Pretreatment with albuterol vs. montelukast in exercise induced bronchospasm in children.
Latest Information Update: 16 Oct 2008
At a glance
- Drugs Salbutamol (Primary) ; Montelukast
- Indications Asthma; Bronchospasm; Exercise-induced asthma
- Focus Therapeutic Use
- 27 Mar 2007 New trial record.
Most Recent Events
Trial Overview
Outcome
Comments
This trial is entitled "Pretreatment with albuterol vs. montelukast in exercise induced bronchospasm in children.". It aims to determine the efficacy of this regimen. The primary outcome was the maximal change in FEV1 (forced volume of expiration in 1 second) after exercise.
Primary Endpoints
Forced expiratory volume in 1 second [1]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| Asthma | treatment | - |
| Bronchospasm | prevention, treatment | - |
| Exercise-induced asthma | prevention | - |
Subjects
- Subject Type patients
-
Number
Planned: 13
Actual: 13
- Sex male & female
- Age Group 7-17 years; adolescent; child
Patient Inclusion Criteria
children 7-17 years of age; physician diagnosed asthma for at least 6 months; exercise-induced brochospasm diagnosed by a positive exercise challenge at screening and baseline visits; forced expiratory volume in 1 second greater than or equal to 70 percent of predicted at screening and baseline visit
Patient Exclusion Criteria
history of cardiac dysfunction; unable to perform exercise challenge; use of montelukast
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT00273689 | ClinicalTrials.gov: US National Institutes of Health |
Organisations
- Affiliations Sanofi
Trial Dates
-
Initiation Dates
Actual : 01 Dec 2005
-
Primary Completion Dates
Actual : 01 Sep 2007
Other Details
- Design crossover; double-blind; randomised
- Phase of Trial Phase II
- Location USA
- Focus Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| Montelukast | Oral | Capsule |
| SalbutamolPrimary Drug | Inhalation | Aerosol |
Montelukast
Montelukast (Dosage: 5-10 mg/day; Route: PO; Formulation: capsule; Frequency: od; Duration: 3-7 days; Patients recieved montelukast for 3-7 days before the exercise challenge.)
Salbutamol
Salbutamol (Dosage: 180 microg/dose; Route: inh; Formulation: aerosol; Duration: 2 doses; Patients took two puffs (90 microg per puff) of a salbutamol metered dose inhaler fifteen minutes before the exercise challenge.)
Results
Therapeutic efficacy
Salbutamol was more effective than montelukast, for the prevention of exercise-induced bronchospasm, in children and adolescents with asthma. After exercise, the maximal change in forced expiratory volume in 1 second (primary endpoint) was significantly reduced following treatment with salbutamol compared with montelukast (0.7% vs 18.3%; p<0.01). [1]
Publications
-
Raissy HH, Harkins M, Kelly F, Kelly HW. Pretreatment with albuterol versus montelukast for exercise-induced bronchospasm in children. Pharmacotherapy 2008;28(3):287-294.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
|
Kelly F
505-272-9889
show details
FMKelly@salud.unm.edu |
University of New Mexico | USA |
| Kelly W | University of New Mexico | USA |
| Raissy HH | University of New Mexico | USA |
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| National Center for Research Resources | Bethesda, Maryland | USA |
| sanofi-aventis |
-
|
-
|
| University of New Mexico | Albuquerque, New Mexico | USA |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 01 Mar 2008 | Other trial event | Results were published in Pharmacotherapy. Updated 16 Oct 2008 |
| 01 Mar 2008 | Endpoint met | Primary endpoint 'Forced expiratory volume in 1 second' has been met. Updated 16 Oct 2008 |
| 07 May 2007 | Status change - active, no longer recruiting | Status changed from recruitin to in progress. Updated 27 Jul 2007 |
| 27 Mar 2007 | New trial record | New trial record. Updated 27 Mar 2007 |
Table of Contents
References
-
Raissy HH, Harkins M, Kelly F, Kelly HW. Pretreatment with albuterol versus montelukast for exercise-induced bronchospasm in children. Pharmacotherapy 2008;28(3):287-294.
PubMed | CrossRef Fulltext -
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