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Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

NCT01572792 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 921

Last updated 2017-04-21

Study results available
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Summary

The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.

Conditions

Interventions

DRUG

Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)

Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day

DRUG

Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)

Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day

DRUG

Aclidinium bromide

Inhaled Aclidinium bromide 400 μg, twice per day

DRUG

Formoterol Fumarate

Inhaled Formoterol Fumarate 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
2012-04-30
Primary Completion
2013-06-30
Completion
2013-06-30

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 NCT01572792 on ClinicalTrials.gov