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 (COPD).

Phase 3

Completed

• Conditions: COPD; progressive respiratory disease; 10006436

• Registration Number: NL-OMON38263
• Lead Sponsor: Almirall

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

• Adult male and female patients aged >=40.
• Patients with stable moderate to severe COPD (GOLD guidelines): Screening Postbronchodilator
test FEV1/FVC < 70% and FEV1 >=30 and < 80% of predicted normal value.
• Current or ex*smokers of >=10 pack-years.
• Patients who were never randomised in a study involving aclidinium/formoterol fixed-dosecombination (Almirall project code 40464).
• Patients previously randomised in aclidinium monotherapy trial (Almirall project code 34273) are
allowed in this study only if time elapsed since the finalisation of the previous trial treatment is at
least 6 months prior to the Screening Visit.

Exclusion Criteria

• Patients with history or current diagnosis of asthma
•Patients with no signs of a COPD exacerbation within 6 weeks prior to the screening visit
• Patients with evidence of clinically significant respiratory and/or cardiovascular conditions or
laboratory abnormalities.
• Patients who are expected to start a pulmonary rehabilitation program during the trial, or
those who finished or started it within 3 months prior to the Screening Visit.
• Patients with contraindication to anticholinergic drugs such as bladder neck obstruction, acute
urinary retention, symptomatic non-stable prostatic hypertrophy or (known) narrow-angle
glaucoma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Co-primary efficacy variables (at Week 24 on treatment):<br /><br>- Change from baseline in morning pre-dose (through) FEV1 of each<br /><br>aclidinium/formoterol<br /><br>FDC dose compared to formoterol monotherapy 12 µg.<br /><br>- Change from baseline in 1-hour post-morning dose FEV1 of each<br /><br>aclidinium/formoterol FDC<br /><br>dose compared to aclidinium monotherapy 400 µg.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Secondary efficacy variables (at Week 24 on treatment):<br /><br>- Improvement of TDI focal score of each aclidinium/formoterol FDC dose<br /><br>compared to<br /><br>placebo.<br /><br>- Change from baseline in SGRQ total score of each aclidinium/formoterol FDC<br /><br>dose<br /><br>compared to placebo.</p><br>