CTRI/2025/06/089258 [Registered on: 20/06/2025] Trial Registered Prospectively
Last Modified On:
22/08/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
Study to assess the efficacy and safety of Revefenacin inhalation solution in the patients with COPD
Scientific Title of Study
A Prospective, Randomized, Open label, Parallel, Active controlled, Multicentre, Phase III clinical trial to assess the efficacy and safety of Revefenacin inhalation solution as compared to Glycopyrronium inhalation solution in the patients with moderate to very severe Chronic Obstructive Pulmonary Disease
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: 24-03 Version: 01 Date: 03/02/2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
02717698500
Fax
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Associate Director - II
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
07966219500
Fax
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Devesh Verma
Designation
Director
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
09712908404
Fax
Email
dverma@cliantha.com
Source of Monetary or Material Support
Zydus Healthcare Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad-382481, Gujarat, India
Primary Sponsor
Name
Zydus Healthcare Limited
Address
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad-382481, Gujarat, India
Clinical Research Room, Department of Respiratory Medicine, Belagavi Institute of Medical Sciences, Dr Ambedkar Road, Sadashiv Nagar, Belagavi-590001, Karnataka Belgaum KARNATAKA
9964451057
honnavar.santosh@gmail.com
Dr Bhavesh Patel
Dhiraj Hospital
OPD Building, SBKS MI & RC, SVDU, At & Po. Piparia, Ta. Waghodia - 391760, Vadodara, Gujarat Vadodara GUJARAT
9898204670
drbhavesh.cr@gmail.com
Dr Sahoo Srinibas
Hi-Tech Medical College & Hospital
Ground Floor, PG Department of Respiratory Medicine, Hi-Tech Medical College & Hospital, Health Park, Pandara, Bhubaneswar-751025, Odisha Khordha ORISSA
Patients will be dispensed marketed pack of Glycopyrronium inhalation solution 25 mcg as a reference drug. It will be administered by oral inhalation twice daily by nebulizer using a mouthpiece. One dose to be administered in morning and another dose in evening to make it total recommended dose of 50 mcg. Treatment should be continued for 12 Weeks.
Intervention
Revefenacin inhalation solution 175 mcg
Patients will be dispensed revefenacin inhalation solution 175 mcg administered by oral inhalation once daily in morning by nebulizer using a mouthpiece. No dosage adjustment is required for geriatric patients, or patients with renal impairment. Treatment should be continued for 12 Weeks
Inclusion Criteria
Age From
40.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Patients of either gender from 40 years of age Females may be of either childbearing or non-childbearing potential. All females of childbearing potential must be using an acceptable, highly effective method of contraception and have a negative pregnancy test at screening
2. A clinical diagnosis of moderate to very severe COPD for at least 6 months prior to screening according to GOLD guidelines o Post-bronchodilator FEV1/FVC ratio less than 0.7; o Post-bronchodilator FEV1 less than 80 percent predicted
3. Current smoker or ex-smoker, with a history of at least 10 pack-years of tobacco smoking. Ex-smokers must have stopped smoking greater than 6 months prior to Visit 1.
4. Capable of self-administering (or with the help of a caregiver) study medication
5. Able to understand and complete the study requirements, provide written informed consent, and agree to abide by the study protocol and its restrictions 6. Patients literate enough to fill the diary card
ExclusionCriteria
Details
1. Previously dosed with revefenacin and/or glycopyrronium inhalation solution
2. Current diagnosis of asthma.
3. Alpha-1 anti-trypsin deficiency.
4. Other chronic or active respiratory disorder
5. Symptoms of, or treatment for an AE COPD requiring antibiotics and/or oral/systemic corticosteroids or in-patient hospitalization.
6. History or presence of pulmonary hypertension, respiratory failure, corpulmonale or right ventricular failure, surgical treatments to the lungs.
7. Use of supplemental oxygen therapy for more than 15 hours per day.
8. Subjects participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the trial (maintenance program is permitted).
9. Clinically significant, abnormal chest X-ray at screening indicating an active/significant disease process other than COPD
10. Subject suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention.
11. Use of medications with the potential to interact with revefenacin, glycopyrronium, salbutamol or ipratropium bromide or medications with the potential to affect or confound COPD disease status.
12. History of reactions/hypersensitivity to any of the following inhaled drugs or drugs of a similar class: short- or long- acting Beta 2 agonists, anticholinergic agents, corticosteroids, sympathomimetic amines.
13. Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy.
14. Patients with hepatic dysfunction (serum transaminases greater than or equals to 3 x Upper Normal Limit) or renal dysfunction (serum creatinine greater than or equals to 2.5 mg/dl) at screening
15. Patients with continuing history of alcohol and/or drug abuse.
16. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception.
17. Participation in another clinical trial in the past 3 months.
18. Any other reason for which the investigator feels that the patient should not participate
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change from baseline (CFB) in trough FEV1
12 week
Secondary Outcome
Outcome
TimePoints
1. CFB to Peak FEV1 (during the 2 hours post-dose)
On first-day dosing (visit 2)
2. CFB to Peak FVC (during the 2 hours post-dose)
On first-day dosing (visit 2)
3. Change from baseline in trough FEV1
At week 4
4. Change from baseline in trough FVC
At week 4 and at the end of 12 week
5.Change from baseline in St. Georges Respiratory Questionnaire responders
At the end of 12 week
Target Sample Size
Total Sample Size="242" Sample Size from India="242" 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)
12/07/2025
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="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 Prospective, Randomized, Open label, Parallel,
Active-controlled, Multicentre study planned to evaluate the efficacy and
safety of the test drug, Revefenacin inhalation solution 175 mcg compared with
reference drug, Glycopyrronium inhalation solution 25 mcg in the patients with
moderate to very severe COPD.