| CTRI Number |
CTRI/2025/12/099667 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
06/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to determine Safety and Efficacy of Glycopyrronium/Formoterol/Budesonide inhaler [pMDI in Chronic Obstructive Pulmonary Disease (COPD) Treatment. |
|
Scientific Title of Study
|
A Phase IV study to evaluate safety and efficacy of Glycopyrronium/Formoterol/Budesonide (12.5mcg/6mcg/200mcg) triple therapy delivered through pressurized metered dose inhaler [pMDI] in patients with Chronic Obstructive Pulmonary Disease (COPD). |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CP/04/23 Version 01 dated 03/12/2024 |
Protocol Number |
|
|
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 |
Associate Director 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
|
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
Cipla Ltd, 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
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr GMV Kasiram |
Aditya Multispeciality Hospital |
Room no.05- First-Floor Department: Pulmonology, Division: Respiratory Medicine Aditya Multispeciality Hospital, 3rd Line, Gunturvari Thota, Opp, Road RTC Bus, Stand. Kamaraju Scan Centre Road Guntur-522001, Andhra Pradesh-India”
Guntur
ANDHRA PRADESH |
9966083232
kasiram1488@gmail.com |
| Dr Saagar Khadanga |
All India Institute of Medical Sciences |
Faculty Academic Room no-23,UGF, Academic Block Hospital Building, Department of General Medicine, AIIMS-Bhopal, Saket Nagar, Bhopal, Madhya Pradesh - 462024
Bhopal
MADHYA PRADESH |
7771001557
sagar.genmed@aiimsbhopal.edu.in |
| Dr Saurabh Karmakar |
All India Institute of Medical Sciences |
OPD building room no 330 Department of pulmonary medicine AIIMS Patna Aurangabad Road Phulwari Sharif Patna Bihar 801507
Patna
BIHAR |
9839443375
drsaurabhkarmakar@gmail.com |
| Dr Rennis Davis |
Amala Institute of Medical Sciences |
Department of Pulmonary Medicine
Amala Institute of Medical Sciences
Amala Nagar, Thrissur, Kerala, India-680555
Thrissur
KERALA |
9847485785
rennis@rediffmail.com |
| Dr Vipul Khandelwal |
Apex Hospital |
Apex Hospitals Pvt Ltd SP 4 & 6, MIA, Malviya Nagar Jaipur 302017
Jaipur
RAJASTHAN |
9829193517
khandelwalvipul03@gmail.com |
| Dr Vishwanath Gella |
Asian Institute of Gastroenterology |
1-66/AIG/2 to 5, Mindspace Road,
Gachibowli, Hyderabad, Telangana 500032
Hyderabad
TELANGANA |
8978033889
vishwanathgella@gmail.com |
| Dr Jairaj Nair |
Lokmanya Tilak Municipal General Hospital |
Department of respiratory medicine room no 12 1st floor college building Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai 400022
Mumbai
MAHARASHTRA |
8898816660
dr.jairaj.p.nair@gmail.com |
| Dr Gajendra Vikram Singh |
Sarojini Naidu Medical College & Hospital |
Room no 06 Ground Floor
Department Respiratory Medicine
Division Respiratory Medicine
New Surgical building department of respiratory medicine S N Medical College Agra Pin-282003 Uttarpradesh
Agra
UTTAR PRADESH |
9634660312
drsinghgv@gmail.com |
| Dr Aruna Vasireddy |
Siddhartha Medical College and Government General Hospital |
Siddhartha Medical College and Government General Hospital Ring Road Gunadala Vijayawada 520 008
Andhra Pradesh India
Guntur
ANDHRA PRADESH |
9985404485
vasireddyaruna@rediffmail.com |
| Dr Bhavesh Vaghani |
Swaas Chest Allergy & Sleep Clinic |
Room no. 304, 3rd floor,
Department: Respiratory Medicine
Pulse house, near Venus Hospital Lal Darwaja, Katargam road, Surat, Gujrat- 395003
Surat
GUJARAT |
9904262829
dr.bjvaghani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Tilak |
Approved |
| Institutional Ethics Committee, All India Institute of Medical Sciences |
Submittted/Under Review |
| Institutional EthicsCommitteeS.N Medical College |
Approved |
| Institutional Human Ethics Committee All India Institute of Medical Sciences |
Approved |
| InstitutionalEthicsCommittee Amala Institute of Medical Sciences |
Approved |
| InstitutionalEthicsCommittee Asian Institute of Gastroenterology |
Approved |
| InstitutionalEthicsCommitteeAdityaMultiSpecialityHospital |
Approved |
| InstitutionalEthicsCommitteeApexHospitals |
Approved |
| InstitutionalEthicsCommitteeSMCandGGH |
Approved |
| SIMS 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 |
FDC of Glycopyrronium/Formoterol/Budesonide (12.5mcg/6mcg/200mcg) inhaler [pMDI] |
Two inhalations twice a daily for 12 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
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.4. Post-bronchodilator FEV1 greater than or equal to 30 percent and less than or equal to 80 percent of the predicted normal value.5. Post-bronchodilator FEV1/FVC ratio of less than 0.7.6. Subjects with CAT score greater than or equal to 10.7. Current or ex-smoker of at least 10 pack years of cigarette/ bidi smoking or subjects who had exposure to noxious stimuli. |
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity to glycopyrronium or formoterol or budesonide or any of its components.
2. Subjects receiving 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. Subjects requiring oxygen therapy (at least 12 hours daily) in past 4 weeks from screening.
6. Clinically significant ECG abnormality (QTcF greater than 500msec) at screening.
7. History of clinically significant bladder neck obstruction or urinary retention
8. History of uncontrolled glaucoma.
9. History of uncontrolled diabetes mellitus.
10. Female who is pregnant or lactating or planning to be pregnant
11. Woman of childbearing potential who is unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator
|
|
|
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 (TEAE). |
Screening, Baseline, Week 6 and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change in CAT score at week 6 and week 12 from baseline.
Mean change in through FEV1 and FVC at week 12 from baseline. |
Total 3 Timepoint
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)
|
22/01/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
All patients willing to participate in the study will be required to give a written informed consent in the language understood by him/her. Patients will require a confirmed documented diagnosis of COPD through spirometry and satisfying the eligibility criteria. Patients will be enrolled. Safety and efficacy assessments will be performed at screening, baseline, week 6 and week 12. |