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CTRI Number  CTRI/2025/12/099427 [Registered on: 18/12/2025] Trial Registered Prospectively
Last Modified On: 14/07/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study of a Triple drug-Combination Inhaler for COPD patients. 
Scientific Title of Study   The Safety and Effectiveness of Fixed dose combination of Budesonide, Glycopyrronium and Formoterol Fumarate Dihydrate, 200mcg/12.5mcg/6mcg) Metered Dose Inhaler (MDI) for maintenance treatment of Chronic Obstructive Pulmonary Disease patients: A Multicenter, Prospective, Open Label, Single arm, Phase IV Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CE-25-02 (Version 02 Dated 03 SEP 25)  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayesh Sanmukhani 
Designation  Medical Director 
Affiliation  Clinexcel Research 
Address  297, SoBo Centre, South Bopal, Ahmedabad, Gujarat 380058

Ahmadabad
GUJARAT
380058
India 
Phone  7600012192  
Fax    
Email  drjayesh@clinexcelresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayesh Sanmukhani 
Designation  Medical Director 
Affiliation  Clinexcel Research 
Address  297, SoBo Centre, South Bopal, Ahmedabad, Gujarat 380058


GUJARAT
380058
India 
Phone  7600012192  
Fax    
Email  drjayesh@clinexcelresearch.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayesh Sanmukhani 
Designation  Medical Director 
Affiliation  Clinexcel Research 
Address  297, SoBo Centre, South Bopal, Ahmedabad, Gujarat 380058


GUJARAT
380058
India 
Phone  7600012192  
Fax    
Email  drjayesh@clinexcelresearch.com  
 
Source of Monetary or Material Support  
Lupin Limited,3rd Floor, Kalpataru Inspire, Off. Western Expressway Highway, Santacruz (East), Mumbai 400 055, India 
 
Primary Sponsor  
Name  Lupin Limited  
Address  3rd Floor, Kalpataru Inspire, Off. Western Expressway Highway, Santacruz (East), Mumbai 400 055, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chintan Patel  Aatman Hospital  Aatman Hospital, 5 Anveshan Row House, Bopal Gam BRTS, Bopal-Ghuma road, Bopal, Ahmedabad- 380058
Ahmadabad
GUJARAT 		 9825182251

cr.aatman@gmail.com 
Dr Sandip Dandin  Belagavi Institute of Medical Sciences  Belagavi Institute of Medical Sciences, Dr. BR Ambedkar Road, Sadashiv Nagar, Belagavi
Belgaum
KARNATAKA 		 9902044866

drsandeepdandin@gmail.com 
Dr SSVV Narasinga Rao  Government Medical College and Government General Hospital   Government Medical College and Government General Hospital, Shanti Nagar Colony, Balaga, Srikakulam, Andhra Pradesh 532 001, India
Srikakulam
ANDHRA PRADESH 		 8942279000
-
drnarasingaraossvv@yahoo.com  
Dr Sanjay Verma  GSVM Medical College  Department of Respiratory Medicine, GSVM Medical college, Swaroop Nagar, Kanpur, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH 		 9415075458

drskverma78@rediffmail.com 
Dr Piyush Arora  Jawahar lal Nehru Medical college  Jawahar lal Nehru Medical college, Kalabagh, Ajmer- 305001, Rajasthan
Ajmer
RAJASTHAN 		 7737258659

doctor.piyusharora@gmail.com 
Dr Sarat Kumar Behera  KIDS Hospital  Department of TB and Chest, KIDS Hospital, 1120, Dumduma, Bhubaneshwar 751019
Khordha
ORISSA 		 9438554039

drsarat2010@rediffmail.com 
Dr Ravi Kopula  Medigene Multispeciality Hospital  OP Chamber, 1st Floor, Medigene Multispeciality Hospital Pvt. Ltd, D.NO. 43-9-201, Sy No. 321-323, Railway New Colony, Visakhapatnam- 530016
Visakhapatnam
ANDHRA PRADESH 		 7995881980

bsrinivas_r@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
ACEAS Independent Ethics committee  Approved 
Institutional Ethics Committee Government General Hospital Srikakulam  Approved 
Institutional Ethics Committee Jawahar Lal Nehru Medical college  Approved 
KIDS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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  Budesonide, Glycopyrronium and Formoterol Fumarate Dihydrate, 200mcg/12.5mcg/6mcg  Two actuation twice daily for 12 weeks 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients of either gender, aged 18 years or above.
2. Patients diagnosed with COPD according to the GOLD 2025 guidelines.
3. COPD Assessment Test (CAT) score more than or equal to 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 6 weeks at the time of screening.
4. Patients willing to provide written informed consent, literate enough to fill the diary card, and comply with the protocol requirements. 
 
ExclusionCriteria 
Details  1.Patients with known hypersensitivity to Budesonide, Glycopyronium and Formoterol, other beta 2 agonists, other anti-muscarinic agents or other corticosteroids.

2.Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.

3.Patients with known alpha 1 antitrypsin deficiency

4.COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period

5.Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period

6.Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period

7.Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention

8.Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy

9.Patients with hepatic dysfunction (Serum Glutamic Oxaloacetic Transaminase (SGOT) & Serum Glutamic Pyruvic Transaminase (SGPT) more than or equal to 3 times Upper Normal Limit) or renal dysfunction (serum creatinine more than or equal to 2.5 mg/dl) at screening

10.Patients with continuing history of alcohol and/or drug abuse

11.Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception

12.Participation in another clinical trial in the past 3 months

13.Any other reason for which the investigator feels that the patient should not participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients with adverse events (AEs) & Incidence rate of AE (Serious/ Non Serious , Expected / Non-expected , Related / Non Related)  Baseline to end of study 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in CAT score  Baseline vs at week 6 and Week 12 
Proportion of subjects with improvement in mMRC score  Baseline vs at week 6 and Week 12 
Proportion of patients with COPD exacerbations  Basline to End of study 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   29/12/2025 
Date of Study Completion (India) 28/05/2026 
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)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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)  		 This was a multicenter, prospective, open-label, single-arm, Phase IV clinical study conducted to evaluate the safety and effectiveness of the fixed-dose combination of Budesonide, Glycopyrronium and Formoterol Fumarate Dihydrate (200 mcg/12.5 mcg/6 mcg) Metered Dose Inhaler (MDI) as maintenance treatment in patients with Chronic Obstructive Pulmonary Disease (COPD). A total of 200 patients were enrolled and received treatment for 12 weeks. The primary objective of the study was to assess the safety of the study medication in patients with COPD, while the secondary objective was to evaluate its effectiveness. 
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