Exercise Induced Bronchospasm in Children

NCT00273689 | Completed Phase 4 DMC

• 1 other identifier: ACCP
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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®). Although both medications are used for treating asthma, we don't know which medicine is better at stopping asthma symptoms caused by exercising.

Conditions

Exercise Induced Bronchospasm

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  immediately after exercise

Study Arms (1)

I

OTHER

This is a crossover trial- Patients get randomly assign to albuterol or singulair and then cross overed to the alternate active medication.

Drug: montelukast vs pretreatment with albuterol; Drug: montelukast

Interventions

montelukast vs pretreatment with albuterol DRUG

montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise

Also known as: Singulair is the brand name for montelukast.

I

montelukast DRUG

Montelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise

Also known as: Brand name for montelukast: Singulair

I

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• History of cardiac dysfunction
• Unable to perform exercise challenge
• Use of montelukast

Sponsors & Collaborators

• University of New Mexico: lead
• American College of Clinical Pharmacy: collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Asthma, Exercise-Induced

Interventions

Albuterol; montelukast

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Hengameh H Raissy, PharmD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• William Kelly, PharmD

  University of New Mexico

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2006
• First Posted: January 9, 2006
• Study Start: December 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 7, 2008

Record last verified: 2008-05

Locations

US (1)