Similarly, like a conventional trial there will be no fixed protocol for follow ups, though a regular requirement of review and monitoring will be suggested to each patient. Again, the volunteers will be requested to report for suspected adverse reaction, if any than looking such things on a stringent fashion as being done in a formal drug trial.

The evaluation process also will be far from ideal as is followed in a drug trial. However, it will be objective as far as possible in the available situation and the practice style.

All efforts will be exerted to extract the best possible information from the available records. The physician though not blinded will have full access into the record and power to modify the treatment as and when he or she feels it necessary. The etiological assessment and the severity evaluation will be done at the point of data collection only.

 

 
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