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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1172-2297 | Registry Identifier | WHO |
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| Name | Class |
|---|---|
| Nycomed GmbH | UNKNOWN |
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The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study provides further data on safety and tolerability of ciclesonide.
The drug being tested is called ciclesonide. This study looked at the safety and efficacy of inhaled ciclesonide in children with asthma. The study enrolled 1080 patients.
Participants were randomly assigned to 1 of 4 treatment groups which were undisclosed to the patient and study doctor during the study:• Ciclesonide 40 µg, 80 µg or 160 µg • Placebo- this is similar to study drug but has no active ingredient. Ciclesonide was inhaled via a metered-dose inhaler (MDI with HFA-134a propellant), with or without spacer, once daily in the evening throughout the study. All participants were asked to document daily AM and PM peak expiratory flow (PEF), daytime and nighttime asthma symptom scores and number of puffs of rescue medicine in an electronic diary. This multi-centre trial was conducted worldwide. The overall time to participate in this study was 20 weeks. Participants made multiple visits to the clinic plus a final visit 30 days after the last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciclesonide 40 µg | Active Comparator | Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
| Ciclesonide 80 µg | Active Comparator | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
| Ciclesonide 160 µg | Active Comparator | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
| Placebo | Placebo Comparator | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug | inhaled Ciclesonide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Morning Peak Expiratory Flow (PEF) | PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. Last observation carried forward. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Event of Lack of Efficacy (LOE) by Week 12 | Kaplan Meier Estimates of the probability of not experiencing LOE by Week 12 was measured. LOE was reached if any of the following criteria occurred during the treatment period: • asthma exacerbation (a worsening of asthma symptoms requiring a change in medication; • nocturnal awakenings due to asthma on any 4 or more nights during any 7-consecutive-day period; • use of more than 8 puffs/day of salbutamol on any 4 or more days during any 7-consecutive-day period; • decrease in morning PEF to <80% of randomization value on any 4 consecutive days during the treatment period. |
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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 | Plovdiv | 4000 | Bulgaria | |||
| Altana Pharma/Nycomed |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20619624 | Derived | Pedersen S, Potter P, Dachev S, Bosheva M, Kaczmarek J, Springer E, Dunkel J, Engelstatter R. Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: the RAINBOW study. Respir Med. 2010 Nov;104(11):1618-28. doi: 10.1016/j.rmed.2010.06.012. Epub 2010 Jul 8. |
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Children with a diagnosis of asthma were enrolled equally in 1 of 4 treatment groups, once a day placebo, 40 µg, 80 µg or 160 µg ciclesonide.
Participants took part in the study at 110 investigative sites in Bulgaria, Germany, Hungary, Poland, Romania, Russia, South Africa, Spain, and Ukraine from 29 September 2006 to 17 August 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ciclesonide 40 µg | Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Ciclesonide placebo-matching inhaler |
|
| Salbutamol | Drug | Salbutamol inhalation powder |
|
| 12 weeks |
| Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation | Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, morning (am) PEF and PEF fluctuation. The median percentage of days with asthma control is presented. | 28 days prior to last visit (Up to 12 Weeks) |
| Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1) | Spirometry was performed according to local standards. FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Higher change numbers indicate better lung function. | Baseline and Week 12 |
| Change From Baseline in Lung Function Variable PEF by Spirometry | Spirometry was performed according to local standards. PEF is the maximum speed of expiration. Analysis was ANCOVA with factors value at Baseline, treatment, age, sex, center pool, ICS pretreatment, spacer use and asthma severity. Higher change numbers indicate better lung function. | Baseline and Week 12 |
