NCT01070888

Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma

A Randomized, Double-blind, Double Dummy Crossover Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma in Patients With Persistent Asthma

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma. The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.

Detailed description

The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma. The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication. 40 subjects will be randomized to receive both active medications in separate testing periods to determine the effect on their lung function after exercise testing.

Conditions

• Exercise Induced Asthma

Interventions

Type	Name	Description
DRUG	Budesonide/Formoterol	Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
DRUG	Budesonide	Budesonide 180mcg, 2 puffs twice daily for 2 weeks

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2010-02-18
• Last updated: 2021-07-07
• Results posted: 2014-12-30

Locations

2 sites across 1 country: United States