A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-National, Phase III, Efficacy and Safety Study of Inhaled Formoterol 4.5 microgram and 9 microgram Twice Daily in Japanese and European Patients With Chronic Obstructive Pulmonary Disease (COPD)
Phase 3
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- JPRN-jRCT2080220626
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Accepts Healthy Volunteers: No
-Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms
-Current or previous smoker with a smoking history of 10 or more pack years
-Lung function parameters: FEV1/FVC < 70%, post-bronchodilator and post-bronchodilator FEV1 < 80% of predicted normal value
Exclusion Criteria
-History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis
-Use of inhaled glucocorticosteroids within 4 weeks prior to eligibility evaluation
-Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To show that formoterol 4.5 microgram and 9 microgram twice daily are superior to placebo in Japanese and European COPD patients treated for 12 weeks by evaluation of FEV1 60 minutes post-dose [ Time Frame: evaluated 60 minutes post-dose at each visit for 12 weeks ] [ Designated as safety issue: No ]
- Secondary Outcome Measures
Name Time Method Evaluate the onset of action of formoterol 4.5 microgram and 9 microgram using placebo as a control, by evaluation of FEV1 as the primary objective [ Time Frame: Evaluated 5 minutes post-dose at Visit 3 ] [ Designated as safety issue: No ]<br><br>Compare the effect of formoterol 4.5 microgram twice daily to that of formoterol 9 microgram twice daily by evaluation of the same primary and secondary variables as for the primary objective [ Time Frame: evaluated at each visit for 12 weeks ] [ Designated as safety issue: No ]<br><br>Evaluate the safety of formoterol 4.5 microgram and 9 microgram twice daily for 12 weeks in terms of: - Adverse events, laboratory variables, 12-lead ECG, blood pressure and pulse rate [ Time Frame: evaluated at each visit for 12 weeks ] [ Designated as safety issue: No ]