Phase 3
Completed N=613
Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU
Source: ClinicalTrials.gov NCT00628862 ↗Enrolled (actual)
613
Serious AEs
2.8%
Results posted
Oct 2012
Primary outcomePrimary: Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose — 112.9; 113.36; 101.28 percent of baseline
Summary
The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose |
112.9; 113.36; 101.28 | — |
| SECONDARY Forced Vital Capacity (FVC) 60 Minutes Post-dose |
109.73; 109.92; 102.11 | — |
| SECONDARY FEV1 Pre-dose |
104.54; 104.65; 99.77 | — |
| SECONDARY FVC Pre-dose |
103.62; 103.36; 100.73 | — |
| SECONDARY FEV1 5 Minutes Post-dose |
110.16; 110.24; 101.25 | — |
| SECONDARY FVC 5 Minutes Post-dose |
108.50; 108.88; 101.59 | — |
| SECONDARY Change in Peak Expiratory Flow (PEF), Morning |
16.27; 18.34; 3.60 | — |
| SECONDARY Change in Peak Expiratory Flow (PEF), Evening |
13.15; 15.76; 2.36 | — |
| SECONDARY Change in Night-time Awakenings Due to Symptoms |
-0.1318; -0.1748; -0.0466 | — |
| SECONDARY Breathlessness |
-0.4068; -0.4531; -0.2626 | — |
| SECONDARY Cough |
-0.3250; -0.4088; -0.2016 | — |
| SECONDARY Use of Reliever Medication |
-0.60; -0.97; -0.23 | — |
| SECONDARY St George's Respiratory Questionnaire (SGRQ) |
-5.46; -6.38; -2.02 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Visit 2
- Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.
Data sourced from ClinicalTrials.gov (NCT00628862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.