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
Overview
- Phase
- Phase 4
- Intervention
- Budesonide/Formoterol
- Conditions
- Exercise Induced Asthma
- Sponsor
- Boston Children's Hospital
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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 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.
Investigators
Wanda Phipatanakul
Study PI
Boston Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •Male or Female Patients aged 12 to 50 years with a diagnosis of asthma for at least 6 months before screening
- •Baseline FEV1 of 60% to \>100% of predicted
- •Demonstrate a decrease in FEV1 of 15% or greater from baseline after standardized stepped exercise challenge testing
- •Taking a constant dose of low-medium dose inhaled steroids for at least 30 days before screening of either:
- •fluticasone, 88 - 440 mcg/d via MDI or 100 to 500 mcg/d via DPI
- •beclomethasone HFA 80 to 480 mcg/day
- •budesonide DPI 180 to 1200 mcg/ d
- •flunisolide 500 to 2000 mcg/d
- •flunisolide HFA 320 to 640 mcg/d
- •mometasone 200 to 800 mcg/d
Exclusion Criteria
- •Patients already on LABAs, systemic corticosteroids, or other combination inhaled steroids/LABA medications.
- •Patients not able to safely complete an exercise challenge due to physical constraints outside of their respiratory status.
- •Patients who are pregnant or plan to become pregnant during the study period.
- •Patients with a history of hypersensitivity reaction to either formoterol or budesonide.
- •Patients with any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.
- •Patients with planned hospitalization during the study
- •Current Smokers or those with a history of 10 pack years of tobacco use or more.
Arms & Interventions
Budesonide/Formoterol first
This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide and dummy inhaler.
Intervention: Budesonide/Formoterol
Budesonide/Formoterol first
This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide and dummy inhaler.
Intervention: Budesonide
Budesonide first
This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide/formoterol and dummy inhaler.
Intervention: Budesonide/Formoterol
Budesonide first
This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide/formoterol and dummy inhaler.
Intervention: Budesonide
Outcomes
Primary Outcomes
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))