Clinical trial NCT01070888: Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Exercise Induced Asthma
Keywords: Asthma
Exercise Induced Asthma
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2010-02-18
Enrollment: 6
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Wanda Phipatanakul, MD,MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Jonathan M Gaffin, MD
role: STUDY_DIRECTOR
References:
citation: Gaffin JM, Bouzaher A, McCown M, Larabee Tuttle K, Israel E, Phipatanakul W. Rethinking the prevalence of exercise-induced bronchoconstriction in patients with asthma. Ann Allergy Asthma Immunol. 2013 Dec;111(6):567-8. doi: 10.1016/j.anai.2013.10.005. Epub 2013 Oct 30. No abstract available.