Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00112411
Collaborator
(none)
9
3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Dose-ranging Double-blind, Placebo-controlled Efficacy Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
Actual Study Start Date
:
Jun 30, 2005
Actual Primary Completion Date
:
Sep 30, 2005
Actual Study Completion Date
:
Sep 30, 2005
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
4 Years
to 11 Years
Sexes Eligible for Study:
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:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Allergy Associates Medical Group, Inc. | San Diego | California | United States | 92120 |
| 2 | Aeroallergy Research Labs of Savannah, Inc. | Savannah | Georgia | United States | 31409 |
| 3 | University of Louisville | Louisville | Kentucky | United States | 40202 |
| 4 | Northeast Medical Research Associates, Inc. | North Dartmouth | Massachusetts | United States | 02747 |
| 5 | Mississippi Asthma and Allergy Clinic | Jackson | Mississippi | United States | 39202 |
| 6 | North Carolina Clinical Research | Raleigh | North Carolina | United States | 27607 |
| 7 | Allergy and Asthma Research Group | Eugene | Oregon | United States | 97401 |
| 8 | Allergy Associates Research Center | Portland | Oregon | United States | 97213 |
| 9 | Medical Research Network | The Woodlands | Texas | United States | 77380 |
Sponsors and Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier:
NCT00112411
Other Study ID Numbers:
- IXR-204-25-167
First Posted:
Jun 3, 2005
Last Update Posted:
Dec 8, 2021
Last Verified:
Dec 1, 2021