Clinical Trial To Assess The Efficacy And Safety Of Oral Inhalation Of Fixed Dose Combination Of Glycopyrronium and Formoterol Fumarate Powder for Inhalation As Compared To Marketed Glycopyrronium Powder for Inhalation in COPD patients
- Conditions
- Health Condition 1: null- Chronic Obstructive Pulmonary Disease
- Registration Number
- CTRI/2017/09/009804
- Lead Sponsor
- Restech Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 330
Patients diagnosed with moderate to severe COPD as per the GOLD Guidelines classification at the time of screening:
Post-bronchodilator FEV1/FVC ratio < 0.7;
Post-bronchodilator FEV1 >= 30% to < 80% predicted
-Patients who are current/ex-smokers or patients who have been exposed to other noxious stimuli which led to development of COPD
- Clinically stable COPD within 4 weeks prior to the screening visit and during the screening period
- Written informed consent from the patient
-Patient literate enough to fill the diary card and willing to comply with the protocol requirements
-Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
- Patients with known α1 antitrypsin deficiency
- COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
- Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
- Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period
- Patients who require long-term oxygen therapy (>=12 hours/day) within 4 weeks prior to the screening or during the screening period
- Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
- Patients with known hypersensitivity to formoterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents
- Patients with clinically significant uncontrolled diseases of either of the systems: cardiovascular, renal, neurological, psychiatric, endocrine, immunological, hematological disorders or malignancy
-Clinically significant prolongation of QTc interval ( > 450 msec) at the time of screening.
- Patients with hepatic dysfunction (serum transaminases >= 3 x Upper Normal Limit) or renal dysfunction (serum creatinine >= 2.5 mg/dl)
- Patients with continuing history of alcohol and/or drug abuse
- Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
- Participation in another clinical trial in the past 3 months
- Any other reason for which the investigator feels that patient should not participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in morning pre-dose trough FEV1 at the end of treatment in the two groupsTimepoint: Baseline in morning pre-dose trough FEV1 of Day 1,Week 6 and Week 12 (at the end of treatment)
- Secondary Outcome Measures
Name Time Method Change from baseline in trough FVC at the end of treatment in the two groups <br/ ><br>â?¢ Changes in FEV1 & FVC after drug administration at baseline visit and changes in FEV1 & FVC after drug administration at end of treatment between two groups <br/ ><br>â?¢ Rescue bronchodilator use in the two groups <br/ ><br>â?¢ Intensity score for COPD symptoms in the two groups <br/ ><br>â?¢ COPD exacerbations in the two groups. <br/ ><br>Safety Endpoint: <br/ ><br> <br/ ><br>-Treatment emergent adverse events (TEAEs) <br/ ><br>Timepoint: Not Applicable