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

University of New Mexico (UNM)

Status and phase: Withdrawn; Phase 3

Conditions: Exercise-induced Bronchospasm

Treatments: Drug: formoterol; Drug: placebo; Drug: arformoterol

Study type: Interventional

Funder types: Other

Identifiers

NCT00662779

5-MO1-RR-00997 (Other Identifier)

ASRC948

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder

Treatment:

Drug: arformoterol

2

Active Comparator group

Description:

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

Treatment:

Drug: formoterol

3

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo