A Phase III, Long-term, Randomized, Double-blind, Extension Study of the 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)
Overview
- Phase
- Phase 3
- Intervention
- Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- AstraZeneca
- Enrollment
- 921
- Locations
- 208
- Primary Endpoint
- Percentage of Patients to Experience Any Treatment-emergent Adverse Event
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
1
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose
Intervention: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
2
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose
Intervention: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
3
Aclidinium bromide 400 μg
Intervention: Aclidinium bromide
4
Formoterol Fumarate 12 μg
Intervention: Formoterol Fumarate
5
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of Patients to Experience Any Treatment-emergent Adverse Event
Time Frame: Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)
For each safety parameter, the last assessment made before the first dose of investigational product in the lead-in study (LAC MD-31) was used as the baseline for all analyses of that safety parameter in this extension study
Secondary Outcomes
- Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis(Baseline of lead-in study to end of treatment (up to Week 52))
- Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value(Baseline of lead-in study to end of treatment (up to Week 52))
- Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)(Baseline of lead-in study to end of treatment (up to Week 52))