NCT00112411

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

9 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2005

Completed
27 days until next milestone

Study Start

First participant enrolled

June 30, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2005

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

June 2, 2005

Last Update Submit

December 1, 2021

Conditions

Asthma

Interventions

BronchodilatorDRUG

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Allergy Associates Medical Group, Inc.

San Diego, California, 92120, United States

Location

Aeroallergy Research Labs of Savannah, Inc.

Savannah, Georgia, 31409, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, 02747, United States

Location

Mississippi Asthma and Allergy Clinic

Jackson, Mississippi, 39202, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Allergy and Asthma Research Group

Eugene, Oregon, 97401, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97213, United States

Location

Medical Research Network

The Woodlands, Texas, 77380, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Bronchodilator Agents

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Autonomic AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Asthmatic AgentsRespiratory System AgentsTherapeutic Uses

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2005

First Posted

June 3, 2005

Study Start

June 30, 2005

Primary Completion

September 30, 2005

Study Completion

September 30, 2005

Last Updated

December 8, 2021

Record last verified: 2021-12

Locations

US(9)