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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Wanda Phipatanakul, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01070888
First received: February 17, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Exercise Induced Asthma
Drug: Budesonide/Formoterol
Drug: Budesonide
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period of budesonide alone [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change from baseline in morning PEFR during the 2 weeks of treatment, [ Time Frame: 8 ] [ Designated as safety issue: No ]
  • change in the percentage of albuterol rescue-free days [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • time to return to within 5% of pre-exercise value [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Difference between eNO values between treatment groups and within groups from run-in to completion of the study. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2010
Estimated Study Completion Date: July 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Budesonide/Formoterol
Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
Other Name: Symbicort
Active Comparator: Budesonide
This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.
Drug: Budesonide
Budesonide 180mcg, 2 puffs twice daily for 2 weeks
Other Name: Pulmicort

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070888

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Brigham and Women's Hospital
Investigators
Principal Investigator: Wanda Phipatanakul, MD,MS Children's Hospital Boston
Study Director: Jonathan M Gaffin, MD Children's Hospital Boston
  More Information

No publications provided by Children's Hospital Boston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wanda Phipatanakul, Study PI, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01070888     History of Changes
Other Study ID Numbers: 08080372
Study First Received: February 17, 2010
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Asthma
Exercise Induced Asthma

Additional relevant MeSH terms:
Asthma
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Budesonide
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on October 16, 2014