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”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Study Primary Completion Date: March 2011

Intervention(s) in this Clinical Trial

• Drug: Budesonide/Formoterol
  • Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
• Drug: Budesonide
  • Budesonide 180mcg, 2 puffs twice daily for 2 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Budesonide/Formoterol
  • This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.
• Active Comparator: Budesonide
  • This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.

Primary Measures

• Maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period of budesonide alone
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• The change from baseline in morning PEFR during the 2 weeks of treatment,
  • Time Frame: 8
    Safety Issue?: No
• change in the percentage of albuterol rescue-free days
  • Time Frame: 8 weeks
    Safety Issue?: No
• time to return to within 5% of pre-exercise value
  • Time Frame: 8 weeks
    Safety Issue?: No
• Difference between eNO values between treatment groups and within groups from run-in to completion of the study.
  • Time Frame: 8 weeks
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Children's Hospital Boston

Overall Clinical Trial Officials and Contacts

Wanda Phipatanakul, MD,MS Principal Investigator Children's Hospital Boston  

Overall Contact: Jonathan M Gaffin, MD 857-218-4803 jonathan.gaffin@childrens.harvard.edu

Information obtained from ClinicalTrials.gov on September 02, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01070888

Study ID Number: 08080372

ClinicalTrials.gov Identifier: NCT01070888

Health Authority: United States: Institutional Review Board