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Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bronchodilator
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

4 Years - 11 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Allergy Associates Medical Group, Inc.
  • Aeroallergy Research Labs of Savannah, Inc.
  • University of Louisville
  • Northeast Medical Research Associates, Inc.
  • Mississippi Asthma and Allergy Clinic
  • North Carolina Clinical Research
  • Allergy and Asthma Research Group
  • Allergy Associates Research Center
  • Medical Research Network

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2005
Last Updated
December 1, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00112411
Brief Title
Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
Official Title
Dose-ranging Double-blind, Placebo-controlled Efficacy Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2005 (Actual)
Primary Completion Date
September 30, 2005 (Actual)
Study Completion Date
September 30, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bronchodilator

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Allergy Associates Medical Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Aeroallergy Research Labs of Savannah, Inc.
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31409
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Northeast Medical Research Associates, Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Mississippi Asthma and Allergy Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Allergy and Asthma Research Group
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Allergy Associates Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Medical Research Network
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States

12. IPD Sharing Statement

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Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

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