Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma

Phase 4

Terminated

• Conditions: Exercise Induced Asthma
• Interventions: Drug: Budesonide/Formoterol; Drug: Budesonide

• Registration Number: NCT01070888
• Lead Sponsor: Boston Children's Hospital

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2014-11-19
• Results First Submitted QC: 2014-12-17
• Results First Posted: 2014-12-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Budesonide/Formoterol first	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. The second study period will be budesonide and dummy inhaler.
Budesonide/Formoterol first	Budesonide	This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide and dummy inhaler.
Budesonide first	Budesonide/Formoterol	This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide/formoterol and dummy inhaler.
Budesonide first	Budesonide	This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide/formoterol and dummy inhaler.

Primary Outcome Measures

Name	Time	Method
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))

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States