A Two-week Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects

January 21, 2011 updated by: AstraZeneca

A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose 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 Act. Twice Daily

The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2 actuations twice daily.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Palmdale, California, United States
        • Research Site
      • Rolling Hills Estates, California, United States
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
      • Wheat Ridge, Colorado, United States
        • Research Site
    • Connecticut
      • Stamford, Connecticut, United States
        • Research Site
    • Delaware
      • Wilmington, Delaware, United States
        • Research Site
    • Florida
      • Miami, Florida, United States
        • Research Site
    • Indiana
      • Avon, Indiana, United States
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States
        • Research Site
    • Kansas
      • Shawnee Mission, Kansas, United States
        • Research Site
    • Louisiana
      • Mandeville, Louisiana, United States
        • Research Site
    • Maryland
      • Wheaton, Maryland, United States
        • Research Site
    • Michigan
      • Bay City, Michigan, United States
        • Research Site
    • Missouri
      • Chesterfield, Missouri, United States
        • Research Site
      • Kansas City, Missouri, United States
        • Research Site
    • Nebraska
      • McCook, Nebraska, United States
        • Research Site
      • Scottsbluff, Nebraska, United States
        • Research Site
    • New Jersey
      • Brick, New Jersey, United States
        • Research Site
      • Princeton, New Jersey, United States
        • Research Site
    • New York
      • North Syracuse, New York, United States
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, United States
        • Research Site
      • Fargo, North Dakota, United States
        • Research Site
    • Ohio
      • Akron, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Bend, Oregon, United States
        • Research Site
      • Lake Oswego, Oregon, United States
        • Research Site
    • Pennsylvania
      • Bensalem, Pennsylvania, United States
        • Research Site
      • Feasterville, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • East Providence, Rhode Island, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
      • Gaffney, South Carolina, United States
        • Research Site
      • Greer, South Carolina, United States
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Research Site
      • Watertown, South Dakota, United States
        • Research Site
    • Texas
      • Boerne, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • El Paso, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • Waco, Texas, United States
        • Research Site
    • Utah
      • Provo, Utah, United States
        • Research Site
    • Washington
      • Spokane, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine whether subjects respond similarly to the Onset of Effect Questionnaire items 2 and 5 when administered post-dose versus pre-dose and does that difference favour a bronchodilator treatment group over a non-bronchodilator treatment group

Secondary Outcome Measures

Outcome Measure
To determine if there is an association between the immediate physiological response to medication and the responses to OEQ items 2 and 5 and to determine what subjects mean when they say they feel their asthma maintenance medication 'working right away

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Tomas LG Andersson, MD, AstraZenenca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

March 16, 2007

First Submitted That Met QC Criteria

March 16, 2007

First Posted (Estimate)

March 20, 2007

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5896C00025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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