| CTRI Number |
CTRI/2026/02/102817 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study to determine the Safety and efficacy of FDC of Glycopyrronium 12.5 mcg & Formoterol Fumarate 6 mcg Inhaler in patients with Chronic Obstructive Pulmonary Disease |
|
Scientific Title of Study
|
A Phase IV study to evaluate safety and efficacy of FDC of Glycopyrronium 12.5 mcg & Formoterol Fumarate 6 mcg Inhaler in patients with Chronic Obstructive Pulmonary Disease |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CP/07/25 Version 01 Date 23/05/2025 |
Protocol Number |
| CT Permission no FDC/CT/25/000057 dated 27 Aug 2025 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaideep Gogtay |
| Designation |
Global Chief Medical Officer |
| Affiliation |
Cipla Limited |
| Address |
Cipla Ltd, Dept: Medical Services, Division Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai- 400008 Maharashtra, India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223025145 |
| Fax |
|
| Email |
jgogtay@cipla.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Sawant |
| Designation |
Head- Clinical Trials |
| Affiliation |
Cipla Limited |
| Address |
Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai- 400008 Maharashtra, India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223025006 |
| Fax |
|
| Email |
sandesh.sawant3@cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Abhijit Vaidya |
| Designation |
Project Lead, Clinical Trials |
| Affiliation |
Cipla Limited |
| Address |
Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai- 400008 Maharashtra, India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223025623 |
| Fax |
|
| Email |
abhijit.vaidya@cipla.com |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd, 289 Bellasis Road, Mumbai Central, Mumbai, Maharashtra, 400008, India |
|
|
Primary Sponsor
|
| Name |
Cipla Limited |
| Address |
289 Bellasis Road, Mumbai Central, Mumbai, Maharashtra, 400008, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Goli M Venata Kasiram |
Aditya Multi speciality hospital |
1st floor, room no. 05, pulmonary department Aditya Multi speciality hospital, 13-3-52, 3rd Ln, Gunturvari Thota, Kothapeta, besides peoples trauma, Guntur, Andhra Pradesh 522001
Guntur
ANDHRA PRADESH |
9966083232
kasiram1488@gmail.com |
| Dr Sajal De |
All India Institute of Medical Sciences, Raipur |
Room No. PM 104 1st floor, D Block All India Institute of Medical Sciences ,Gate No 1, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH |
9340274642
sajalde@yahoo.com |
| Dr Sudheer D |
Chest And Communicable Disease Hospital |
Chest and Communicable Disease Hospital Gorantla, Guntur, Andhra Pradesh 522034
Guntur
ANDHRA PRADESH |
8919069428
dsudheer.dr@gmail.com |
| Dr Suhas Bardapurkar |
Galaxy Super speciality hospital |
Galaxy Super speciality hospital, floor no 1, OPD no. 08, Agnihotra Chowk, Garkheda Area, Ulkanagari, Chhatrapati Sambhaji Nagar, Maharashtra 431001
Aurangabad
MAHARASHTRA |
9423150213
drsuhas.pulmo@gmail.com |
| Dr Sanjay Verma |
Ganesh Shankar Vidyarthi Memorial Medical College |
Dr Murarilal Chest Hospital, Ground floor, room no 09, Ganesh Shankar Vidyarthi Memorial Medical College, Swaroop Nagar, Kanpur, Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH |
9415075458
vermasanjayk0@gmail.com |
| Dr Ankit Kumar |
King Georges Medical University - Lucknow |
Department of Respiratory Medicine KGMU Lucknow Uttar
Pradesh 226003
Lucknow
UTTAR PRADESH |
9305015816
ankyr007@gmail.com |
| Dr Rajkumar Nikalje |
Punawale Multispeciality Hospital |
ground floor, OPD room 01, Jambhe Road, Near Khandoba Mandir, Punawale, Pune Maharashatra, 411033 India
Pune
MAHARASHTRA |
9028560535
rajkumar.nikalje23@gmail.com |
| Dr Surendra Kumar |
S P Medical College & A.G. of Hospitals |
S P Medical College & A.G. of Hospitals, Department of Medicine, Near Medicine ICU Bikaner, Rajasthan 334001,India
Bikaner
RAJASTHAN |
9414604192
drsurendrakumar@rediffmail.com |
| Dr Abhijit Telkhade |
Shree Ashirwad Hospital |
Shree Ashirwad Hospital C-3, Shree Complex, Opp. To Mahavir Nagar, Manpada Road, Dombivli east 421201
Thane
MAHARASHTRA |
9022434787
abhijittelkhade8@gmail.com |
| Dr Vivek Vardhan |
Swasa Hospital India Pvt Ltd |
Swasa Hospital India Pvt LtdBesides Narayanguda Flyover Next to Taj Mahal Hotel Narayanguda Hyderabad 500029
Hyderabad
TELANGANA |
9502077555
vivekswasa@gmail.com |
