CTRI/2025/12/099201 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On:
16/03/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A study on efficacy and safety of revefenacin nebulization versus tiotropium dry powder inhaler in chronic obstructive pulmonary disease (COPD)
Scientific Title of Study
A randomized, open label, active-controlled, parallel-group, multicenter, Phase III study to evaluate efficacy, safety, and tolerability of Revefenacin inhalationsolution 175 mcg versus Tiotropium dry powder for inhalation 18 mcg in subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CP/07/24 V 01 dated 16/12/2024 Amendment 01 dated 20/06/2025
Protocol Number
CT Permission No. CT/ND/07/2025 dated 05/05/2025
DCGI
CT Permission Protocol Amnd 01 dated 19/08/2025
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
Department and Division Respiratory medicine, Respiratory OPD,Maratha Section Near Jijamata Udyan Ulhasnagar ThaneMaharashtra - 421004 Thane MAHARASHTRA
9822017445
writetoshrikant@rediffmail.com
Dr SanthalingamBalamurugan
ACS Medical College and Hospital
Poonamalli Highway Vellapanchavadi, Tiruvallur Tamil Nadu - 600077 Chennai TAMIL NADU
9600002646
dr.s.bala@gmail.com
Dr Anant Mohan
All India Institute of Medical Sciences (New Delhi)
Department of Pulmonary Medicine, Ansari Nagar, PIN - 110029 New Delhi DELHI
9810048204
anantmohan@yahoo.com
Dr Srikant Malegaokar
All India Institute of MedicalSciences(AIIMS), Nagpur
Department and Devision of Pulmonary Medicine, Plot No 02,Sector 20, MIHAN, Nagpur, Sumthana, Maharashtra - 41108. Nagpur MAHARASHTRA
9582273519
kmsrikant@gmail.com
Dr Vipul Khandelwal
Apex Hospitals Pvt. Ltd
Department and Division Medicine, Room No P4 & 6, "ApexHospitals Pvt. Ltd S P4 & 6, Malviya Industrial Area, MalviyaNagar Jaipur, Rajasthan 302017 Jaipur RAJASTHAN
9829193517
dr.vipul@yahoo.com
Dr Shreehas Bardapurkar
Galaxy Superspeciality Hospital,
Agnihotra Chowk, Opp. to Punjab National Bank, Ulka Nagari, Aurangabad, Maharashtra 43 I 001 India Aurangabad MAHARASHTRA
9405912791
dr.shreehas.pulmo@gmail.com
Dr Mahesh Vaghani
Global Hospital
Fourth Floor, OPD room No-1 and 4, Beside Navjivan, SarthanaJakatnaka, Surat, Gujarat – 395006 Surat GUJARAT
9825433984
globalhospitalcr@gmail.com
Dr Ranjith V
K R Hospital
Department and devision of Medicine, Ground floor OPDm K RHospital attached to Mysore Medical College and ResearchInstitute, Irwin Road Mysore 570001 Mysore KARNATAKA
9448188588
ranjithvmmcri@gmail.com
Dr Himanshu Pophale
Kothrud Hospital
Department of pulmonary Medicine, Medicine Division, PilmonaryOPD, 1st floor, Opp. Hill View Park, (Metro Car Depot), PaudRoad, Kothrud, Pune, Maharashtra 411038 Pune MAHARASHTRA
9503939461
himanshupophale@yahoo.co.in
Dr Dnyandeep Sarpe
Life Point Mutispecialty Hospital Pvt. Ltd.
145/1, Mumbai-Bangalore highway Near Hotel Sayaji Wakad Pune Maharashtra - 411057 India Pune MAHARASHTRA
7888143059
sarpednyandeep@gmail.com
Dr Bhanu Pratap Singh
Midland and Research Centre Midland Healthcare And Research Center
Department and Division Pulmonary medicine, Ground floor, B-55And C-42 Mandir Marg Mahanagar Extension Lucknow, 226006 Lucknow UTTAR PRADESH
9415011669
bps2159@yahoo.com
Dr Jaydip Deb
NRS Medical College And Hospital
Department and Division Pulmonary division, NRS MedicalCollege 138, A.J.C Bose Road Kolkata West Bengal -700014 Kolkata WEST BENGAL
9830439804
jaydip.deb@gmail.com
Dr Ashutosh Aggarwal
Postgraduate Institute of Medical Education & Research
Department of Pulmonary Medicine, Postgraduate Institute of Medical Education & Research, 4th Floor, F- Block, Nehru Hospital, PGIMER, Sector-12, Chandigarh (India) 160012 Chandigarh CHANDIGARH
01722756824
aggarwal.ashutosh@outlook.com
Dr Rajkumar Nikalje
Punawale Multispecialty Hospital
ambhe Road Near Khandoba Mandir, Punawale, Pune Maharashtra - 411033 India Pune MAHARASHTRA
9028560535
rajkumar.nikalje23@gmail.com
Dr Ajit Singh Shaktawat
S.M.S Hospital
Department and Division of Pulmonary Medicine, Room No-179,First Floor, Department of allergy & Pulmonary Medicine,Dhanvantri OPD Block, Jaipur, Rajasthan-302004 Jaipur RAJASTHAN
9829135692
dr.ajeetsingh@yahoo.com
Dr Shyam Narain Gupta
Sanjivini hospital and Research Center
Sanjivini Hospital and Research Center, Department ofPulmonology, CP-23, Viraj Khand, Near Hahnemann Chauraha,Gomti Nagar, Lucknow 226010 Uttar Pradesh Lucknow UTTAR PRADESH
9415007110
smsdgupta@gmail.com
Dr Gajendra Vikram Singh
Sarojini Naidu Medical College
Department of Respiratory Medicine, SN Medical College, RajaMandi near Agra College, Agra Central, Agra-280002 Agra UTTAR PRADESH
9634660312
drsinghgv@gmail.com
Dr Jagdish Kumar Rawat
Shri Guru Ram Rai Institute of Medical &Health Sciences and Shri Mahant Indiresh Hospital
