Trial intelligence / Profile preview

Budesonide/Formoterol As-needed for Exercise Induced Bronchoconstriction in Mild Asthma

NCT00989833Phase 2

Key facts

Status: Completed
Start: Sep 2009
Primary completion: Jul 2010
Countries: 2
Sponsor: AstraZeneca
Modality: Orthosteric Ligands

Drugs: budesonideformoterol
Conditions: Exercise-induced bronchoconstriction (EIB)

Overview

Phase 2, randomised, double-blind trial of budesonide and formoterol in Exercise-induced bronchoconstriction (EIB) (3 arms), sponsored by AstraZeneca. Primary endpoint: Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks. Started Sep 2009; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Regular Budesonide + Terbutaline
Budesonide 400µg daily + Terbutaline 0.4mg as-needed
Terbutaline
Placebo maintenance + Terbutaline 0.4mg as-needed
Budesonide/Formoterol
Placebo maintenance + Budesonide/Formoterol 160/4.5µg as-needed

Who it enrols

Adults and adolescents with a history of exercise induced asthma and maximum 4 asthmatic episodes per week requiring reliever medication. Patients with previous treatment with inhaled oral corticosteroids during the last month are excluded.

Endpoints

Primary

Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks6 weeks

Secondary

Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks3 weeks
Bronchial Responsiveness to Mannitol6 weeks
Concentration of Exhaled Nitric Oxide6 weeks
Use of as Needed Medication6 weeks
Asthma Control Measured by a 5-item Asthma Control Questionnaire6 weeks
Diary Recording of Asthma Symptoms6 weeks
Number of Participants With an Adverse Event During the Study6 weeks

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