Study to assess the efficacy and safety of Revefenacin inhalation solution in the patients with COPD

Phase 3

Not yet recruiting

• Conditions: Chronic obstructive pulmonary disease, unspecified,

• Registration Number: CTRI/2025/06/089258
• Lead Sponsor: Zydus Healthcare Limited

Brief Summary

A Prospective, Randomized, Open label, Parallel,Active-controlled, Multicentre study planned to evaluate the efficacy andsafety of the test drug, Revefenacin inhalation solution 175 mcg compared withreference drug, Glycopyrronium inhalation solution 25 mcg in the patients withmoderate to very severe COPD.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-07
• Last Update Posted: 2025-06-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline (CFB) in trough FEV1	12 week

Secondary Outcome Measures

Name	Time	Method
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
5.Change from baseline in St. Georges Respiratory Questionnaire responders	At the end of 12 week
4.Change from baseline in trough FVC	At week 4 and at the end of 12 week

Trial Locations

Locations (6)

Aatman Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Belagavi Institute Of Medical Science; 🇮🇳 Belgaum, KARNATAKA, India

Hi-Tech Medical College & Hospital; 🇮🇳 Khordha, ORISSA, India

Maharaja Agrasen Superspeciality Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

MLN Medical College; 🇮🇳 Allahabad, UTTAR PRADESH, India

Murarilal Chest Hospital; 🇮🇳 Nagar, UTTAR PRADESH, India

Aatman Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Chintan Patel

Principal investigator

9825182251

Drchintan.cr@gmail.com