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

February 21, 2008
July 9, 2010
January 2008
November 2008   (final data collection date for primary outcome measure)
Pulmonary Function Tests [ Time Frame: several ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00626522 on ClinicalTrials.gov Archive Site
Pharmacokinetics and Safety [ Time Frame: several ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Aclidinium/Formoterol Fixed Combination Dose Finding Study
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.

The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for investigation in Phase III clinical trials

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Aclidinium bromide and formoterol
    once daily
  • Drug: Aclidinium bromide and formoterol placebo
    once daily
  • Experimental: 1
    Intervention: Drug: Aclidinium bromide and formoterol
  • Experimental: 2
    Intervention: Drug: Aclidinium bromide and formoterol
  • Experimental: 3
    Intervention: Drug: Aclidinium bromide and formoterol
  • Placebo Comparator: 4
    Intervention: Drug: Aclidinium bromide and formoterol placebo
  • Placebo Comparator: 5
    Intervention: Drug: Aclidinium bromide and formoterol placebo
  • Placebo Comparator: 6
    Intervention: Drug: Aclidinium bromide and formoterol placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
513
Not Provided
November 2008   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00626522
CT001148
No
Laboratorios Almirall, S.A, R&D Medical Division
Almirall, S.A.
Forest Laboratories
Study Director: Medical Division
Almirall, S.A.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP