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Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma

NCT01641081 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2017-02-28

Study results available
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Summary

The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma.

This study will include a screening visit followed by a 4 month treatment period.

Conditions

Interventions

DRUG

Formoterol Fumarate in the Pressair DPI, Low Dose

Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days

DRUG

Formoterol Fumarate in the Pressair DPI, High Dose

Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days

DRUG

Foradil Aerolizer, Low Dose

Foradil Aerolizer 12 micrograms, twice a day for 14 days

DRUG

Foradil Aerolizer, High Dose

Foradil Aerolizer 24 micrograms, twice per day for 14 days

DRUG

Placebo

Placebo in the Pressair for 14 days

Sponsors & Collaborators

Principal Investigators

  • Esther Garcia, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

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 NCT01641081 on ClinicalTrials.gov