NCT00662779

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

April 16, 2008

Last Update Submit

December 9, 2015

Conditions

Exercise-induced Bronchospasm

Keywords

asthmaexercise induced bronchospasmpreventionEIBchildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    April 2008- April 2010

Study Arms (3)

1

EXPERIMENTAL

15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder

Drug: arformoterol

2

ACTIVE COMPARATOR

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

Drug: formoterol

3

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

arformoterolDRUG

15 mcg arformoterol nebulizer

Also known as: Brand name is Brovana.
1
formoterolDRUG

Formoterol 12 mcg/inhalation, dry powder inhaler

Also known as: Brand name is Foradil
2
placeboDRUG

placebo dry powder capsules ( lactose) and placebo normal saline for nebulization

3

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87107, United States

Location

MeSH Terms

Conditions

Asthma, Exercise-InducedAsthma

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityExercise-Induced AllergiesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Hengameh Raissy, Pharm.D.

    University of New Mexico- Pediatric department

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor, Pediatrics

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 21, 2008

Study Start

April 1, 2008

Primary Completion

March 1, 2009

Study Completion

July 1, 2009

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

US(1)