Phase 3 Completed N=112 Randomized Double-blind Treatment

Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT01471171 ↗

Enrolled (actual)

112

Serious AEs

0.9%

Results posted

Jul 2013

Primary outcomePrimary: Change From Baseline in Endurance Time (Seconds) — 68.3; 9.8 Seconds

Summary

The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Endurance Time (Seconds)	68.3; 9.8	—
SECONDARY Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)	0.098; 0.020	—
SECONDARY Change From Baseline in Intensity of Dyspnoea	-0.48; 0.15	—

Eligibility Criteria

Inclusion Criteria

Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
Post-salbutamol Forced Expiratory Volume in one second(FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) < 70%.
Current or ex-smokers of ≥ 10 pack-years
Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value

Exclusion Criteria

History or current diagnosis of asthma
Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Patients with an oxygen saturation < 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.
Contra-indications of cardiopulmonary exercise testing.
Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.

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Data sourced from ClinicalTrials.gov (NCT01471171). 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.