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The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability of ciclesonide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Ciclesonide 160 µg |
|
| 2 | Active Comparator | Fluticasone 100 µg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug | inhaled Ciclesonide 160 µg, once daily in the morning |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PC20 AMP (Post-treatment Compared to Baseline) | Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron | Baseline and 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Δ (FVC/SVC) at PC20 (AMP) | Change between baseline and post-treatment of the ratio of Forced Vital Capacity (FVC) and Slow Vital Capacity at PC20. Measured with either small or large partical size AMP. | Baseline and 5 weeks |
| Safety and Tolerability |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altana Pharma/Nycomed | RB Groningen | 9700 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20595155 | Derived | Cohen J, Postma DS, Douma WR, Vonk JM, De Boer AH, ten Hacken NH. Particle size matters: diagnostics and treatment of small airways involvement in asthma. Eur Respir J. 2011 Mar;37(3):532-40. doi: 10.1183/09031936.00204109. Epub 2010 Jul 1. |
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A total of 101 subjects gave Informed Consent. 64 subjects did not enter or discontinued the study due to various reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ciclesonide | 160 µg, once daily |
| FG001 | Fluticasone | 100 µg, twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fluticasone |
| Drug |
inhaled Fluticasone 100 µg, twice daily |
|
| 5 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ciclesonide | 160 µg, once daily |
| BG001 | Fluticasone | 100 µg, twice daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Statistics for the total value were not available. The cited numbers are the results of manual calculations. | Median | Inter-Quartile Range | years |
| ||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PC20 AMP (Post-treatment Compared to Baseline) | Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron | The analyses on treatment effects were performed on all subjects who reached a PC20<640mg/mL. | Posted | Mean | Standard Deviation | Logarithm (mg/mL) | Baseline and 5 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Δ (FVC/SVC) at PC20 (AMP) | Change between baseline and post-treatment of the ratio of Forced Vital Capacity (FVC) and Slow Vital Capacity at PC20. Measured with either small or large partical size AMP. | Not Posted | Baseline and 5 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety and Tolerability | Not Posted | 5 weeks | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ciclesonide | 160 µg, once daily | 0 | 19 | 2 | 19 | ||
| EG001 | Fluticasone | 100 µg, twice daily | 0 | 18 | 2 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Common cold | Infections and infestations | Systematic Assessment |
| ||
| Pain armpit | General disorders | Systematic Assessment |
| ||
| Inflammation of the throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| 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 |
|---|---|
| C120481 | ciclesonide |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
|
| Post-Treatment PC20 small-particle AMP |
|
| Post-Treatment PC20 large-particle AMP |
|