Aclidinium/Formoterol Fixed Combination Dose Finding Study

This study has been completed.
Forest Laboratories
Information provided by (Responsible Party):
Almirall, S.A. Identifier:
First received: February 21, 2008
Last updated: May 28, 2015
Last verified: May 2015
The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for investigation in Phase III clinical trials

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Aclidinium bromide and formoterol
Drug: Aclidinium bromide and formoterol placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, 4-week, Placebo-controlled, Double-blind, 6 Arm Parallel Group, Dose-finding Clinical Trial, to Assess the Efficacy, Safety and Pharmacokinetics of Three Different Doses of Formoterol Combined With the Inhaled Anticholinergic Aclidinium Bromide, Aclidinium Bromide Monotherapy and Formoterol Monotherapy All Administrated Once Daily by Inhalation Via Almirall Inhaler in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease.

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Pulmonary Function Tests [ Time Frame: several ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics and Safety [ Time Frame: several ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 513
Study Start Date: January 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Aclidinium bromide and formoterol
once daily
Experimental: 2 Drug: Aclidinium bromide and formoterol
once daily
Experimental: 3 Drug: Aclidinium bromide and formoterol
once daily
Placebo Comparator: 4 Drug: Aclidinium bromide and formoterol placebo
once daily
Placebo Comparator: 5 Drug: Aclidinium bromide and formoterol placebo
once daily
Placebo Comparator: 6 Drug: Aclidinium bromide and formoterol placebo
once daily

Detailed Description:
Dose-finding clinical trial, to assess the efficacy, safety and pharmacokinetics of three different doses of formoterol combined with the inhaled anticholinergic aclidinium bromide, aclidinium bromide monotherapy and formoterol monotherapy

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females between 40 and 80 years of age inclusive,
  • current or ex-smokers of ≥10 pack-year and with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

  • History or current diagnosis of asthma
  • Allergic rhinitis or atopy
  • Respiratory tract infection or acute COPD exacerbation in the last 6 weeks
  • Hospitalised for an acute COPD exacerbation in the last 3 months
  • Contraindication to the use of anticholinergic drugs
  Contacts and Locations
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Please refer to this study by its identifier: NCT00626522

Pr. Philip Thompson
Nedlands, Australia, WA 6009
Sponsors and Collaborators
Almirall, S.A.
Forest Laboratories
Study Director: Medical Division
  More Information

Additional Information:
Responsible Party: Almirall, S.A. Identifier: NCT00626522     History of Changes
Other Study ID Numbers: CT001148 
Study First Received: February 21, 2008
Last Updated: May 28, 2015
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Almirall, S.A.:
Smokers or ex-Smokers

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants processed this record on July 27, 2016