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

July 2, 2021 updated by: Wanda Phipatanakul, Boston Children's Hospital

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Budesonide/Formoterol first
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.
Drug: Budesonide/Formoterol
Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
Other Names:
  • Symbicort
Drug: Budesonide
Budesonide 180mcg, 2 puffs twice daily for 2 weeks
Other Names:
  • Pulmicort
ACTIVE_COMPARATOR: Budesonide first
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.
Drug: Budesonide/Formoterol
Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
Other Names:
  • Symbicort
Drug: Budesonide
Budesonide 180mcg, 2 puffs twice daily for 2 weeks
Other Names:
  • Pulmicort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide
Time Frame: 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))
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Wanda Phipatanakul, MD,MS, Boston Children's Hospital
  • Study Director: Jonathan M Gaffin, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (ESTIMATE)

February 18, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08080372

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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