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A Two-week Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly in Adult Subjects

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Budesonide/formoterol pMDI
Budesonide HFA pMDI
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Mild asthma, Moderate asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or Female, > 18 years of age
  • Mild to moderate asthma requiring treatment with an inhaled corticosteroid
  • Diagnosis of asthma for at least 6 months

Exclusion Criteria:

  • Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
  • Subjects with severe asthma, as judged by investigator
  • Any significant disease or disorder that may jeopardize a subject's safety

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Outcomes

Primary Outcome Measures

To demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) items 2 and 5 using a 1 week recall period versus a 1 day recall period.

Secondary Outcome Measures

To demonstrate the value to subjects of feeling an asthma maintenance medication begins to work right away; to assess the correlation between subject's responses to weekly/daily Onset of Effect Questionnaires with lung function and with diary variables.

Full Information

First Posted
March 16, 2007
Last Updated
January 21, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00449527
Brief Title
A Two-week Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly in Adult Subjects
Official Title
A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Daily Versus Weekly in Adult Subjects (≥ 18 Years) With Mild to Moderate Asthma, Receiving SYMBICORT® pMDI 80/4.5 μg x 2 Actuations Twice Daily or Budesonide HFA pMDI 80 μg x 2 Actuations Twice Daily
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) using a 1 week recall period versus a 1 day recall period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Mild asthma, Moderate asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Budesonide/formoterol pMDI
Other Intervention Name(s)
Symbicort
Intervention Type
Drug
Intervention Name(s)
Budesonide HFA pMDI
Primary Outcome Measure Information:
Title
To demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) items 2 and 5 using a 1 week recall period versus a 1 day recall period.
Secondary Outcome Measure Information:
Title
To demonstrate the value to subjects of feeling an asthma maintenance medication begins to work right away; to assess the correlation between subject's responses to weekly/daily Onset of Effect Questionnaires with lung function and with diary variables.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female, > 18 years of age Mild to moderate asthma requiring treatment with an inhaled corticosteroid Diagnosis of asthma for at least 6 months Exclusion Criteria: Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular) Subjects with severe asthma, as judged by investigator Any significant disease or disorder that may jeopardize a subject's safety
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas LG Andersson, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tuscumbia
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Fort Smith
State/Province
Arkansas
Country
United States
Facility Name
Research Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
Research Site
City
Orange
State/Province
California
Country
United States
Facility Name
Research Site
City
Riverside
State/Province
California
Country
United States
Facility Name
Research Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
San Jose
State/Province
California
Country
United States
Facility Name
Research Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Valrico
State/Province
Florida
Country
United States
Facility Name
Research Site
City
River Forest
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Council Bluffs
State/Province
Iowa
Country
United States
Facility Name
Research Site
City
Topeka
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Bowling Green
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Florence
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
St. Peters
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Butte
State/Province
Montana
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Papillion
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Research Site
City
Skillman
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Summit
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
North Syracuse
State/Province
New York
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Mooresville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Collegeville
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Union
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
South Burlington
State/Province
Vermont
Country
United States
Facility Name
Research Site
City
Bellingham
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19995138
Citation
Leidy NK, Gutierrez B, Lampl K, Uryniak T, O'Brien CD. Can patients with asthma feel inhaler therapy working right away? Two clinical trials testing the effect of timing of assessment on patient perception. J Asthma. 2009 Dec;46(10):1006-12. doi: 10.3109/02770900903301260.
Results Reference
derived
Links:
URL
http://www.asthmaclinicaltrials.com
Description
Related Info

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A Two-week Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly in Adult Subjects

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