| CTRI Number |
CTRI/2023/08/056077 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
28/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Real World Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Real World Evidence in COPD patients. |
|
Scientific Title of Study
|
Real World Evidence on safety and effectiveness of single inhaler triple-therapy
(glycopyrrolate/formoterol fumarate/budesonide) in patients with COPD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Agam Vora |
| Designation |
Medical Director |
| Affiliation |
Vora Clinic |
| Address |
Mehul Building, 302, Lokmanya Tilak Nagar, Maharashtra Nagar, Borivali, Mumbai
Mumbai
MAHARASHTRA
400092
India |
| Phone |
|
| Fax |
|
| Email |
dragamvora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shwetal Sanghvi |
| Designation |
Senior Medical Director |
| Affiliation |
Insignia Communications Pvt. Ltd. |
| Address |
B-405 406 Mittal Commercia Marol Andheri (East)Mumbai
Mumbai
MAHARASHTRA
400059
India |
| Phone |
9820987095 |
| Fax |
|
| Email |
drshwetal@insigniacom.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shwetal Sanghvi |
| Designation |
Senior Medical Director |
| Affiliation |
Insignia Communications Pvt. Ltd. |
| Address |
B-405 406 Mittal Commercia Marol Andheri (East)Mumbai
Mumbai
MAHARASHTRA
400059
India |
| Phone |
9820987095 |
| Fax |
|
| Email |
drshwetal@insigniacom.com |
|
|
Source of Monetary or Material Support
|
| Zydus Healthcare Ltd. India
IB Patel Road, Jay Prakash Nagar, Goregaon East, Mumbai, Maharashta 400063 |
|
|
Primary Sponsor
|
| Name |
Zydus Healthcare Ltd. India |
| Address |
IB Patel road, Jay Prakash Nagar, Goregaon east, Mumbai, Maharashtra 400063 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Agam Vora |
Vora Clinic |
Mehul Building, 302, Lokmanya Tilak Nagar, Maharashtra Nagar, Borivali, Mumbai-400092
Mumbai
MAHARASHTRA |
9820070054
dragamvora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksha-Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Eligible for single inhaler triple therapy (LABA + LAMA + ICS) as per clinician’s discretion
Gives signed written informed consent to participate.
For Female patients
A female is eligible to enter and participate in the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal)
For females with childbearing potential, who agrees for contraception throughout - from Visit 1 (Screening) till 1 month after the final visit)
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Adverse & Serious Adverse events during the study period
Spirometry measures
Change in COPD Assessment Test
Change in modified Medical Research Council Dyspnoea Scale
Change in Clinical COPD Questionnaire
Number of severe exacerbations needing hospitalizations
Use of rescue medications (SABA pMDI) during the study period |
Baseline, 4 weeks & 24 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="705" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2023 |
| Date of Study Completion (India) |
11/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Under Publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is being carried out to understand the safety and effectiveness
of single inhaler triple- therapy Glycopyrrolate (25 mcg) + Formoterol Fumarate
(12 mcg) + Budesonide (400 mcg) [GFB DPI] and Glycopyrrolate (9 mcg) +
Formoterol Fumarate(4.8mcg) +
Budesonide(160mcg)[GFB MDI] -Forglyn plus inhaler in patients with
established clinical history of COPD amongst the Indian population. There is no
data of this combination in real world setting among Indian patients with COPD. |