Department of Pulmonary Medicine,Shri Guru Ram Rai Institute of Medical &Health Sciences and Shri Mahant Indiresh Hospital, Ground floor, Patel Nagar,Dehradun, Uttarakhand - 248001 Dehradun UTTARANCHAL
9639212630
drjagdishrawat@yahoo.com
Dr Bhavesh Vaghani
SIMS Hospital (Surat Institute of Medical Sciences)
Respiratory OPD, Department and Devision: Respiratorymedicine, Katargam Rd, Near Modh Vanik Vadi, Near RailwayStation, Vijaya Nagar-1, Lal Darwaja, Rughnathpura, Surat-395003, Gujarat Surat GUJARAT
9904262829
dr.bjvaghani@gmail.com
Dr Keyur Brahme
SSG Hospital
Department of medicine, Sir Sayajirao general hospital, MedicalCollege Baroda, Jail Road, Indian Avenue, Vadodara 390001 Vadodara GUJARAT
175 mcg (3 mL vial) for oral inhalation. For use with a standard jet nebulizer. Once Daily For 12 weeks.
Comparator Agent
Tiotropium dry powder for inhalation
18 mcg one Rotacap once daily through dry powder inhaler (DPI- Revolizer). Once Daily For 12 weeks.
Inclusion Criteria
Age From
40.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male and female subjects aged 40 years and above with documented diagnosis of COPD based on Global Initiative for Chronic Obstructive LungDisease guideline 2025
2. Subject has a current or past cigarette smoking history or exposure to noxious stimuli
3. Subjects has a post-ipratropium FEV1/FVC ratio of less than 0.7 and post-ipratropium FEV1 of less than 80% to Greater than and equal to 30% ofpredicted normal and an absolute FEV1 of at least 700 ml at screening.
4. Subjects with CAT score greater than 10.
ExclusionCriteria
Details
1. History of hypersensitivity to similar class of drugs or to any of the excipients of the formulations.
2. Subjects who have previously taken revefenacin.
3. Subjects with history of myocardial infarction or unstable angina within the previous 6 months, unstable or life-threatening cardiac arrhythmia requiringintervention within the previous 3 months.
4. Subject with NYHA Class IV heart failure prior to the start of the study or exhibited an abnormal and clinically significant 12-lead ECG (QTcF greaterthan 500msec) at screening.
5. Subjects with unstable cardiovascular disease including history of one or more of pre-specified cardiac disorders such as ischemic heart disease,cerebrovascular disease, peripheral arterial disease, heart failure and/or hypertension.
6. Any medical condition precluding use of inhaled anticholinergics, including paradoxical bronchospasm, narrow-angle glaucoma, or symptomatic prostatichypertrophy or bladder outlet obstruction, urinary retention.
7. Subjects with concomitant clinically significant respiratory disease, other than COPD as determined by the Investigator such as asthma, bronchiectasis,pulmonary fibrosis, sarcoidosis, pneumoconiosis, active tuberculosis, or a recent history of respiratory tract infection within 6 weeks.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Difference of mean change in trough Forced Expiratory Volume in 1 second (FEV1) between the two treatment groups.
Difference of mean change in trough Forced Expiratory Volume in 1 second (FEV1) between the two treatment groups.
Secondary Outcome
Outcome
TimePoints
Difference of mean change in trough FEV1 between the two treatment groups.
At week 4 and week 8 from baseline
Difference of mean change in trough FVC between the two treatment groups.
At week 4, week 8 and week 12 from baseline
Difference of mean change in COPD Assessment Test (CAT) score between the two treatment groups
At week 4, week 8 and week 12 from baseline
Difference of mean change in St. George’s Respiratory Questionnaire (SGRQ) score between the two treatment groups
At week 4, week 8 and week 12 from baseline
Safety Endpoint:
The incidence of all adverse events including treatment emergent adverse events (TEAEs) and serious adverse events.
Throughout the study period
Target Sample Size
Total Sample Size="362" Sample Size from India="362" 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 3
Date of First Enrollment (India)
05/01/2026
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)
Not Yet Recruiting
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
This will be a multicenter, randomized study including 362 subjects with COPD. Subjects will receive study drug for 12 weeks. Study drug (Revefenacin inhalation solution 175 mcg OD)will be administered using a standard jet nebulizer and compressor via a mouthpiece. Comparator drug (Tiotropium 18mcg OD) will be administered via dry powder inhaler. Subjects will berandomly assigned in a 1:1 ratio, as per randomization code. Subjects will have approximately 6 visits (encompassing a screening period of up to 15 days and a treatment period of 12weeks). Adverse events, concomitant medication use, and rescue medication use since the previous visit will be reviewed at each visit.