Exercise Induced AsthmaPhase 4NCT01070888
Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma
A Phase 4 study testing Budesonide/Formoterol and Budesonide in people with Exercise Induced Asthma, run by Boston Children's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Exercise Induced Asthma
- What is being tested?
- Budesonide/Formoterol and Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2010to Apr 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
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
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.
Read the detailed description
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.
- Conditions
- Exercise Induced Asthma
- Being tested
- Budesonide/Formoterol, Budesonide
- Keywords
- Asthma, Exercise Induced Asthma
- Medical subject headings
- Asthma, Exercise-Induced, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/FormoterolDrug
Also called Symbicort
Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
BudesonideDrug
Also called Pulmicort
Budesonide 180mcg, 2 puffs twice daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Budesonide/Formoterol; Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Unable to reach target goal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise Induced AsthmaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Wanda Phipatanakul, Boston Children's Hospital
- Investigators
- Wanda Phipatanakul, MD,MS, Principal investigator, Boston Children's HospitalJonathan M Gaffin, MD, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070888
- Sponsor's protocol ID
- 08080372
- Status last verified
- Jul 2021
- First submitted
- 17 Feb 2010
- Last updated
- 7 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24267370
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01070888
- Acronym / sponsor ID
- 08080372
- Conditions
- Exercise Induced Asthma
- Keywords
- Asthma, Exercise Induced Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to reach target goal
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Feb 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Feb 2010 (estimated)
- Results
- Posted 30 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide/Formoterol first | Experimental | Drug: Budesonide/Formoterol, Drug: BudesonideThis 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 | Drug: Budesonide/Formoterol, Drug: BudesonideThis 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. |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide/FormoterolAlso: SymbicortBudesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks | Drug | Budesonide first, Budesonide/Formoterol first |
| BudesonideAlso: PulmicortBudesonide 180mcg, 2 puffs twice daily for 2 weeks | Drug | Budesonide first, Budesonide/Formoterol first |
Primary outcome
Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide
Time frame: 8 weeks
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))
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24267370Gaffin 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wanda Phipatanakul, MD,MS principal investigator
Boston Children's Hospital
Jonathan M Gaffin, MD study director
Boston Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide/Formoterol and Budesonide in people with Exercise Induced Asthma, run by Boston Children's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01070888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.