| CTRI Number |
CTRI/2025/05/087294 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the safety and efficacy of Glycopyrronium / Fluticasone Furoate and Vilanterol dry powder inhaler in the management of Chronic Obstructive Pulmonary Disease in India |
|
Scientific Title of Study
|
An Open Label, Single Arm, Multicentric, Prospective, Phase IV Study to Evaluate the safety and efficacy of FDC Glycopyrronium, Fluticosone Furoate and Vilanterol DPI in Management of COPD Patients in India (ADHERENT STUDY) |
| Trial Acronym |
ADHERENT STUDY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GPL/CT/2024/005/IV, Version 2.0 Dated 24 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumit Bhushan |
| Designation |
Deputy General Manager-Clinical Studies Global Medical Affairs |
| Affiliation |
Glenmark Pharmaceuticals Ltd. |
| Address |
Glenmark Corporate Enclave, BD
Sawant Marg, Chakala, Off WE Highway, Andheri East
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
08800352225 |
| Fax |
|
| Email |
Sumit.Bhushan@glenmarkpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Bhushan |
| Designation |
Deputy General Manager-Clinical Studies Global Medical Affairs |
| Affiliation |
Glenmark Pharmaceuticals Ltd. |
| Address |
Glenmark Corporate Enclave, BD
Sawant Marg, Chakala, Off WE Highway, Andheri East
MAHARASHTRA
400099
India |
| Phone |
08800352225 |
| Fax |
|
| Email |
Sumit.Bhushan@glenmarkpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Singh |
| Designation |
Head Clinical Operations |
| Affiliation |
Clinical Research Network India Pvt Ltd |
| Address |
B-806,807, Advant Navis Business Park #Plot #7, Noida-Greater
Noida Expressway Sector 142, Noida, Delhi-NCR
Gautam Buddha Nagar
UTTAR PRADESH
201305
India |
| Phone |
9695237796 |
| Fax |
|
| Email |
nidhisingh@crnindia.org |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Ltd., Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off
WE Highway, Andheri East Mumbai (Suburban) MAHARASHTRA 400099 India |
|
Primary Sponsor
Modification(s)
|
| Name |
Glenmark Pharmaceuticals Ltd |
| Address |
M/s. Glenmark Pharmaceuticals Ltd., B2, Mahalaxmi Chambers, 22 Bhulabh Mumbai, Maharashtra (India)-400026 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Clinical Research Network India |
B-806 and 807 Advant Navis Business Park Plot No 7 Noida Greater Noida Expressway Sector 142 Noida Delhi NCR Uttar Pradesh 201305 India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deependra Kumar Rai |
All India Institute of Medical Sciences |
Dept. of Pulmonary Medicine, Aurangabad Road Phulwari Sharif Patna, Bihar-801507
Patna
BIHAR |
7783892746
drdeependrakumarrai@gmail.com |
| Dr Anjali R Nath |
Citizen Hospital |
Consultation Room, Department of Respiratory Medicine, Ground Floor, #14,2nd D Main dispensary Road, Kalasipalya, Bangaluru, Karnataka-560002
Bangalore
KARNATAKA |
9995395041
Anjali.madh@gmail.com |
| Dr Bharat Mehrotra |
New Leelamani Hospital Pvt. Ltd |
Consultant
Pulmonologist, 14/116, C-1 Parade Chauraha, Civil lines Kanpur 208001
Kanpur Nagar
UTTAR PRADESH |
7081014787
drbharatmehrotra126@gmail.com |
| Dr Krishna Prasad Anne |
Parnaam Hospital |
Room number 5, Department of Internal Medicine/Diabetic and Renal Management
1-56/6/40 & 41, Pranaam Hospital Lane Mythri Nagar, Madinaguda, Miyapur, Hyderabad, Telangana 500050
Hyderabad
TELANGANA |
9481149281
krishnaprasadanne@gmail.com |
| Dr Sachin Kumar Gupta |
Sarojini Naidu Medical College |
Ground Floor, New Surgical Building, Department of Respiratory Medicine, SN Medical College and Hospital, Moti Katra, Mantola, Agra Uttar Pradesh-282003
Agra
UTTAR PRADESH |
7852858838
guptasachin06@gmail.com |
| Dr Adesh Kumar |
UPUMS, Etawah |
A-102, Type-5 Old
Campus, Uttar Pradesh University of Medical Sciences Saifai, Lachwai
Etawah, Uttar Pradesh
Etawah
UTTAR PRADESH |
9045473801
dradeshkumar1974@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Citizen Hospital Institutional Ethics Committee |
Approved |
| IEC-AIIMS-P |
Approved |
| IEC-Leelamani Hospital |
Approved |
| Institutional Ethics Committee Pranaam Hospitals |
Approved |
| Institutional Ethics Committee S.N Medical |
Submittted/Under Review |
| Institutional Ethics Committee, Uttar Pradesh University of Medical Sciences, Saifai |
Submittted/Under Review |
|
|
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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
VILOR® FG 100 DPI |
FDC of Glycopyrronium 50 mcg, Fluticasone furoate 100 mcg and Vilanterol 25 mcg dry
powder (DPI) for inhalation for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients aged more than or equal to 40 years with diagnosis of COPD as defined by the GOLD Guidelines 2024 Global Initiative for Chronic Obstructive Lung Disease GOLD 2024
2 Post bronchodilator FEV1/FVC less than 0.70 and post-bronchodilator FEV1 more than or equal to 30 percent predicted and less than 80 percent predicted
3 Symptomatic patients receiving ongoing maintenance therapy ICS/LABA or LAMA or LABA/LAMA
4 Patients with exacerbation history in past 1 year.
5 Ability to use DPI independently and correctly in view of the investigator
6 Patient is willing to sign a written informed consent form and agree to follow up on a regular basis as specified in the protocol
|
|
| ExclusionCriteria |
| Details |
1 Documented current diagnosis of asthma
2 Ongoing treatment with Triple therapy (i.e. ICS/LABA/LAMA)
3 Subjects with any life threatening condition or requiring hospitalization for management of current condition
4 Women of childbearing potential are not restricted in this study however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the
product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment
5 Subjects with history of hypersensitivity to the active substance or to any of its excipients of study drug |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety of VILOR® FG 100 DPI in treatment of moderate to severe COPD in Indian population.
Co-Primary: To evaluate the efficacy of VILOR® FG 100 DPI, in terms of lung function improvement in treatment of moderate to severe COPD in Indian population. |
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of VILOR® FG 100 DPI, in terms of patient satisfaction and outcome in treatment of moderate to severe COPD in Indian population. |
12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="187"
Sample Size from India="187"
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 4 |
|
Date of First Enrollment (India)
|
10/06/2025 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study is a prospective open label multicentre single arm interventional study to evaluate the safety and efficacy of VILOR® FG 100 DPI in the management of COPD among Indian patients. Clinical diagnosis of COPD will be as per the standard definition by American Thoracic Society or European Respiratory Society or GOLD 2024. The study would be initiated at each site after review and approval from ethics committee. At screening & baseline the potential patients both male and female more than or equal to 40 years of age with COPD will be screened and enrolled in the study and a written informed consent would be procured before any study related procedures are undertaken. The clinical assessment as per schedule of assessments would be performed throughout the study and Patient will be followed up till end of the study. Treatment and study duration will be 12 weeks. |