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Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate

NCT01078623 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2017-02-23

Study results available
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Summary

The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD.

Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

Conditions

Interventions

DRUG

Aclidinium 200 μg / formoterol 12 μg

Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily

DRUG

Placebo

Placebo control twice daily

DRUG

Formoterol 12 μg

Formoterol fumarate 12 μg twice daily

DRUG

Aclidinium 200 μg

Aclidinium bromide 200 μg twice daily

DRUG

Aclidinium 200 μg / Formoterol 6 μg

Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily

Sponsors & Collaborators

Principal Investigators

  • Esther Garcia, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Czechia
  • Romania

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 NCT01078623 on ClinicalTrials.gov