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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol pMDI | Drug |
| ||
| Budesonide HFA pMDI | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomas LG Andersson, MD | AstraZenenca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Muscle Shoals | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19995138 | Derived | Leidy NK, Gutierrez B, Lampl K, Uryniak T, O'Brien CD. Can patients with asthma feel inhaler therapy working right away? Two clinical trials testing the effect of timing of assessment on patient perception. J Asthma. 2009 Dec;46(10):1006-12. doi: 10.3109/02770900903301260. |
| Label | URL |
|---|---|
| Related Info | View source |
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| 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 | 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 | Provo | Utah | United States |
| Research Site | Spokane | Washington | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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