Phase 2
Completed N=118
Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Moderate to Severe COPD
Source: ClinicalTrials.gov NCT00690482 ↗
Enrolled (actual)
118
Serious AEs
0.9%
Results posted
Dec 2013
Primary outcomePrimary: FEV1 — 0.007; 0.011 L
Summary
The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1 |
0.007; 0.011 | — |
| PRIMARY Clinical COPD Questionnaire |
-0.299; -0.340 | — |
| SECONDARY Forced Vital Capacity |
-0.047; -0.102 | — |
| SECONDARY Slow Vital Capacity |
-0.001; -0.009 | — |
| SECONDARY Inspiratory Capacity |
-0.007; -0.110 | — |
| SECONDARY FEF25%-75% |
-0.042; 0.060 | — |
| SECONDARY COPD Symptom Sleep Score |
-0.147; -0.047 | — |
| SECONDARY COPD Symptom Breathing Score |
-0.280; -0.137 | — |
| SECONDARY COPD Symptom Cough Score |
-0.202; -0.124 | — |
| SECONDARY COPD Symptom Sputum Score |
-0.300; -0.290 | — |
| SECONDARY PEF (Peak Expiratory Flow) Morning |
2.86; 4.54 | — |
| SECONDARY PEF (Peak Expiratory Flow) Evening |
-1.61; 5.73 | — |
| SECONDARY Total Use of Reliever |
-0.330; -0.139 | — |
| SECONDARY Adverse Event |
20; 18 | — |
Eligibility Criteria
Inclusion Criteria
- FEV1 between 30 and 80% of predicted normal value post-bronchodilator (GOLD stages 2 and 3)
- Clinical diagnosis of COPD
Exclusion Criteria
- Other clinically relevant disease or disorders
- Exacerbation of COPD within 30 days
Data sourced from ClinicalTrials.gov (NCT00690482). 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.