Asthma Clinical Trial
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
| Verified date | January 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 134 |
| Est. completion date | November 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Akron | Ohio |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Avon | Indiana |
| United States | Research Site | Bay City | Michigan |
| United States | Research Site | Bend | Oregon |
| United States | Research Site | Bensalem | Pennsylvania |
| United States | Research Site | Bismarck | North Dakota |
| United States | Research Site | Boerne | Texas |
| United States | Research Site | Brick | New Jersey |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Chesterfield | Missouri |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | East Providence | Rhode Island |
| United States | Research Site | El Paso | Texas |
| United States | Research Site | Fargo | North Dakota |
| United States | Research Site | Feasterville | Pennsylvania |
| United States | Research Site | Gaffney | South Carolina |
| United States | Research Site | Greer | South Carolina |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Lake Oswego | Oregon |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Mandeville | Louisiana |
| United States | Research Site | McCook | Nebraska |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Muscle Shoals | Alabama |
| United States | Research Site | North Syracuse | New York |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Palmdale | California |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Princeton | New Jersey |
| United States | Research Site | Provo | Utah |
| United States | Research Site | Rapid City | South Dakota |
| United States | Research Site | Rolling Hills Estates | California |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | Scottsbluff | Nebraska |
| United States | Research Site | Shawnee Mission | Kansas |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Stamford | Connecticut |
| United States | Research Site | Waco | Texas |
| United States | Research Site | Watertown | South Dakota |
| United States | Research Site | Wheat Ridge | Colorado |
| United States | Research Site | Wheaton | Maryland |
| United States | Research Site | Wilmington | Delaware |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |
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