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Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT00706914 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2017-05-15

Study results available
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Summary

This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Once-daily aclidinium/formoterol

Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning

DRUG

Twice-daily formoterol fumarate

Inhaled formoterol fumarate 12 µg twice-daily (BID)

DRUG

Placebo to formoterol fumarate

Inhaled placebo to formoterol fumarate once-daily in the evening

DRUG

Once-daily formoterol fumarate

Inhaled formoterol fumarate 12 μg once-daily in the evening

Sponsors & Collaborators

Principal Investigators

  • Esther Garcia, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-11-11
Completion
2008-11-11

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00706914 on ClinicalTrials.gov