Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB) (EIB)
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|ClinicalTrials.gov Identifier: NCT00662779|
Recruitment Status : Withdrawn (High number of screen failures-couldn't find qualified subjects in timely manner)
First Posted : April 21, 2008
Last Update Posted : December 11, 2015
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 or disease||Intervention/treatment||Phase|
|Exercise-induced Bronchospasm||Drug: arformoterol Drug: formoterol Drug: placebo||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||July 2009|
15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder
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
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
placebo dry powder capsules ( lactose) and placebo normal saline for nebulization
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662779
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87107|
|Principal Investigator:||Hengameh Raissy, Pharm.D.||University of New Mexico- Pediatric department|