CTRI/2024/10/075606RecruitingPhase 3
A randomized, double-blind, double-dummy clinical trial to assess the efficacy and safety of fixed dose combination of Glycopyrronium 25 µg, Formoterol Fumarate 20 µg, Budesonide 500 µg Inhalation Suspension (for nebulization) in comparison with fixed dose combination of Formoterol Fumarate Dihydrate 5 µg, Glycopyrronium 7.2 µg and Budesonide 160 µg pressured inhalation suspension in patients with chronic obstructive pulmonary disease.
Glenmark Pharmaceuticals Ltd18 sites in 1 country314 target enrollmentStarted: November 7, 2024Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 314
- Locations
- 18
- Primary Endpoint
- Change from baseline in trough FEV1
Study Overview
Brief Summary
This is a randomized, double-blind, double-dummy clinical trial to assess the efficacy and safety of fixed dose combination of Glycopyrronium 25 µg, Formoterol Fumarate 20 µg, Budesonide 500 µg Inhalation Suspension (for nebulization) in comparison with fixed dose combination of Formoterol Fumarate Dihydrate 5 µg, Glycopyrronium 7.2 µg and Budesonide 160 µg pressured inhalation suspension in patients with chronic obstructive pulmonary disease.
The total study duration for each subject is approximately 16 weeks; which consists of screening period up to 7 days, run-in period of 2 weeks followed by 12 weeks’ treatment period.
The primary outcome measures consist of change from baseline in in trough FEV1 at week 12.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Double
Eligibility Criteria
- Ages
- 40.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Consent: Provide written informed consent and willing to comply with all aspects of the protocol
- •Risk Factor history a.
- •Tobacco smoke: Current or previous cigarette/beedi smokers with a history of cigarette/beedi smoking of at least 10 pack-years.
- •Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Screening Visit.
- •Others: Chronic exposure to smoke including biomass fuel smoke.
- •COPD: Diagnosis of COPD (as defined by the GOLD, 2024)
- •Ability to use drug-device: Ability to use nebulized medication independently & correctly in view of the investigator.
Exclusion Criteria
- •A current or historic diagnosis of asthma.
- •Treatment with triple therapy, i.e. long-acting muscarinic agonist (LAMA), long-acting beta-agonist (LABA) and inhaled corticosteroids (ICS) in one or multiple inhalers, within 1 month before screening.
- •Known respiratory disorders other than COPD including but not limited to alpha-1 antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, history of allergic rhinitis or atopy, pulmonary hypertension, pneumothorax in last 6 months and interstitial lung disease.
- •Any previous lung resection surgery (e.g., lung volume reduction surgery or lobectomy).
- •Chest X-ray or CT scan, which reveals evidence of clinically significant abnormalities, not believed to be due to the presence of COPD (e.g., evidence of pneumonia, other infection, atelectasis, or pneumothorax).
- •Type I or uncontrolled Type II diabetes.
- •History of narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate-to-severe renal impairment or urinary retention (Subjects with a transurethral resection of prostate, subjects who have undergone full re-section of the prostate and, subjects who are asymptomatic and stable on pharmacological treatment for the condition will be considered for the study).
- •Has a clinically significant laboratory abnormality or a clinically significant condition, in the judgment of the investigator.
- •An abnormal and clinically significant 12-lead electrocardiogram (ECG) as per investigator’s judgement.
- •For the purposes of this study, an abnormal ECG will be defined as a 12-lead tracing which is interpreted with (but not limited to) any of the following: a.
- •Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome) b.
- •Unstable ischemic heart disease c.
- •Clinically significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia) d.
- •left ventricular failure (New York Heart Association Class III and IV) e.
- •A mean QTcF value at screening ≥ 450 msec (for males) / ≥ 470 msec (for females) or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave)
- •History of allergy or hypersensitivity to the study medications or any of the excipients.
- •Additional Medications: Unable to stop the medications required to be washed out prior to screening spirometry as per the Drug Withholding for Screening Spirometry:
- •Pregnant or lactating women.
Outcomes
Primary Outcomes
Change from baseline in trough FEV1
Time Frame: Time Point: at week 12
Secondary Outcomes
- Change from baseline in trough FEV1(Time Point: at week 4 and week 8)
- Change from baseline in 2-hour post-dose FEV1(Time Point: at week 12)
- Rescue medication use averaged(Time Point: Over week 11 and 12)
- Change from baseline in trough forced vital capacity (FVC)(Time at week 12)
- Change from baseline in modified Medical Research Council (mMRC) score(Time Point: at week 12)
Investigators
Study Sites (18)
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