Exercise-induced BronchospasmPhase 3EIBNCT00662779
Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB)
A Phase 3 study testing arformoterol and formoterol in people with Exercise-induced Bronchospasm, run by University of New Mexico at 1 site in United States.
Trial summary
It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Exercise-induced Bronchospasm
- What is being tested?
- arformoterol and formoterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jul 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 12-17 years of age
- Physician diagnosed asthma for at least 6 months
- Long term controller medication for at least 4 weeks if any being used
- Females of child-bearing potential agree to use an acceptable form of birth control for the duration of the study
- EIB diagnosed by a positive exercise challenge at screening
- Forced expiratory volume in 1 second (FEV1) greater than 70% of predicted at screening visit
Who cannot join
- History of cardiac dysfunction
- Inability to perform exercise challenge ( i.e., running on treadmill or performing adequate spirometry)
- Upper respiratory infection in the last 4 weeks
- Severe exacerbation, use of oral steroids, or hospitalization in the last 3 months
- Chronic (greater than 2 weeks) use of a Long Acting Beta Agonist (LABA)
- Pregnancy or lactation
- History of paradoxical bronchospasm with any beta-agonist
- Obesity defined as BMI greater than 30 kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87107
About this study
Official title: Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm
It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen.
Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.
Read the detailed description
This study is a randomized, double-blind, double-dummy, crossover clinical trial which will consist of 5 study visits and will last up to 3 weeks.
Fifteen children 12-17 years of age with asthma and EIB, regardless of current asthma therapy will be eligible for this trial.
- Conditions
- Exercise-induced Bronchospasm
- Being tested
- arformoterol, formoterol, placebo
- Keywords
- asthma, exercise induced bronchospasm, prevention, EIB, children
- 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.
arformoterolDrug
Also called Brand name is Brovana.
15 mcg arformoterol nebulizer
formoterolDrug
Also called Brand name is Foradil
Formoterol 12 mcg/inhalation, dry powder inhaler
placeboDrug
placebo dry powder capsules ( lactose) and placebo normal saline for nebulization
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder Receives: Drug: arformoterol |
| 2 | Active comparator | 1 inhalation of formoterol fumarate inhalation powder (12 mcg/inhalation) + 2 ml of normal saline nebulizer Receives: Drug: formoterol |
| 3 | Placebo comparator | 1 inhalation of placebo inhalation powder + 2 ml of normal saline nebulizer Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen.
Measured: April 2008-April 2010
Secondary outcomes (1)
Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.
Measured: April 2008- April 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionJul 2009
Why it stopped: High number of screen failures-couldn't find qualified subjects in timely manner
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-induced BronchospasmStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hengameh Raissy, Pharm.D., University of New Mexico
- Investigators
- Hengameh Raissy, Pharm.D., Principal investigator, University of New Mexico- Pediatric department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662779
- Sponsor's protocol ID
- ASRC948
- Other IDs
- 5-MO1-RR-00997
- Acronym
- EIB
- Status last verified
- Dec 2015
- First submitted
- 16 Apr 2008
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm
- ClinicalTrials.gov ID
- NCT00662779
- Acronym / sponsor ID
- EIB / ASRC948
- Conditions
- Exercise-induced Bronchospasm
- Keywords
- asthma, exercise induced bronchospasm, prevention, EIB, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: High number of screen failures-couldn't find qualified subjects in timely manner
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen.
Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.
Detailed description
This study is a randomized, double-blind, double-dummy, crossover clinical trial which will consist of 5 study visits and will last up to 3 weeks.
Fifteen children 12-17 years of age with asthma and EIB, regardless of current asthma therapy will be eligible for this trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: arformoterol15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder |
| 2 | Active comparator | Drug: formoterol1 inhalation of formoterol fumarate inhalation powder (12 mcg/inhalation) + 2 ml of normal saline nebulizer |
| 3 | Placebo comparator | Drug: placebo1 inhalation of placebo inhalation powder + 2 ml of normal saline nebulizer |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children 12-17 years of age
- Physician diagnosed asthma for at least 6 months
- Long term controller medication for at least 4 weeks if any being used
- Females of child-bearing potential agree to use an acceptable form of birth control for the duration of the study
- EIB diagnosed by a positive exercise challenge at screening
Key exclusion criteria (8 listed)
- History of cardiac dysfunction
- Inability to perform exercise challenge ( i.e., running on treadmill or performing adequate spirometry)
- Upper respiratory infection in the last 4 weeks
- Severe exacerbation, use of oral steroids, or hospitalization in the last 3 months
- Chronic (greater than 2 weeks) use of a Long Acting Beta Agonist (LABA)
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 |
|---|---|---|
| arformoterolAlso: Brand name is Brovana.15 mcg arformoterol nebulizer | Drug | 1 |
| formoterolAlso: Brand name is ForadilFormoterol 12 mcg/inhalation, dry powder inhaler | Drug | 2 |
| placeboplacebo dry powder capsules ( lactose) and placebo normal saline for nebulization | Drug | 3 |
Primary outcome
It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen.
Time frame: April 2008-April 2010
1 secondary outcome
Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.
Time frame: April 2008- April 2010
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
Related trials for Exercise-induced Bronchospasm
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Swiss Paediatric Airway Cohort
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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.
Hengameh Raissy, Pharm.D. principal investigator
University of New Mexico- Pediatric department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing arformoterol and formoterol in people with Exercise-induced Bronchospasm, run by University of New Mexico at 1 site 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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen. (time frame: April 2008-April 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2015.