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Study in Patients With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Formoterol Fumarate
Sponsored by
Dey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Formoterol, Fumarate

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children with a history of asthma Written guardian approval Exclusion Criteria: Current or recent asthma exacerbation, requiring hospitalization History of smoking Debilitating or systemic and/or life-threatening diseases.

Sites / Locations

  • Research Site
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Outcomes

Primary Outcome Measures

Measure of lung function

Secondary Outcome Measures

Change in lung function, as well as vital signs
Physical Exam results, AE reporting, etc

Full Information

First Posted
September 13, 2005
Last Updated
November 10, 2010
Sponsor
Dey
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1. Study Identification

Unique Protocol Identification Number
NCT00215410
Brief Title
Study in Patients With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dey

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the most safe and effective dose of the investigational drug in comparison with a control drug and placebo.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Formoterol Fumarate
Primary Outcome Measure Information:
Title
Measure of lung function
Secondary Outcome Measure Information:
Title
Change in lung function, as well as vital signs
Title
Physical Exam results, AE reporting, etc

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with a history of asthma Written guardian approval Exclusion Criteria: Current or recent asthma exacerbation, requiring hospitalization History of smoking Debilitating or systemic and/or life-threatening diseases.
Facility Information:
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Research Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Research Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92888
Country
United States
Facility Name
Research Site
City
Vista
State/Province
California
ZIP/Postal Code
92084
Country
United States
Facility Name
Research Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Research Site
City
Oklahoma
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Research Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States

12. IPD Sharing Statement

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Study in Patients With Asthma

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