| 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
|
|
|
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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