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

Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm

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.

Study Overview

• Status: Withdrawn
• Conditions: Exercise-induced Bronchospasm
• Intervention / Treatment: Drug: arformoterol; Drug: formoterol; Drug: placebo

Detailed 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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87107
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder	Drug: arformoterol; 15 mcg arformoterol nebulizer; Other Names: Brand name is Brovana.
Active Comparator: 2; 1 inhalation of formoterol fumarate inhalation powder (12 mcg/inhalation) + 2 ml of normal saline nebulizer	Drug: formoterol; Formoterol 12 mcg/inhalation, dry powder inhaler; Other Names: Brand name is Foradil
Placebo Comparator: 3; 1 inhalation of placebo inhalation powder + 2 ml of normal saline nebulizer	Drug: placebo; placebo dry powder capsules ( lactose) and placebo normal saline for nebulization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	April 2008-April 2010

Secondary Outcome Measures

Outcome Measure	Time Frame
Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.	April 2008- April 2010

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Hengameh Raissy, Pharm.D., University of New Mexico- Pediatric department

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: April 16, 2008
• First Submitted That Met QC Criteria: April 17, 2008
• First Posted (Estimate): April 21, 2008

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: December 9, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: children; asthma; prevention; exercise induced bronchospasm; EIB
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Bronchial Spasm; Asthma, Exercise-Induced; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Formoterol Fumarate
• Other Study ID Numbers: ASRC948; 5-MO1-RR-00997 (Other Identifier: GCRC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No