Asthma Clinical Trial
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
| 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) using a 1 week recall period versus a 1 day recall period.
| Status | Completed |
| Enrollment | 123 |
| Est. completion date | August 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 | Albuquerque | New Mexico |
| United States | Research Site | Bellingham | Washington |
| United States | Research Site | Bowling Green | Kentucky |
| United States | Research Site | Butte | Montana |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Collegeville | Pennsylvania |
| United States | Research Site | Colorado Springs | Colorado |
| United States | Research Site | Council Bluffs | Iowa |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Florence | Kentucky |
| United States | Research Site | Fort Smith | Arkansas |
| United States | Research Site | Greensboro | North Carolina |
| United States | Research Site | Greenville | South Carolina |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Metairie | Louisiana |
| United States | Research Site | Mooresville | North Carolina |
| United States | Research Site | New York | New York |
| United States | Research Site | North Syracuse | New York |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Orange | California |
| United States | Research Site | Papillion | Nebraska |
| United States | Research Site | River Forest | Illinois |
| United States | Research Site | Riverside | California |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Sacramento | California |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Jose | California |
| United States | Research Site | Skillman | New Jersey |
| United States | Research Site | South Burlington | Vermont |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | St. Peters | Missouri |
| United States | Research Site | Summit | New Jersey |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Topeka | Kansas |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Tuscumbia | Alabama |
| United States | Research Site | Union | South Carolina |
| United States | Research Site | Valrico | Florida |
| United States | Research Site | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. |
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