| Dr Nana Kunjir |
Vishwaraj Hospital |
OPD No. 6, ground floor, department of pulmonology, Vishwaraj Hospital, Ground Floor, Gate no. 499, Kadamvakvasti, Near Loni Railway Station, Loni Kalbhor, Solapur – Pune Hwy, Pune Maharashatra 412201
Pune
MAHARASHTRA |
9962257627
drnana.kunjir@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committee (Dr. Abhijit Telkhade) |
Approved |
| Aurangabad Health Care and Research LLP IEC (Dr Suhas Bardapurkar) |
Approved |
| Bioethics Independent Ethics Committee (Dr. Vivek Vardhan) |
Approved |
| Ethics Committee GSVM medical College Kanpur (Dr Sanjay Verma) |
Approved |
| Ethics Committee S.P. Medical College, Bikaner (Dr Surendra Kumar) |
Approved |
| IEC Aditya Multi speciality Hospital (Dr GMV Kasiram)) |
Approved |
| IEC, Maeers Vishwaraj Hospital (Dr Nana Kunjir) |
Approved |
| Institute Ethics Committee, AIIMS Raipur (Dr Sajal De) |
Submittted/Under Review |
| Institutional ethics committee GMC and GGH (Dr. Sudheer D) |
Approved |
| Institutional Ethics Committee King Georges Medical University (Dr Ankit Kumar) |
Approved |
| Punawale Hospital Ethics Committee (Dr. Rajkumar Nikalje) |
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 |
FDC of Glycopyrronium & Formoterol Fumarate Inhaler (12.5 mcg + 6 mcg) |
Metered Dose Inhaler, two inhalations twice daily (Morning and Evening) for 12 weeks |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 A voluntarily given written, signed, and dated informed consent from subjects
2 Subjects of either gender 40 years or above
3 Subjects with a documented history of COPD based on spirogram and in compliance to the GOLD 2025 guidelines
4 Subjects with Post-bronchodilator FEV1 greater than or equal to 30% of the predicted normal value and Post-bronchodilator FEV1/FVC ratio of less than 0.7
5 Subjects with CAT score greater than or equal to 10
6 Subject with current or past cigarette smoking history or exposure to noxious stimuli
7 Subject should be able to correctly use the pressurised metered dose inhaler pMDI
|
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity to glycopyrronium or formoterol fumarate or any of its components.
2. Subjects receiving dual therapy (LABA + LAMA), triple therapy (ICS+LABA+LAMA) (fixed dose or free combination) for COPD within 3 months from screening.
3. Subjects with hospitalization required for severe exacerbation or any serious condition within past 12 weeks from screening.
4. Subjects requiring oral/parenteral corticosteroids within past 4 weeks from screening.
5. Clinically significant neurologic, cardiovascular, hepatic, renal, endocrine, pulmonary (post-tuberculosis fibrosis, pulmonary fibrotic disease, pulmonary arterial hypertension), hematologic, psychiatric, or other medical illness that will interfere with participation in this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adverse events including Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs). |
Baseline, Week 6 and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in CAT score at week 6 and week 12 from baseline |
Week 6 and week 12 |
| Mean change in trough FVC at week 6 and week 12 from baseline |
Week 6 and week 12 |
| Mean change in COPD and Asthma Sleep Impact Scale (CASIS) score at week 6 and week 12 from baseline |
Week 6 and week 12 |
| Mean change in trough FEV1 at week 6 and week 12 from baseline |
Week 6 and week 12 |
| Proportion of patients with reduction in mMRC grade at week 6 and week 12 from baseline |
Week 6 and week 12 |
|
|
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 4 |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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="1"
Months="0"
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
|
A Phase IV open label, prospective, non-comparative, multicentre, interventional study to evaluate safety and efficacy of FDC of Glycopyrronium & Formoterol Fumarate Inhaler (12.5 mcg + 6 mcg) in patients with Chronic Obstructive Pulmonary Disease (COPD). The study will be conducted in 100 participants in India. The study will primarily evaluate the safety and tolerability of FDC of Glycopyrronium & Formoterol Fumarate Inhaler through assessment of adverse events including Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs). Additionally the study will also evaluate efficacy of the formulation as maintenance treatment in patients with COPD |