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Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB)

NCT00662779 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-12-11

No results posted yet for this study

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.

Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.

Conditions

  • Exercise-induced Bronchospasm

Interventions

DRUG

arformoterol

15 mcg arformoterol nebulizer

DRUG

formoterol

Formoterol 12 mcg/inhalation, dry powder inhaler

DRUG

placebo

placebo dry powder capsules ( lactose) and placebo normal saline for nebulization

Sponsors & Collaborators

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Hengameh Raissy, Pharm.D. · University of New Mexico- Pediatric department

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-03-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00662779 on ClinicalTrials.gov