A Two-Week Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly 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: AstraZeneca

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.

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

Primary outcome: 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: 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.

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, Tuscumbia, Alabama, United States

Research Site, Fort Smith, Arkansas, United States

Research Site, Sacramento, California, United States

Research Site, San Jose, California, United States

Research Site, Riverside, California, United States

Research Site, Long Beach, California, United States

Research Site, San Diego, California, United States

Research Site, Orange, California, United States

Research Site, Colorado Springs, Colorado, United States

Research Site, Denver, Colorado, United States

Research Site, Valrico, Florida, United States

Research Site, River Forest, Illinois, United States

Research Site, Council Bluffs, Iowa, United States

Research Site, Wichita, Kansas, United States

Research Site, Topeka, Kansas, United States

Research Site, Florence, Kentucky, United States

Research Site, Bowling Green, Kentucky, United States

Research Site, Metairie, Louisiana, United States

Research Site, St. Louis, Missouri, United States

Research Site, St. Peters, Missouri, United States

Research Site, Butte, Montana, United States

Research Site, Papillion, Nebraska, United States

Research Site, Omaha, Nebraska, United States

Research Site, Las Vegas, Nevada, United States

Research Site, Summit, New Jersey, United States

Research Site, Skillman, New Jersey, United States

Research Site, Albuquerque, New Mexico, United States

Research Site, Rochester, New York, United States

Research Site, New York, New York, United States

Research Site, North Syracuse, New York, United States

Research Site, Greensboro, North Carolina, United States

Research Site, Mooresville, North Carolina, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Tulsa, Oklahoma, United States

Research Site, Collegeville, Pennsylvania, United States

Research Site, Union, South Carolina, United States

Research Site, Spartanburg, South Carolina, United States

Research Site, Greenville, South Carolina, United States

Research Site, Charleston, South Carolina, United States

Research Site, Dallas, Texas, United States

Research Site, South Burlington, Vermont, United States

Research Site, Spokane, Washington, United States

Research Site, Tacoma, Washington, United States

Research Site, Bellingham, Washington, United States

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