Phase 2
Completed N=109
Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®
Source: ClinicalTrials.gov NCT01048333 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose — 1.072; 1.041; 1.007 percentage change
Summary
* Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.
* Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose |
1.072; 1.041; 1.007 | — |
| SECONDARY Average FEV1 During the First 15 Minutes Post Dose |
1.064; 1.041; 1.012 | — |
| SECONDARY Average FEV1 During 120 Minutes Post Dose |
1.096; 1.082; 1.014 | — |
| SECONDARY Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1 |
23.1; 9.2; 6.4; 38.0; 17.6; 7.3 | 0.002 sig |
| SECONDARY Adverse Events |
6; 6; 2 | — |
Eligibility Criteria
Inclusion Criteria
- A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms
- A current or previous smoking history equivalent to 10 or more packs per year (1 pack year = 20 cigarettes smoked per day for one year).
- Documented use of a short-acting inhaled bronchodilator (β2-agonist or anticholinergics) as reliever medication.
Exclusion Criteria
- A history and/or current diagnosis of asthma.
- Patients who have experienced COPD exacerbation requiring hospitalisation and/or a course of antibiotics and/or a course of systemic steroid within 30 days (from end of exacerbation treatment) prior to Visit 1 and/or during the run-in period.
- A history and/or current diagnosis of atopic diseases such as allergic rhinitis or eczema before the age of 40.
Data sourced from ClinicalTrials.gov (NCT01048333). 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.