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| ID | Type | Description | Link |
|---|---|---|---|
| D5254C00620 |
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A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have asthma and are currently being treated with inhaled steroids. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Pulmicort |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Forced Expiratory Volume in 1 second | Week 2, 4 and 8, then at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate. | Week 2, 4 and 8, then at week 12 | |
| Incidence of Adverse Events | Week 2,4 and 8, then at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bertil Andersson | AZ employee | Study Director |
| Lars-Göran Carlsson | AZ employee | Study Director |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
|
| Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration) | 6 or 12 hours post dose |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |