Efficacy and safety of four doses of glycopyrronium bromide in patients with stable COPD, in comparison to an active comparator tiotropium.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- JPRN-jRCT2080220418
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 73
-Male or female adults aged >=40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
-Patients with moderate to severe COPD according to the GOLD Guidelines (2006).
-Patients who have smoking history of at least 10 pack years.
-Patients with a post-bronchodilator FEV1 >=30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2.
Exclusion criteria:
-Pregnant women or nursing mothers and females of childbearing potential who do not use a reliable contraceptive method.
-Patients requiring oxygen therapy on a daily basis for chronic hypoxemia
-Patients who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or during the run-in period.
-Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1.
-Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition
-Patients with a history of asthma indicated by (but not limited to): blood eosinophil count > 400/mm3, or onset of symptoms prior to age 40 years.
-Patients contraindicated for tiotropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy primary endpoint:Trough FEV1 at day 7 of each treatment period. Trough FEV1 is defined as the mean of 23 hours 15 mins and 23 hours 45 mins post dose. Efficacy secondary endpoint:FEV1 and FVC: at time points: -45, -15, 5, 15, 30 minutes, 1, 2, 3, 4, 5, 23h 15 min & 23h 45 min post dose on day 1 and day 7 of each treatment period. Safety assessments:Monitoring for adverse events, vital signs, ECGs and laboratory evaluations
- Secondary Outcome Measures
Name Time Method