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

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Aclidinium bromide 400 μg bid; Drug: Tiotropium 18 μg once-daily; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, D-14050
    • Almirall Investigational Site #1
  • Grosshansdorf, Germany, D-22927
    • Almirall Investigational Site #2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days.
Experimental: Aclidinium 400 μg bid; Aclidinium bromide 400 μg twice-daily by inhalation	Drug: Aclidinium bromide 400 μg bid; Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days.
Active Comparator: Tiotropium 18 μg once-daily; Tiotropium 18 μg once-daily by inhalation	Drug: Tiotropium 18 μg once-daily; Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment	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	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	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	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	Day 1
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment	Day 15
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment	Day 15
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment	Day 15
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 1 on Treatment	Day 1
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment	Day 1
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment	Day 1

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Fuhr R, Magnussen H, Sarem K, Llovera AR, Kirsten AM, Falques M, Caracta CF, Garcia Gil E. Efficacy of aclidinium bromide 400 mug twice daily compared with placebo and tiotropium in patients with moderate to severe COPD. Chest. 2012 Mar;141(3):745-752. doi: 10.1378/chest.11-0406. Epub 2011 Sep 8.

Helpful Links

• Almirall Corporate Website

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: March 23, 2009
• First Submitted That Met QC Criteria: March 23, 2009
• First Posted (Estimate): March 24, 2009

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: COPD; Antimuscarinic
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide; Bromides
• Other Study ID Numbers: M/34273/23