Exercise Induced BronchospasmPhase 4NCT00273689
Exercise Induced Bronchospasm in Children
A Phase 4 study testing montelukast vs pretreatment with albuterol and montelukast in people with Exercise Induced Bronchospasm, run by University of New Mexico at 1 site in United States.
Trial summary
The purpose of the study is to test how well 2 different medications stop asthma symptoms caused by exercising. The two medications that will be tested are "pretreatment with albuterol" and montelukast (Singulair®). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Exercise Induced Bronchospasm
- What is being tested?
- montelukast vs pretreatment with albuterol and montelukast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Sep 2007
- Phase
- Phase 4
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 7-17 years of age
- Physician diagnosed asthma for at least 6 months
- EIB diagnosed by a positive exercise challenge at screening and baseline visits
- Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted at screening and baseline visit
Who cannot join
- History of cardiac dysfunction
- Unable to perform exercise challenge
- Use of montelukast
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: "Pretreatment With Albuterol vs. Montelukast in Exercise Induced Bronchospasm in Children."
The purpose of the study is to test how well 2 different medications stop asthma symptoms caused by exercising. The two medications that will be tested are "pretreatment with albuterol" and montelukast (Singulair®). Although both medications are used for treating asthma, we don't know which medicine is better at stopping asthma symptoms caused by exercising.
Read the detailed description
TThis is a randomized, crossover, placebo controlled trial of 30 patients, 7-17 years old with confirmed EIB. Patients will be randomized to montelukast treatment for at least 3 days or pretreatment with albuterol before an exercise challenge. Villiran and colleagues have shown that the protective effect of montelukast in treating EIB is apparent at day 3 of treatment and comparable to treatment for 4 and 8 weeks.
It is our hypothesis that pretreatment with albuterol will provide superior protection against breakthrough EIB in children with mild asthma compared to montelukast as maintenance therapy added to the current asthma regimen. Secondary aims of this study are to measure the effect of montelukast on leukotriene B4 (LTB4) concentrations as measured in EBC, and on inflammation measured by FeNO level. We hypothesize that since montelukast is a cysteinyl leukotriene receptor antagonist, patients with elevated concentration of LTB4 may have a greater response to this medication. Lastly, patients with elevated FeNO, a measure of airway inflammation respond differently to albuterol than montelukast his study is a randomized, double-blind, double-dummy, crossover clinical trial which will consist of 4 study visits and last up to 3 weeks.
Thirty children 7-17 years of age with asthma and EIB, regardless of current asthma therapy will be eligible for this trial. Patients will receive 3-7 days of therapy with either montelukast (5mg or 10 mg capsule) or placebo tablets. After 3-7 days of therapy the patients will be crossed over to receive the alternative therapy. Exercise challenges will be completed at screening, baseline, visit 3 and visit 4. All patients will have an albuterol metered-dose inhaler (MDI) to be used on an as needed basis for asthma symptoms.
- Conditions
- Exercise Induced Bronchospasm
- Being tested
- montelukast vs pretreatment with albuterol, montelukast
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukast vs pretreatment with albuterolDrug
Also called Singulair is the brand name for montelukast.
montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise
montelukastDrug
Also called Brand name for montelukast: Singulair
Montelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise
| Study group | Role | What they receive |
|---|---|---|
| I | Other | This is a crossover trial- Patients get randomly assign to albuterol or singulair and then cross overed to the alternate active medication. Receives: Drug: montelukast vs pretreatment with albuterol; Drug: montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the comparison of the effect of inhaled albuterol and oral montelukast on EIB as percent attenuation in FEV1 after exercise challenge.
Measured: Fall in FEV1 immediately after exercise
Secondary outcomes (1)
Additional objectives will be to compare the differences in response to montelukast with regard to LTB4 concentrations from EBC and FeNO level
Measured: immediately after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionSep 2007
- Study completionSep 2007
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Clinical Pharmacy
- Investigators
- Hengameh H Raissy, PharmD, Principal investigator, University of New MexicoWilliam Kelly, PharmD, Study director, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273689
- Sponsor's protocol ID
- ACCP
- Status last verified
- May 2008
- First submitted
- 5 Jan 2006
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Pretreatment With Albuterol vs. Montelukast in Exercise Induced Bronchospasm in Children."
