A Randomized, Multicenter, Open-label, Active-controlled, Single-dose, 5-period, Incomplete Block, Cross-over Study to Evaluate the Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort pMDI or Oxis Turbuhaler to Adults With Stable Asthma

AstraZeneca0 sites175 target enrollmentOctober 2002

ConditionsStable Asthma

Interventionsformoterol budesonide/formoterol

Drugsbudesonide/formoterol formoterol

Overview

Phase: Phase 2
Intervention: formoterol
Conditions: Stable Asthma
Sponsor: AstraZeneca
Enrollment: 175
Primary Endpoint: Average FEV1 during 12 hours
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

May 2003

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•At least 18 years of age
•Diagnosis of asthma and baseline lung function tests as determined by the protocol
•Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion Criteria

•Severe asthma
•Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

Arms & Interventions

2

Intervention: formoterol

1

Intervention: budesonide/formoterol

Outcomes

Primary Outcomes

Average FEV1 during 12 hours

Time Frame: Once a week for 5 weeks during treatment period

Secondary Outcomes

Urine levels of formoterol in 2 different formulations(Once a week (12 hour urine collection) for 5 weeks during treatment period)
Safety profiles of formoterol in 2 different formulations(Once a week for 5 weeks during treatment period)