Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma
Condition: Exercise Induced Asthma
MeSH terms: Asthma; Asthma, Exercise-Induced
Intervention: Budesonide/Formoterol; Budesonide
Intervention description: Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks; Budesonide 180mcg, 2 puffs twice daily for 2 weeks
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 12 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Asthma; Exercise Induced Asthma

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.
    

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:

               1. fluticasone, 88 - 440 mcg/d via MDI or 100 to 500 mcg/d via DPI

               2. beclomethasone HFA 80 to 480 mcg/day

               3. budesonide DPI 180 to 1200 mcg/ d

               4. flunisolide 500 to 2000 mcg/d

               5. flunisolide HFA 320 to 640 mcg/d

               6. mometasone 200 to 800 mcg/d

               7. 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.