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

This study is currently recruiting participants.

Verified by Laboratorios Almirall, S.A., March 2009

First Received: March 23, 2009 Last Updated: March 26, 2009 History of Changes

Sponsors and Collaborators:	Laboratorios Almirall, S.A. Forest Laboratories
Information provided by:	Laboratorios Almirall, S.A.
ClinicalTrials.gov Identifier:	NCT00868231

Purpose

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.

Condition	Intervention	Phase
COPD	Drug: Aclidinium bromide Drug: Tiotropium Drug: Placebo	Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide Tiotropium Aclidinium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Further study details as provided by Laboratorios Almirall, S.A.:

Primary Outcome Measures:

Change from baseline in FEV1 at Day 15 on treatment. [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes from baseline in FVC, FEV1 and AUC. [ Time Frame: 15 days ] [ Designated as safety issue: No ]
AEs, laboratory, ECG and vital signs [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental Aclidinium bromide	Drug: Aclidinium bromide Aclidinium bromide
Comparator: Active Comparator Tiotropium 18 µg	Drug: Tiotropium Tiotropium 18 µg
Placebo: Placebo Comparator Placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868231

Contacts

Contact: Estrella Garcia, Ph.D.

estrella.garcia@almirall.com

Locations

Germany
Parexel International GmbH	Recruiting
Berlin, Germany
Principal Investigator: Rainard Fuhr, Dr

Sponsors and Collaborators

Laboratorios Almirall, S.A.

Forest Laboratories

Investigators

Study Director:

Estrella Garcia, Ph.D.

Almirall Investigational Site

More Information

No publications provided

Responsible Party:	Global Development ( Laboratorios Almirall, S.A. )
Study ID Numbers:	M/34273/23
Study First Received:	March 23, 2009
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00868231 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Laboratorios Almirall, S.A.:

COPD
Antimuscarinic

Study placed in the following topic categories:

Neurotransmitter Agents
Cholinergic Antagonists
Anti-Asthmatic Agents
Cholinergic Agents
Muscarinic Antagonists
Lung Diseases, Obstructive
Respiratory Tract Diseases

Bromides
Lung Diseases
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Anticonvulsants
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases

Bromides
Autonomic Agents
Lung Diseases
Therapeutic Uses
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Central Nervous System Agents
Anticonvulsants
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009