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

Primary Purpose

Exercise-induced Bronchospasm

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
arformoterol
formoterol
placebo
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Exercise-induced Bronchospasm focused on measuring asthma, exercise induced bronchospasm, prevention, EIB, children

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University of New Mexico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder

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

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

Outcomes

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.

Secondary Outcome Measures

Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.

Full Information

First Posted
April 16, 2008
Last Updated
December 9, 2015
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT00662779
Brief Title
Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB)
Acronym
EIB
Official Title
Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
High number of screen failures-couldn't find qualified subjects in timely manner
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-induced Bronchospasm
Keywords
asthma, exercise induced bronchospasm, prevention, EIB, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder
Arm Title
2
Arm Type
Active Comparator
Arm Description
1 inhalation of formoterol fumarate inhalation powder (12 mcg/inhalation) + 2 ml of normal saline nebulizer
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
1 inhalation of placebo inhalation powder + 2 ml of normal saline nebulizer
Intervention Type
Drug
Intervention Name(s)
arformoterol
Other Intervention Name(s)
Brand name is Brovana.
Intervention Description
15 mcg arformoterol nebulizer
Intervention Type
Drug
Intervention Name(s)
formoterol
Other Intervention Name(s)
Brand name is Foradil
Intervention Description
Formoterol 12 mcg/inhalation, dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo dry powder capsules ( lactose) and placebo normal saline for nebulization
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hengameh Raissy, Pharm.D.
Organizational Affiliation
University of New Mexico- Pediatric department
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87107
Country
United States

12. IPD Sharing Statement

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

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