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

Information source: Children's Hospital Boston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Exercise Induced Asthma

Intervention: Budesonide/Formoterol (Drug); Budesonide (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Children's Hospital Boston

Official(s) and/or principal investigator(s):
Wanda Phipatanakul, MD,MS, Principal Investigator, Affiliation: Children's Hospital Boston
Jonathan M Gaffin, MD, Study Director, Affiliation: Children's Hospital Boston

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.

Clinical Details

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

Primary outcome: Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide

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

Minimum age: 12 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Locations and Contacts

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Children's Hospital Boston, Boston, Massachusetts 02115, United States

Additional Information

Starting date: February 2010
Last updated: December 17, 2014

Page last updated: August 23, 2015

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