| Change From Baseline in Morning PEF From Diary | PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis. | Baseline and Weeks 1 thru 12 |
| Change From Baseline in Evening PEF From Diary | PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis. | Baseline and Week 12 |
| Change From Baseline in Diurnal PEF Fluctuations | PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. A negative change from Baseline indicates improvement. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis. | Baseline and Week 12 |
| Change in Asthma Symptom Total Score | Measurements of both nighttime and daytime asthma symptoms were assessed on a daily basis by the patient in the electronic diary, according to the following scales: Nighttime Asthma Score using a 5 point scale: 0=no asthma symptoms, slept through the night to 4=bad night, awake most of the night because of asthma. Daytime Asthma Score using a 5 point scale: 0=very well, no asthma symptoms to 4=asthma very bad, unable to carry out daily activities as usual. Total possible overall daily score range from 0(best) to 4 (worst). A negative change from Baseline indicated improvement. | Baseline and Week 12 |
| Change in Use of Rescue Medications | The daily use of rescue medication (salbutamol) was recorded in the electronic diary in the morning and the evening. A negative change from Baseline indicates improvement. | Baseline and Week 12 |
| Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF | Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, and morning (am) PEF. The median percentage of days with asthma control is presented. | 28 days prior to last visit (Up to 12 Weeks) |
| Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score | PAQLQS is a disease specific instrument to assess the impact of asthma on the patient's quality of life. The PAQLQS consists of 23 items in 3 domains evaluating activity limitations, symptoms and emotional function. Patients answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment) about their experience during the previous week. Total possible score ranging from 23 (worst) to 161(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. | Baseline and Week 12 |
| Change From Baseline in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall | PACQLQ assesses the impact of the child's asthma on the quality of life of the caregiver. The PACQLQ consists of 13 items in 2 domains evaluating activity limitations and emotional function. Caregivers answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment about their experience during the previous week. Total possible score ranging from 13 (worst) to 91(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. | Baseline and Week 12 |
| Plovdiv |
| 4002 |
| Bulgaria |
| Altana Pharma/Nycomed | Rousse | 7004 | Bulgaria |
| Altana Pharma/Nycomed | Sofia | 1431 | Bulgaria |
| Altana Pharma/Nycomed | Vama | 9010 | Bulgaria |
| Altana Pharma/Nycomed | Dresden | 1067 | Germany |
| Altana Pharma/Nycomed | Freising | 85354 | Germany |
| Altana Pharma/Nycomed | Fulda | 36039 | Germany |
| Altana Pharma/Nycomed | Homburg | 66424 | Germany |
| Altana Pharma/Nycomed | Kassel | 34121 | Germany |
| Altana Pharma/Nycomed | Leipzig | 4207 | Germany |
| Altana Pharma/Nycomed | Mannheim | 68167 | Germany |
| Altana Pharma/Nycomed | Marburg | 35037 | Germany |
| Altana Pharma/Nycomed | München | 80939 | Germany |
| Altana Pharma/Nycomed | Rosenheim | 83026 | Germany |
| Altana Pharma/Nycomed | Schwäbisch Hall | 74523 | Germany |
| Altana Pharma/Nycomed | Welzheim | 73642 | Germany |
| Altana Pharma/Nycomed | Wesel | 46483 | Germany |
| Altana Pharma/Nycomed | Budapest | 1089 | Hungary |
| Altana Pharma/Nycomed | Budapest | 1121 | Hungary |
| Altana Pharma/Nycomed | Debrecen | 4012 | Hungary |
| Altana Pharma/Nycomed | Jászberény | 5100 | Hungary |
| Altana Pharma/Nycomed | Kiskunhalas | 6400 | Hungary |
| Altana Pharma/Nycomed | Miskolc | 3501 | Hungary |
| Altana Pharma/Nycomed | Mosdós | 7257 | Hungary |
| Altana Pharma/Nycomed | Mosonmagyaróvár | 9200 | Hungary |
| Altana Pharma/Nycomed | Pécs | 7624 | Hungary |
| Altana Pharma/Nycomed | Szeged | 6720 | Hungary |
| Altana Pharma/Nycomed | Inowrocław | 88-100 | Poland |
| Altana Pharma/Nycomed | Lodz | 90-141 | Poland |
| Altana Pharma/Nycomed | Lodz | 93-513 | Poland |
| Altana Pharma/Nycomed | Lublin | 20-093 | Poland |
| Altana Pharma/Nycomed | Poznan | 60-693 | Poland |
| Altana Pharma/Nycomed | Torun | 87-100 | Poland |
| Altana Pharma/Nycomed | Warsaw | 01-211 | Poland |
| Altana Pharma/Nycomed | Warsaw | 03-924 | Poland |
