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

NCT01437540 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 590

Last updated 2017-05-11

Study results available
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Summary

The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).

Conditions

Interventions

DRUG

Aclidinium Bromide/Formoterol Fumarate

Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day

DRUG

Formoterol Fumarate

Inhaled formoterol fumarate 12 μg, 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
2011-09-19
Primary Completion
2013-03-31
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01437540 on ClinicalTrials.gov