Exercise Induced Asthma
Conditions
Keywords
Asthma, Exercise Induced Asthma
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.
Interventions
DRUGBudesonide/Formoterol
Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
DRUGBudesonide
Budesonide 180mcg, 2 puffs twice daily for 2 weeks
Sponsors
Brigham and Women's Hospital
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide | 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)) |
Countries
United States
Participant flow
Recruitment details
October 2010 to October 2012
Pre-assignment details
excluded from failed run-in or not qualify by exercise challenge
Participants by arm
| Arm | Count |
|---|---|
| Budesonide First This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.
Budesonide first: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks | 2 |
| 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.
Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks, | 4 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (14 Days) | Adverse Event | 0 | 1 |
| First Intervention (14 Days) | Lost to Follow-up | 0 | 1 |
| Washout (14 Days) | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Budesonide/Formoterol First | Budesonide First | Total |
|---|---|---|---|
| Age, Continuous | 22.5 years | 29.5 years | 24.8 years |
| FEV1 fall % predicted with exercise | 61.1 percent fall in FEV1 STANDARD_DEVIATION 13 | 15.5 percent fall in FEV1 STANDARD_DEVIATION 0.6 | 45.9 percent fall in FEV1 STANDARD_DEVIATION 25.6 |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
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))
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Budesonide First | Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide | -3.1 percentage of fall in FEV1 | Standard Deviation 0 |
| Budesonide/Formoterol First | Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide | -19.4 percentage of fall in FEV1 | Standard Deviation 30.5 |