search
Back to results

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

Primary Purpose

Exercise Induced Asthma

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Budesonide/Formoterol
Budesonide
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise Induced Asthma focused on measuring Asthma, Exercise Induced Asthma

Eligibility Criteria

12 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's Hospital
  • Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Budesonide/Formoterol first

Budesonide first

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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))

Secondary Outcome Measures

Full Information

First Posted
February 17, 2010
Last Updated
July 2, 2021
Sponsor
Boston Children's Hospital
Collaborators
Brigham and Women's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01070888
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Unable to reach target goal
Study Start Date
February 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Induced Asthma
Keywords
Asthma, Exercise Induced Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Budesonide/Formoterol first
Arm Type
Experimental
Arm Description
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.
Arm Title
Budesonide first
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Budesonide/Formoterol
Other Intervention Name(s)
Symbicort
Intervention Description
Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Pulmicort
Intervention Description
Budesonide 180mcg, 2 puffs twice daily for 2 weeks
Primary Outcome Measure Information:
Title
Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide
Description
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))
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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: fluticasone, 88 - 440 mcg/d via MDI or 100 to 500 mcg/d via DPI beclomethasone HFA 80 to 480 mcg/day budesonide DPI 180 to 1200 mcg/ d flunisolide 500 to 2000 mcg/d flunisolide HFA 320 to 640 mcg/d mometasone 200 to 800 mcg/d 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanda Phipatanakul, MD,MS
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan M Gaffin, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24267370
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs