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

Exercise Induced Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01070888
• Other study ID #: 08080372
• Status: Terminated
• Phase: Phase 4
• Start date: February 2010
• Est. completion date: April 2014

Study information

• Verified date: July 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma, Exercise-Induced
• Exercise Induced Asthma

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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))	8 weeks