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Study of Safety of Foradil in Patients With Persistent Asthma

NCT01845025 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 827

Last updated 2017-03-21

Study results available
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Summary

The purpose of this study was to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and older) taking inhaled formoterol fumarate/fluticasone propionate combination was the same as those taking inhaled fluticasone propionate alone.

Conditions

  • Persistent Asthma

Interventions

DRUG

Formoterol 12 mcg

Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler

DRUG

Fluticasone propionate 100 mcg

Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler

DRUG

Fluticasone propionate 250 mcg

Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler

DRUG

Fluticasone propionate 500 mcg

Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler

DRUG

Placebo

Placebo to match formoterol one inhalation twice daily via dry powder inhaler

Sponsors & Collaborators

Principal Investigators

  • Chrsitopher Compton · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

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 NCT01845025 on ClinicalTrials.gov