Phase 3
Completed N=1,692
Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01572792 ↗Enrolled (actual)
1,692
Serious AEs
7.3%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Patients to Experience Any Treatment-emergent Adverse Event — 56.8; 65.9; 61.3; 67.5 Percentage of participants
Summary
The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients to Experience Any Treatment-emergent Adverse Event |
56.8; 65.9; 61.3; 67.5; 64.6 | — |
| SECONDARY Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis |
32.9; 41.2; 35.3; 32.5; 38.5 | — |
| SECONDARY Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value |
53.4; 53.8; 55.9; 60.4; 48.4; 3.4 | — |
| SECONDARY Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight) |
27.4; 24.2; 18.6; 22.2; 24.5 | — |
Eligibility Criteria
Inclusion Criteria
- Completion of the treatment phase of the lead-in study, LAC-MD-31
- Written informed consent obtained from the patient before the initiation of any study specific procedures
- No medical contraindication as judged by the PI
- Compliance with LAC-MD-31 study procedures and IP dosing.
Exclusion Criteria
- No specific exclusion criteria
Data sourced from ClinicalTrials.gov (NCT01572792). 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.