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Unable to reach target goal
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/Formoterol | Drug | Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks |
|
| 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 | 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wanda Phipatanakul, MD,MS | Boston Children's Hospital | Principal Investigator |
| Jonathan M Gaffin, MD | Boston Children's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Children's Hospital Boston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24267370 | Derived | 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. |
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excluded from failed run-in or not qualify by exercise challenge
October 2010 to October 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Budesonide First | This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide/formoterol and dummy inhale, 2 inhalations of each, twice daily. Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks |
| FG001 | 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. Subjects will subsequently take blinded budesonide and dummy inhale, 2 inhalations of each, twice daily. Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (14 Days) |
|
| |||||||||||||||||||||
| Washout (14 Days) |
| ||||||||||||||||||||||
| Second Intervention (14 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Budesonide First | This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Budesonide first: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)) | Posted | Mean | Standard Deviation | percentage of fall in FEV1 | 8 weeks |
|
Throughout entire study, 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Budesonide/Formoterol: Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | one subject had an asthma exacerbation requiring ED evaluation during the budesonide formoterol intervention. The subject recovered completely. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wanda Phipatanakul | Boston Children's Hospital | 857-218-5336 | wanda.phipatanakul@childrens.harvard.edu |
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| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D000092202 | Exercise-Induced Allergies |
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| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Budesonide | Drug | Budesonide 180mcg, 2 puffs twice daily for 2 weeks |
|
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| 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. Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks, |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| FEV1 fall % predicted with exercise | Mean | Standard Deviation | percent fall in FEV1 |
|
| OG001 |
| 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, then in the subsequent period take budesonide and dummy inhaler 2 puffs twice daily. Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks |
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Budesonide | This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Budesonide: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/formoterol 180mcg, 2 puffs twice daily for 2 weeks | 0 | 4 | 0 | 4 |
|
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| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D009930 |
| Organic Chemicals |
| D000588 | Amines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |