Aclidinium/Formoterol Fixed Combination Dose Finding Study

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626522
• Other study ID #: CT001148
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2008
• Last updated: May 28, 2015
• Start date: January 2008

Study information

• Verified date: May 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Aclidinium bromide and formoterol
once daily
• Aclidinium bromide and formoterol placebo
once daily

Locations

Country	Name	City	State
Australia	Pr. Philip Thompson	Nedlands

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Forest Laboratories

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function Tests		several	No
Secondary	Pharmacokinetics and Safety		several	Yes

External Links

•   Co-Sponsor website
•   Sponsor website