Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

AstraZeneca30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Aclidinium bromide 400 μg bidDRUG

Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days.

Tiotropium 18 μg once-dailyDRUG

Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days.

PlaceboDRUG

Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days.

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 (2)

Almirall Investigational Site #1

Berlin, Germany

Almirall Investigational Site #2

Großhansdorf, Germany

Outcomes

Primary Outcomes

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.

Time frame: Day 15

Secondary Outcomes

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment

Time frame: Day 15

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

Time frame: Day 15

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

Time frame: Day 1

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

Time frame: Day 1

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

Time frame: Day 1

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment

Time frame: Day 15

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment

Time frame: Day 15

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment

Data from ClinicalTrials.gov

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