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Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01437397 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1692

Last updated 2017-03-23

Study results available
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Summary

The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo.

Conditions

Interventions

DRUG

Aclidinium Bromide/Formoterol Fumarate

Inhaled Aclidinium/formoterol FDC 400/12μg, twice per day

DRUG

Aclidinium Bromide/Formoterol Fumarate

Inhaled Aclidinium/formoterol FDC 400/6μg, twice per day

DRUG

Aclidinium Bromide

Inhaled Aclidinium 400 μg, twice per day

DRUG

Formoterol Fumarate

Inhaled Formoterol 12 μg, twice per day

DRUG

Placebo

Inhaled dose-matched placebo, twice per day

Sponsors & Collaborators

Principal Investigators

  • Esther Garcia, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States
  • Australia
  • Canada
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437397 on ClinicalTrials.gov