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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Exercise Induced Asthma

Intervention / Treatment
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* Drug: Budesonide/Formoterol
* Drug: Budesonide


Participation Criteria
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Eligibility Criteria
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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 triamcinolone acetonide 300 to 1500 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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide/Formoterol first<br>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. | Drug: Budesonide/Formoterol<br>* Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks<br>* Other names: Symbicort;Drug: Budesonide<br>* Budesonide 180mcg, 2 puffs twice daily for 2 weeks<br>* Other names: Pulmicort;|
| Active Comparator: Budesonide first<br>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. | Drug: Budesonide/Formoterol<br>* Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks<br>* Other names: Symbicort;Drug: Budesonide<br>* Budesonide 180mcg, 2 puffs twice daily for 2 weeks<br>* Other names: Pulmicort;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide | 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)) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Exercise Induced Asthma