Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

Dose-ranging Double-blind, Placebo-controlled Efficacy Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00112411

Enrollment

Unknown

Registered

2005-06-03

Start date

2005-06-30

Completion date

2005-09-30

Last updated

2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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

Interventions

DRUGBronchodilator

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

4 Years to 11 Years

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026