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

Sponsor:	Children's Hospital Boston
Collaborator:	Brigham and Women's Hospital
Information provided by:	Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT01070888

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:

MedlinePlus related topics: Asthma Exercise and Physical Fitness

Drug Information available for: Formoterol fumarate Budesonide Formoterol Arformoterol Tartrate

U.S. FDA Resources

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:	June 2012
Estimated Primary Completion Date:	March 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

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

Contacts

Contact: Jonathan M Gaffin, MD	857-218-4803	jonathan.gaffin@childrens.harvard.edu
Contact: Wendy Gordon	617-355-0988	wendy.gordon@childrens.harvard.edu

Locations

United States, Massachusetts
Children's Hospital Boston	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jonathan M Gaffin, MD 857-218-4803 jonathan.gaffin@childrens.harvard.edu
Principal Investigator: Wanda Phipatanakul, MD,MS
Sub-Investigator: Jonathan M Gaffin, MD
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jonathan M Gaffin, MD 857-218-4803 jonathan.gaffin@childrens.harvard.edu
Principal Investigator: Elliot Israel, MD
Sub-Investigator: Jonathan M Gaffin, MD
Sub-Investigator: Michael Wechsler, MD, MMSc

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

Responsible Party:	Wanda Phipatanakul, M.D., M.S., Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT01070888 History of Changes
Other Study ID Numbers:	08080372
Study First Received:	February 17, 2010
Last Updated:	June 22, 2011
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
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 24, 2012