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:
University of New Mexico
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
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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
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 June 17, 2013