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).

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). - Almirall ACLIFORM-COPD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38263

Enrollment

Registered

2011-08-11

Start date

2012-01-10

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD progressive respiratory disease

Interventions

Inhalation of powder.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Adult male and female patients aged >=40. • Patients with stable moderate to severe COPD (GOLD guidelines): Screening Postbronchodilator test FEV1/FVC =30 and =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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
• Secondary efficacy variables (at Week 24 on treatment): - Improvement of TDI focal score of each aclidinium/formoterol FDC dose compared to placebo. - Change from baseline in SGRQ total score of each aclidinium/formoterol FDC dose compared to placebo.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)