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

Condition(s) targeted: Asthma

Intervention: Budesonide/formoterol pMDI (Drug); Budesonide HFA pMDI (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Tomas LG Andersson, MD, Study Director, Affiliation: AstraZenenca

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Research Site, Muscle Shoals, Alabama, United States

Research Site, Little Rock, Arkansas, United States

Research Site, 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, Denver, Colorado, United States

Research Site, Wheat Ridge, Colorado, United States

Research Site, Stamford, Connecticut, United States

Research Site, Wilmington, Delaware, United States

Research Site, Miami, Florida, United States

Research Site, Avon, Indiana, United States

Research Site, Iowa City, Iowa, United States

Research Site, Shawnee Mission, Kansas, United States

Research Site, Mandeville, Louisiana, United States

Research Site, Wheaton, Maryland, United States

Research Site, Bay City, Michigan, United States

Research Site, Chesterfield, Missouri, United States

Research Site, Kansas City, Missouri, United States

Research Site, McCook, Nebraska, United States

Research Site, Scottsbluff, Nebraska, United States

Research Site, Brick, New Jersey, United States

Research Site, Princeton, New Jersey, United States

Research Site, North Syracuse, New York, United States

Research Site, Bismarck, North Dakota, United States

Research Site, Fargo, North Dakota, United States

Research Site, Akron, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Bend, Oregon, United States

Research Site, Lake Oswego, Oregon, United States

Research Site, Bensalem, Pennsylvania, United States

Research Site, Feasterville, Pennsylvania, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, East Providence, Rhode Island, United States

Research Site, Charleston, South Carolina, United States

Research Site, Gaffney, South Carolina, United States

Research Site, Greer, South Carolina, United States

Research Site, Rapid City, South Dakota, United States

Research Site, Watertown, South Dakota, United States

Research Site, San Antonio, Texas, United States

Research Site, Waco, Texas, United States

Research Site, El Paso, Texas, United States

Research Site, Boerne, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, Provo, Utah, United States

Research Site, Spokane, Washington, United States

Starting date: March 2007
Ending date: December 2007
Last updated: January 11, 2008