Health Condition 1: null- Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Intervention1: Glycopyrronium and Formoterol Fumarate Powder for Inhalation
(25 plus 6 mcg)
: Glycopyrronium and Formoterol Fumarate Powder for Inhalation
(25 plus 6 mcg)
M/s.Restech Pharmaceutica
Sponsors
Restech Pharmaceuticals
Eligibility
Inclusion 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 Post-bronchodilator FEV1 >= 30% to -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
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. - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change from baseline in trough FVC at the end of treatment in the two groups 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 â?¢ Rescue bronchodilator use in the two groups â?¢ Intensity score for COPD symptoms in the two groups â?¢ COPD exacerbations in the two groups. Safety Endpoint: -Treatment emergent adverse events (TEAEs) Timepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactVidhu Shekhar Mishra
Cliantha Research Ltd
Outcome results
None listed