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Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination

NCT01462942 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2443

Last updated 2017-02-15

Study results available
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Summary

The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Aclidinium Bromide/Formoterol Fumarate

Inhaled Aclidinium/formoterol Fixed Dose Combination (FDC) low dose (400/6 μg), twice per day

DRUG

Aclidinium Bromide/Formoterol Fumarate

Inhaled Aclidinium/formoterol FDC high dose (400/12 μg), twice per day

DRUG

Aclidinium Bromide

Inhaled Aclidinium 400 μg, twice per day

DRUG

Placebo

Inhaled dose-matched placebo, twice per day

DRUG

Formoterol Fumarate

Inhaled Formoterol 12 μg, twice per day

Sponsors & Collaborators

Principal Investigators

  • Esther Garcia, Ph.D. · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01462942 on ClinicalTrials.gov