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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1137-3949 | Registry Identifier | WHO |
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The study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15 mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or placebo will be inhaled once daily. The study duration consists of a treatment period of 4 weeks. The study will provide further data on safety of ciclesonide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Ciclesonide 320µg |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug | 320µg Ciclesonide versus Placebo |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given) | 4 weeks | |
| Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment | 4 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed | Basel | 4031 | Switzerland |
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| Label | URL |
|---|---|
| BY9010-CH-101-RDS-2012-10-29.pdf | View source |
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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 |
|---|---|
| C120481 | ciclesonide |
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| Drug |
Placebo |
|
| Level of exhaled nitric oxide after 4 weeks of treatment |
| 4 weeks |
| mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper) | 4 weeks |
| Mean change of ACQ after 4 weeks of treatment | 4 weeks |
| Mean change of AQLQ after 4 weeks of treatment | 4 weeks |
| Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment | 4 weeks |
| Exacerbation rates during the 4 weeks of treatment | 4 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |