Phase 3
Completed N=804
Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
Source: ClinicalTrials.gov NCT00358436 ↗Enrolled (actual)
804
Serious AEs
10.6%
Results posted
Nov 2012
Primary outcomePrimary: Trough FEV1 (L) at 28 Weeks on Treatment — 1.220; 1.162 Liters
Summary
To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough FEV1 (L) at 28 Weeks on Treatment |
1.220; 1.162 | — |
| PRIMARY Trough FEV1 (L) at 12 Weeks on Treatment |
1.233; 1.171 | — |
| SECONDARY Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment |
NA; NA | — |
| SECONDARY Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment |
39.0; 32.8; 61.0; 67.2 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD
Exclusion Criteria
- History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
Data sourced from ClinicalTrials.gov (NCT00358436). 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.