Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma
Stopped early · Phase 4
Conditions studied: Exercise Induced Asthma
In brief
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.
Key facts
- Study ID
- NCT01070888
- Run by
- Boston Children's Hospital
- People needed
- 6
- Starts
- 2010-02-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2021-07-07
Who can join
Age: 12 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Children's Hospital Boston — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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