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

NCT ID: NCT00662779

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-07-31

Brief Summary

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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

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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

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Exercise-induced Bronchospasm

Keywords

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asthma exercise induced bronchospasm prevention EIB children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder

Group Type EXPERIMENTAL

arformoterol

Intervention Type DRUG

15 mcg arformoterol nebulizer

2

1 inhalation of formoterol fumarate inhalation powder (12 mcg/inhalation) + 2 ml of normal saline nebulizer

Group Type ACTIVE_COMPARATOR

formoterol

Intervention Type DRUG

Formoterol 12 mcg/inhalation, dry powder inhaler

3

1 inhalation of placebo inhalation powder + 2 ml of normal saline nebulizer

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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arformoterol

15 mcg arformoterol nebulizer

Intervention Type DRUG

formoterol

Formoterol 12 mcg/inhalation, dry powder inhaler

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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Brand name is Brovana. Brand name is Foradil

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Hengameh Raissy, Pharm.D.

Research Associate Professor, Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hengameh Raissy, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico- Pediatric department

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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5-MO1-RR-00997

Identifier Type: OTHER

Identifier Source: secondary_id

ASRC948

Identifier Type: -

Identifier Source: org_study_id