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Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

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Teva Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Asthma

Treatments

Drug: Bronchodilator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00112411
IXR-204-25-167

Details and patient eligibility

About

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

Sex

All

Ages

4 to 11 years old

Volunteers

No Healthy Volunteers

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

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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