Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| XRP1526 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.
Secondary objective: To assess the safety and tolerability of ciclesonide.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo MDI | Placebo Comparator | double-blind |
|
| Ciclesonide MDI 40 µg BID | Experimental | double-blind |
|
| Ciclesonide MDI 80 µg BID | Experimental | double-blind |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug | Ciclesonide MDI 40 µg BID over twelve weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12. | Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to <12 years only. Least Squares Mean were adjusted for Baseline FEV1, age [yrs], pooled center, previous corticosteroid therapy and holding chamber. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Daily Asthma Symptom Score at Week 12. | Change in total daily asthma symptom score from baseline to week 12. 5-Point, ordinal scale specifying patient's experience of symptoms during day and night from 0 (no symptoms) to 4 (symptoms that prevent the patient from engaging in daily activities or sleep) | Baseline and Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| sanofi-aventis, US | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Hungaria |
The number of subjects in section Participant Flow is related to the number of randomized subjects (= subject who were eligible for treatment period). This number is different to the number of subjects of the Intention to Treat (ITT) population in Outcome Measures. The statistical analyses of the Outcome Measures is related to the ITT population.
Screening period 7-14 days, randomization with subsequent treatment period over 12 weeks
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Metered Dose Inhaler (MDI) | Placebo MDI over twelve weeks (ITT population) |
| FG001 | Ciclesonide MDI 40 µg BID | Ciclesonide MDI 40 µg BID over twelve weeks (ITT population) |
| FG002 | Ciclesonide MDI 80 µg BID | Ciclesonide MDI 80 µg BID over twelve weeks (ITT population) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Metered Dose Inhaler (MDI) | Placebo MDI over twelve weeks (ITT population) |
| BG001 | Ciclesonide MDI 40 µg BID | Ciclesonide MDI 40 µg BID over twelve weeks (ITT population) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12. | Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to <12 years only. Least Squares Mean were adjusted for Baseline FEV1, age [yrs], pooled center, previous corticosteroid therapy and holding chamber. | Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement. The primary analysis was restricted to an age range between 6 and <12 years. | Posted | Least Squares Mean | Standard Error | Percent of predicted FEV1 | Baseline and Week 12 |
|
Not provided
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Metered Dose Inhaler (MDI) | Placebo MDI over twelve weeks (ITT population) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C120481 | ciclesonide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ciclesonide |
| Drug |
Ciclesonide MDI 80 µg BID over twelve weeks |
|
| Placebo | Drug | Placebo MDI over twelve weeks |
|
| Change From Baseline in Use of Albuterol/Salbutamol at Week 12. | Change in albuterol/salbutamol use from baseline to week 12 | Baseline and Week 12 |
| Budapest |
| Hungary |
| Sanofi-Aventis | México | Mexico |
| sanofi-aventis Poland | Warsaw | Poland |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| sanofi-aventis South Africa | Midrand | South Africa |
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Parent/legal guardian withdrawal |
|
| Other |
|
| BG002 | Ciclesonide MDI 80 µg BID | Ciclesonide MDI 80 µg BID over twelve weeks (ITT population) |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Gender | Count of Participants | Participants |
|
| Ciclesonide MDI 40 µg BID |
Ciclesonide MDI 40 µg BID over twelve weeks (ITT population) |
| OG002 | Ciclesonide MDI 80 µg BID | Ciclesonide MDI 80 µg BID over twelve weeks (ITT population) |
|
|
|
| Secondary | Change From Baseline in Total Daily Asthma Symptom Score at Week 12. | Change in total daily asthma symptom score from baseline to week 12. 5-Point, ordinal scale specifying patient's experience of symptoms during day and night from 0 (no symptoms) to 4 (symptoms that prevent the patient from engaging in daily activities or sleep) | Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Use of Albuterol/Salbutamol at Week 12. | Change in albuterol/salbutamol use from baseline to week 12 | Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement. | Posted | Least Squares Mean | Standard Error | Puffs per day | Baseline and Week 12 |
|
|
|
| 1 |
| 172 |
| 53 |
| 172 |
| EG001 | Ciclesonide MDI 40 µg BID | Ciclesonide MDI 40 µg BID over twelve weeks (ITT population) | 1 | 174 | 38 | 174 |
| EG002 | Ciclesonide MDI 80 µg BID | Ciclesonide MDI 80 µg BID over twelve weeks (ITT population) | 4 | 175 | 28 | 175 |
| Forearm fracture | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Electric shock | General disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |