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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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 Pe

Brief 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 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.

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.


Sponsor: Boston Children’s Hospital

Current Primary Outcome: Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide [ Time Frame: 8 weeks ]

Mean difference between maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period, budesonide/formoterol - budesonide, calculated as follows:

(max fall in FEV1(baseline) - maximal fall in FEV1(bud/form) - (max fall in FEV1(baseline) - maximal fall in FEV1(bud))



Original Primary Outcome: Maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period of budesonide alone [ Time Frame: 8 weeks ]

Current Secondary Outcome:

Original Secondary Outcome:

  • The change from baseline in morning PEFR during the 2 weeks of treatment, [ Time Frame: 8 ]
  • change in the percentage of albuterol rescue-free days [ Time Frame: 8 weeks ]
  • time to return to within 5% of pre-exercise value [ Time Frame: 8 weeks ]
  • Difference between eNO values between treatment groups and within groups from run-in to completion of the study. [ Time Frame: 8 weeks ]


Information By: Boston Children’s Hospital

Dates:
Date Received: February 17, 2010
Date Started: February 2010
Date Completion:
Last Updated: December 17, 2014
Last Verified: December 2014