Phase 2
Completed N=30
Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Source: ClinicalTrials.gov NCT00868231 ↗Enrolled (actual)
30
Serious AEs
1.2%
Results posted
Sep 2012
Primary outcomePrimary: Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment. — 0.236; 0.260; 0.015 Liters
Summary
The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment. |
0.236; 0.260; 0.015 | — |
| SECONDARY Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment |
0.174; 0.096; -0.032 | — |
| SECONDARY Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment |
0.226; 0.178; -0.006 | — |
| SECONDARY Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC0-12) in Liters at Day 1 on Treatment |
0.230; 0.178; 0.016 | — |
| SECONDARY Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment |
0.202; 0.101; -0.060 | — |
| SECONDARY Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment |
0.211; 0.138; -0.024 | — |
| SECONDARY Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment |
0.297; 0.345; 0.009 | — |
| SECONDARY Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment |
0.224; 0.087; -0.095 | — |
| SECONDARY Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment |
0.281; 0.219; -0.039 | — |
| SECONDARY Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 1 on Treatment |
0.331; 0.289; 0.005 | — |
| SECONDARY Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment |
0.293; 0.150; -0.127 | — |
| SECONDARY Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment |
0.310; 0.215; -0.051 | — |
Eligibility Criteria
Inclusion Criteria
- Adult male and female patients aged 40 with stable moderate to severe COPD (GOLD guidelines).
- Post-salbutamol (FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
- Current or ex smokers of 10 pack-years.
Exclusion Criteria
- Patients with no history or current diagnosis of asthma.
- No evidence of an exacerbation within 6 weeks prior to the screening visit.
- No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
- No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Data sourced from ClinicalTrials.gov (NCT00868231). 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.