CTRI/2017/09/009804
Completed
Phase 3
To Evaluate Efficacy And Safety Of Oral Inhalation Of Fixed Dose Combination Of Glycopyrronium and Formoterol Fumarate Powder for Inhalation (25 plus 6 mcg) As Compared To Marketed Glycopyrronium Powder for Inhalation 50 mcg In Patients With Chronic Obstructive Pulmonary Disease
Restech Pharmaceuticals0 sites330 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Restech Pharmaceuticals
- Enrollment
- 330
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\-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.
Outcomes
Primary Outcomes
Not specified
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