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CompletedNCT00112411Updated Dec 8, 2021

Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

A Phase 2 interventional study of Bronchodilator in Asthma, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 9 sites in United States. Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2021-12-08.

Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
4 Years to 11 Years
Sex
All
01

Study summary

This study is designed to evaluate the single-dose effectiveness of two bronchodilator inhalers given at two dose levels in pediatric asthma patients.

02

Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

Browse Asthma studies →

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Persistent asthma for a minimum of six months duration that has been stable for at least four weeks
  • Predicted FEV1 60-90%
  • Demonstration of 12% airway reversibility

Exclusion criteria

Exclusion Criteria:

  • Continuous requirement for beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, anticholinergics and/or steroids other than those inhaled;
  • Presence of clinically-significant non-asthmatic acute or chronic disease
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double

Interventions

  • DrugBronchodilator
06

Study locations

9 sites
  • Allergy Associates Medical Group, Inc.
    San Diego, California 92120, United States
  • Aeroallergy Research Labs of Savannah, Inc.
    Savannah, Georgia 31409, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • Northeast Medical Research Associates, Inc.
    North Dartmouth, Massachusetts 02747, United States
  • Mississippi Asthma and Allergy Clinic
    Jackson, Mississippi 39202, United States
  • North Carolina Clinical Research
    Raleigh, North Carolina 27607, United States
  • Allergy and Asthma Research Group
    Eugene, Oregon 97401, United States
  • Allergy Associates Research Center
    Portland, Oregon 97213, United States
  • Medical Research Network
    The Woodlands, Texas 77380, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00112411
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Responsible party
Sponsor
First posted
Jun 3, 2005
Start date
Jun 30, 2005
Primary completion
Sep 30, 2005
Completion
Sep 30, 2005
Last update
Dec 8, 2021
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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