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

AstraZeneca414 enrolled

Overview

The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

414

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Aclidinium bromideDRUG

Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)

TiotropiumDRUG

Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)

PlaceboDRUG

Dosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (41)

Outcomes

Primary Outcomes

Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment

Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.

Time frame: Week 6

Secondary Outcomes

Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment

Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.

Time frame: Week 6

Data from ClinicalTrials.gov

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Almirall Investigational Site #9

Humpolec, Czechia

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Jaroměř, Czechia

Almirall Investigational Site #3

Mělník, Czechia

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Berlin, Germany

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Berlin, Germany

Almirall Investigational Site #10

Berlin, Germany

Almirall Investigational Site #8

Berlin, Germany

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Berlin, Germany

Almirall Investigational Site #21

Berlin, Germany

Almirall Investigational Site #2

Berlin, Germany

...and 31 more locations