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Aclidinium/Formoterol Fixed Combination Dose Finding Study

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT00626522
First received: February 21, 2008
Last updated: July 9, 2010
Last verified: July 2010
History of Changes
  Purpose

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
 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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626522

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

Additional Information:
Sponsor website  This link exits the ClinicalTrials.gov site
Co-Sponsor website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Laboratorios Almirall, S.A, R&D Medical Division
ClinicalTrials.gov Identifier: NCT00626522     History of Changes
Other Study ID Numbers: CT001148
Study First Received: February 21, 2008
Last Updated: July 9, 2010
Health Authority: Australia: National Health and Medical Research Council

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

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Formoterol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-2 Receptor Agonists
 Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 16, 2013