| CTRI Number |
CTRI/2025/02/079897 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treating COPD-PH without RHC |
|
Scientific Title of Study
|
Validation of a novel algorithm for treating COPD-PH patients with tadalafil without invasive procedure. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| COPD-PH/IPCR/11/2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Institute of Pulmocare and Research |
| Address |
DG-8, Action area-1, New Town, Kolkata-700156
DG-8, Action area-1, New Town, Kolkata-700156
Kolkata
WEST BENGAL
700156
India |
| Phone |
09831003144 |
| Fax |
|
| Email |
ipcr_india@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Institute of Pulmocare and Research |
| Address |
DG-8, Action area-1, New Town, Kolkata-700156
DG-8, Action area-1, New Town, Kolkata-700156
Kolkata
WEST BENGAL
700156
India |
| Phone |
09831003144 |
| Fax |
|
| Email |
ipcr_india@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Institute of Pulmocare and Research |
| Address |
DG-8, Action area-1, New Town, Kolkata-700156
DG-8, Action area-1, New Town, Kolkata-700156
Kolkata
WEST BENGAL
700156
India |
| Phone |
09831003144 |
| Fax |
|
| Email |
ipcr_india@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research.
V. Ramalingaswami Bhawan, PO Box No. 4911 Ansari Nagar, New Delhi - 110029, India, |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
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 and Research |
DG-8, Action area-1, New Town, Kolkata-700156
Kolkata
WEST BENGAL |
09831003144
ipcr_india@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Institute of Pulmocare and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard pharmacotherapy of COPD as LABA- LAMA±ICS uniformly, with treatment of comorbidities ad uniform effort of rehabilitation including long term oxygen therapy. |
Patients subjects where anti-PH therapy (i.e. vasodilators) will not be included. |
| Intervention |
Treatment with comparator agent and add on tadalafil |
10 mg a day to start with and gradually increase the dose to 20 mg a day and to continue. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
These patients shall have to be on optimal standard management of COPD/ in the
underlying disease and the existing co-morbid conditions.
Patients with 18 years to 75 years in both sexes.
A proper written consent will be taken before including the patients in the study.
|
|
| ExclusionCriteria |
| Details |
1) Very sick patients.
2) Features of significant RV failure: clinical and echocardiographic (should be treated under admission and direct supervision).
3) LV systolic dysfunction.
4) Inability to perform 6 MWT/ 2-CT
5) Grossly oxygen dependence
6) Associated other diseases (remaining untreated) that can cause PH
7) History of exacerbation in the preceding 4 weeks of screening and 6 weeks before randomization.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome of the study is to determine the change in 6MWD in the patients over the study period |
The primary outcome for each patient would be specifically assessed periodically at baseline, after 3 months, 6 months, 9 months and 12 months respectively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preparation for exploratory research: To preserve serum and DNA for future research. |
8 months (Total)
4 months for 1st year, 4 months for 2nd year. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Summary of the proposal research:
Background: Mild to moderate pulmonary hypertension (PH) in advanced COPD or COPD-PH is common and it influences the quality of life and the survival prospect adversely. Despite the availability of pulmonary vasodilators for the treatment of PH, there is no guideline for treating the patients of COPD-PH due to lack of good evidence in favor of treatment. Novelty: The study attempts to validate a novel algorithm endorsed by the institute, for the diagnosis and treatment without invasive interventions. The algorithm comprises of clinical, radiological and echocardiographic assessments indicated for the evaluation of PH. Objective: The primary objective of the study is to validate a novel algorithm for treating COPD-PH without Right Heart Catheterization (RHC). Methods: The research includes screening of COPD patients for presence of PH through an algorithm of evaluation of patients from a referral pulmonary OPD services. Further, the selection of subjects will be done based on a specified inclusion and exclusion criteria. The qualified candidates will be further randomized to receive treatment with pulmonary vasodilators (Sildenafil/Tadalafil) on a protocol of prospective open randomized fashion for one year. The impact will be measured on a defined measurements functional, lung functional, quality-of life, and echocardiographic assessment of the impact of medication and recording of the adverse events. The data will be analyzed and presented. Expected Outcomes: The research is likely to help opening up a way forward to treat the COPD-PH patients and avert a lot of mortality and morbidity. |