Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Hospital Boston
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: May 9, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | June 2013 |
| 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:
- 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.
Contacts and Locations
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
| 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: | May 9, 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 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 22, 2013