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

NCT01070888 | Terminated Phase 4 Results DMC

• 1 other identifier: 08080372
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Exercise Induced Asthma

Keywords

Asthma; Exercise Induced Asthma

Outcome Measures

Primary Outcomes (1)

• 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))

  8 weeks

Study Arms (2)

Budesonide/Formoterol first

EXPERIMENTAL

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; Drug: Budesonide

Budesonide first

ACTIVE COMPARATOR

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; Drug: Budesonide

Interventions

Budesonide/Formoterol DRUG

Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks

Also known as: Symbicort

Budesonide first; Budesonide/Formoterol first

Budesonide DRUG

Budesonide 180mcg, 2 puffs twice daily for 2 weeks

Also known as: Pulmicort

Budesonide first; Budesonide/Formoterol first

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 24267370 DERIVED

MeSH Terms

Conditions

Asthma, Exercise-Induced; Asthma

Interventions

Budesonide, Formoterol Fumarate Drug Combination; Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Wanda Phipatanakul
• Organization: Boston Children's Hospital

wanda.phipatanakul@childrens.harvard.edu

857-218-5336

Study Officials

• Wanda Phipatanakul, MD,MS

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Jonathan M Gaffin, MD

  Boston Children's Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study PI

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 7, 2021
• Results First Posted: December 30, 2014

Record last verified: 2021-07

Locations

US (2)