Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination
The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.
Enrollment: 2443
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms:
- Experimental: Aclidinium/Formoterol 400/6 μg
- Experimental: Aclidinium/Formoterol 400/12 μg
- Experimental: Aclidinium monotherapy 400 μg
- Active Comparator: Formoterol monotherapy 12 μg
- Placebo Comparator: Placebo
Related journal:
- Reduction in clinically important deterioration in chronic obstructive pulmonary disease with aclidinium/formoterol.
| Category | Value |
|---|---|
| Date last updated at source | 2017-02-15 |
| Study type(s) | Interventional |
| Expected enrolment | 2443 |
| Study start date | 2011-10-01 |
| Estimated primary completion date | 2013-01-01 |