- ClinicalTrials.gov ID
- NCT00273689
- Acronym / sponsor ID
- ACCP
- Conditions
- Exercise Induced Bronchospasm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- American College of Clinical Pharmacy
- Study start
- Dec 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 9 Jan 2006 (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.
The purpose of the study is to test how well 2 different medications stop asthma symptoms caused by exercising. The two medications that will be tested are "pretreatment with albuterol" and montelukast (Singulair®). Although both medications are used for treating asthma, we don't know which medicine is better at stopping asthma symptoms caused by exercising.
Detailed description
TThis is a randomized, crossover, placebo controlled trial of 30 patients, 7-17 years old with confirmed EIB. Patients will be randomized to montelukast treatment for at least 3 days or pretreatment with albuterol before an exercise challenge. Villiran and colleagues have shown that the protective effect of montelukast in treating EIB is apparent at day 3 of treatment and comparable to treatment for 4 and 8 weeks.
It is our hypothesis that pretreatment with albuterol will provide superior protection against breakthrough EIB in children with mild asthma compared to montelukast as maintenance therapy added to the current asthma regimen. Secondary aims of this study are to measure the effect of montelukast on leukotriene B4 (LTB4) concentrations as measured in EBC, and on inflammation measured by FeNO level. We hypothesize that since montelukast is a cysteinyl leukotriene receptor antagonist, patients with elevated concentration of LTB4 may have a greater response to this medication. Lastly, patients with elevated FeNO, a measure of airway inflammation respond differently to albuterol than montelukast his study is a randomized, double-blind, double-dummy, crossover clinical trial which will consist of 4 study visits and last up to 3 weeks.
Thirty children 7-17 years of age with asthma and EIB, regardless of current asthma therapy will be eligible for this trial. Patients will receive 3-7 days of therapy with either montelukast (5mg or 10 mg capsule) or placebo tablets. After 3-7 days of therapy the patients will be crossed over to receive the alternative therapy. Exercise challenges will be completed at screening, baseline, visit 3 and visit 4. All patients will have an albuterol metered-dose inhaler (MDI) to be used on an as needed basis for asthma symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Other | Drug: montelukast vs pretreatment with albuterol, Drug: montelukastThis is a crossover trial- Patients get randomly assign to albuterol or singulair and then cross overed to the alternate active medication. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children 7-17 years of age
- Physician diagnosed asthma for at least 6 months
- EIB diagnosed by a positive exercise challenge at screening and baseline visits
- Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted at screening and baseline visit
Key exclusion criteria (3 listed)
- History of cardiac dysfunction
- Unable to perform exercise challenge
- Use of montelukast
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 |
|---|---|---|
| montelukast vs pretreatment with albuterolAlso: Singulair is the brand name for montelukast.montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise | Drug | I |
| montelukastAlso: Brand name for montelukast: SingulairMontelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise | Drug | I |
Primary outcome
The primary outcome will be the comparison of the effect of inhaled albuterol and oral montelukast on EIB as percent attenuation in FEV1 after exercise challenge.
Time frame: Fall in FEV1 immediately after exercise
1 secondary outcome
Additional objectives will be to compare the differences in response to montelukast with regard to LTB4 concentrations from EBC and FeNO level
Time frame: immediately after exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
Related trials for Exercise Induced Bronchospasm
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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 H Raissy, PharmD principal investigator
University of New Mexico
William Kelly, PharmD study director
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing montelukast vs pretreatment with albuterol and montelukast 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 7 May 2008. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome will be the comparison of the effect of inhaled albuterol and oral montelukast on EIB as percent attenuation in FEV1 after exercise challenge. (time frame: Fall in FEV1 immediately after exercise). 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 7 May 2008.