| Altana Pharma/Nycomed | Zawadzkie | 46-059 | Poland |
| Altana Pharma/Nycomed | Brasov | 500063 | Romania |
| Altana Pharma/Nycomed | Bucharest | 11025 | Romania |
| Altana Pharma/Nycomed | Bucharest | 11743 | Romania |
| Altana Pharma/Nycomed | Bucharest | 20395 | Romania |
| Altana Pharma/Nycomed | Bucharest | 22102 | Romania |
| Altana Pharma/Nycomed | Bucharest | 22444 | Romania |
| Altana Pharma/Nycomed | Bucharest | 41451 | Romania |
| Altana Pharma/Nycomed | Cluj-Napoca | 400217 | Romania |
| Altana Pharma/Nycomed | Cluj-Napoca | 400371 | Romania |
| Altana Pharma/Nycomed | Craiova | 200341 | Romania |
| Altana Pharma/Nycomed | Galati | 800487 | Romania |
| Altana Pharma/Nycomed | Iași | 700309 | Romania |
| Altana Pharma/Nycomed | Sibiu | 550166 | Romania |
| Altana Pharma/Nycomed | Chelyabinsk | Russia |
| Altana Pharma/Nycomed | Ivanovo | Russia |
| Altana Pharma/Nycomed | Kislovodsk | 357703 | Russia |
| Altana Pharma/Nycomed | Moscow | 105077 | Russia |
| Altana Pharma/Nycomed | Moscow | 115446 | Russia |
| Altana Pharma/Nycomed | Moscow | 115478 | Russia |
| Altana Pharma/Nycomed | Moscow | 117513 | Russia |
| Altana Pharma/Nycomed | Moscow | 119049 | Russia |
| Altana Pharma/Nycomed | Moscow | 119526 | Russia |
| Altana Pharma/Nycomed | Moscow | 119991 | Russia |
| Altana Pharma/Nycomed | Moscow | 125412 | Russia |
| Altana Pharma/Nycomed | Moscow | 129090 | Russia |
| Altana Pharma/Nycomed | Moscow | Russia |
| Altana Pharma/Nycomed | Murmansk | 183047 | Russia |
| Altana Pharma/Nycomed | Novosibirsk | 630091 | Russia |
| Altana Pharma/Nycomed | Rostov-on-Don | 1344068 | Russia |
| Altana Pharma/Nycomed | Saint Petersburg | 191036 | Russia |
| Altana Pharma/Nycomed | Saint Petersburg | 191123 | Russia |
| Altana Pharma/Nycomed | Saint Petersburg | 192212 | Russia |
| Altana Pharma/Nycomed | Saint Petersburg | 193144 | Russia |
| Altana Pharma/Nycomed | Saint Petersburg | 194100 | Russia |
| Altana Pharma/Nycomed | Saint Petersburg | 194156 | Russia |
| Altana Pharma/Nycomed | Saint Petersburg | 196084 | Russia |
| Altana Pharma/Nycomed | Saint Petersburg | 196650 | Russia |
| Altana Pharma/Nycomed | Saint Petersburg | 198205 | Russia |
| Altana Pharma/Nycomed | Saint Petersburg | 199053 | Russia |
| Altana Pharma/Nycomed | Saint Petersburg | Russia |
| Altana Pharma/Nycomed | Samara | 443000 | Russia |
| Altana Pharma/Nycomed | Smolensk | Russia |
| Altana Pharma/Nycomed | Tomsk | Russia |
| Altana Pharma/Nycomed | Vladimir | Russia |
| Altana Pharma/Nycomed | Voronezh | Russia |
| Altana Pharma/Nycomed | Bellville - Cape Town - | 7530 | South Africa |
| Altana Pharma/Nycomed | Bloemfontein | 9301 | South Africa |
| Altana Pharma/Nycomed | Cape Town | 7937 | South Africa |
| Altana Pharma/Nycomed | Centurion | 157 | South Africa |
| Altana Pharma/Nycomed | Durban | 3630 | South Africa |
| Altana Pharma/Nycomed | Durban, Amanzimtoti | 4126 | South Africa |
| Altana Pharma/Nycomed | Gezina, Pretoria | 84 | South Africa |
| Altana Pharma/Nycomed | Morningside, Sandton | 2196 | South Africa |
| Altana Pharma/Nycomed | Mowbray, Cape Town | 7925 | South Africa |
| Altana Pharma/Nycomed | New Redruth, Alberton | 1450 | South Africa |
| Altana Pharma/Nycomed | Panorama / RSA-Cape Town | 7500 | South Africa |
| Altana Pharma/Nycomed | Somerset West | 7130 | South Africa |
| Altana Pharma/Nycomed | Westville | 3630 | South Africa |
| Altana Pharma/Nycomed | Wynberg | 7945 | South Africa |
| Altana Pharma/Nycomed | Barcelona | 8003 | Spain |
| Altana Pharma/Nycomed | Barcelona | 8035 | Spain |
| Altana Pharma/Nycomed | Barcelona | 8222 | Spain |
| Altana Pharma/Nycomed | Esplugues de Llobregat | 8950 | Spain |
| Altana Pharma/Nycomed | Leganés | 28911 | Spain |
| Altana Pharma/Nycomed | Madrid | 28006 | Spain |
| Altana Pharma/Nycomed | Madrid | 28009 | Spain |
| Altana Pharma/Nycomed | Madrid | 28040 | Spain |
| Altana Pharma/Nycomed | Madrid | 28041 | Spain |
| Altana Pharma/Nycomed | Manresa | 8240 | Spain |
| Altana Pharma/Nycomed | Sabadell (Barcelona) | 8208 | Spain |
| Altana Pharma/Nycomed | Tarrasa | 8211 | Spain |
| Altana Pharma/Nycomed | Dnipropetrovsk | 49101 | Ukraine |
| Altana Pharma/Nycomed | Donetsk | 83017 | Ukraine |
| Altana Pharma/Nycomed | Donetsk | 83045 | Ukraine |
| Altana Pharma/Nycomed | Kharkiv | 61051 | Ukraine |
| Altana Pharma/Nycomed | Kiev | 3680 | Ukraine |
| Altana Pharma/Nycomed | Kyiv | 1135 | Ukraine |
| Altana Pharma/Nycomed | Kyiv | 2125 | Ukraine |
| Altana Pharma/Nycomed | Kyiv | 4050 | Ukraine |
| Altana Pharma/Nycomed | Lviv | 79059 | Ukraine |
| Altana Pharma/Nycomed | Odesa | 65031 | Ukraine |
