A Phase 4 interventional study of Budesonide/Formoterol and Budesonide in Exercise Induced Asthma, sponsored by Boston Children's Hospital. Terminated at 2 sites in United States. Open to participants aged 12 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by Boston Children's Hospital · Phase 4, Interventional, and Treatment
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.
52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.
This study's enrollment of 6 is below the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.
Browse Asthma, Exercise-Induced studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Taking a constant dose of low-medium dose inhaled for at least 30 days before screening of either:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Drug pages: Budesonide · Formoterol
Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
Also known as: Symbicort
Budesonide 180mcg, 2 puffs twice daily for 2 weeks
Also known as: Pulmicort
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))
Time frame: 8 weeks
October 2010 to October 2012
| Milestone | Budesonide First | Budesonide/Formoterol First |
|---|---|---|
| Started | 2 | 4 |
| Completed | 2 | 2 |
| Not completed | 0 | 2 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Milestone | Budesonide First | Budesonide/Formoterol First |
|---|---|---|
| Started | 2 | 2 |
| Completed | 1 | 2 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Milestone | Budesonide First | Budesonide/Formoterol First |
|---|---|---|
| Started | 1 | 2 |
| Completed | 1 | 2 |
| Not completed | 0 | 0 |
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))
| percentage of fall in FEV1 | Budesonide First | Budesonide/Formoterol First |
|---|---|---|
| Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide | -3.1 ± 0 | -19.4 ± 30.5 |
Collected over Throughout entire study, 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Budesonide/Formoterol | — | 0/5 (0%) | 1/5 (20%) |
| Budesonide | — | 0/4 (0%) | 0/4 (0%) |
| Event | Budesonide/Formoterol | Budesonide |
|---|---|---|
| asthma exacerbationRespiratory, thoracic and mediastinal disorders | 1/5 | 0/4 |
| Age, Continuous(years) | Budesonide First | Budesonide/Formoterol First | Total |
|---|---|---|---|
| Mean | 29.5 (18 to 41) | 22.5 (15 to 33) | 24.8 (15 to 41) |
| Sex: Female, Male(Participants) | Budesonide First | Budesonide/Formoterol First | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 0 | 2 | 2 |
| FEV1 fall % predicted with exercise(percent fall in FEV1) | Budesonide First | Budesonide/Formoterol First | Total |
|---|---|---|---|
| Mean | 15.5 ± 0.6 | 61.1 ± 13.0 | 45.9 ± 25.6 |
The record gives a start of Feb 2010, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2014, 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Budesonide · Formoterol