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

This study has been terminated.
(High number of screen failures-couldn't find qualified subjects in timely manner)
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00662779
First received: April 16, 2008
Last updated: August 16, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Exercise-induced Bronchospasm
Drug: arformoterol
Drug: formoterol
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • 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. [ Time Frame: April 2008-April 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler. [ Time Frame: April 2008- April 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: July 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder
Drug: arformoterol
15 mcg arformoterol nebulizer
Other Name: 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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662779

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87107
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Hengameh Raissy, Pharm.D. University of New Mexico- Pediatric department
  More Information

No publications provided

Responsible Party: Hengameh H. Raissy, Pharm.D., School of Medicine, University of New Mexico
ClinicalTrials.gov Identifier: NCT00662779     History of Changes
Other Study ID Numbers: ASRC948, 5-MO1-RR-00997
Study First Received: April 16, 2008
Last Updated: August 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of New Mexico:
asthma
exercise induced bronchospasm
prevention
EIB
children

Additional relevant MeSH terms:
Bronchial Spasm
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014