| Altana Pharma/Nycomed | Poltava | 36011 | Ukraine |
| Altana Pharma/Nycomed | Simferopol | 95004 | Ukraine |
| Altana Pharma/Nycomed | Vinnytsia | Ukraine |
| Altana Pharma/Nycomed | Zaporizhzhya | 69063 | Ukraine |
| FG001 | Ciclesonide 80 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| FG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| FG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| Randomized, Not Treated |
|
| Actual Treatment Received |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set includes all randomized participants who received at least one dose of study drug, as treated.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ciclesonide 40 µg | Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| BG001 | Ciclesonide 80 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| BG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| BG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| BG004 | 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Duration of Asthma | Mean | Standard Deviation | months |
| |||||||||||||||
| Inhaled Glucocorticosteroids (ICS) Pretreatment | Number | participants |
| ||||||||||||||||
| ICS Pretreatment Dose | The number of participants with ICS pretreatment dose data is 200, 204, 199 and 102 in each treatment arm, respectively. | Mean | Standard Deviation | µg/day |
| ||||||||||||||
| Asthma Severity According to Global Initiative for Asthma (GINA) | Number | 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 | Change From Baseline in Morning Peak Expiratory Flow (PEF) | PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. Last observation carried forward. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. | Posted | Least Squares Mean | Standard Error | liters/minute | Baseline and Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Event of Lack of Efficacy (LOE) by Week 12 | Kaplan Meier Estimates of the probability of not experiencing LOE by Week 12 was measured. LOE was reached if any of the following criteria occurred during the treatment period: • asthma exacerbation (a worsening of asthma symptoms requiring a change in medication; • nocturnal awakenings due to asthma on any 4 or more nights during any 7-consecutive-day period; • use of more than 8 puffs/day of salbutamol on any 4 or more days during any 7-consecutive-day period; • decrease in morning PEF to <80% of randomization value on any 4 consecutive days during the treatment period. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. | Posted | Number | Percent | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation | Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, morning (am) PEF and PEF fluctuation. The median percentage of days with asthma control is presented. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. | Posted | Median | Full Range | percentage of days | 28 days prior to last visit (Up to 12 Weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1) | Spirometry was performed according to local standards. FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Higher change numbers indicate better lung function. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. | Posted | Least Squares Mean | Standard Error | liters | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Lung Function Variable PEF by Spirometry | Spirometry was performed according to local standards. PEF is the maximum speed of expiration. Analysis was ANCOVA with factors value at Baseline, treatment, age, sex, center pool, ICS pretreatment, spacer use and asthma severity. Higher change numbers indicate better lung function. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last Observation carried forward. | Posted | Least Squares Mean | Standard Error | liters/minute | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning PEF From Diary | PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. | Posted | Least Squares Mean | Standard Error | liters/minute | Baseline and Weeks 1 thru 12 |
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| Secondary | Change From Baseline in Evening PEF From Diary | PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | liters/minute | Baseline and Week 12 |
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| Secondary | Change From Baseline in Diurnal PEF Fluctuations | PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. A negative change from Baseline indicates improvement. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. | Posted | Mean | Standard Deviation | percent change | Baseline and Week 12 |
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| Secondary | Change in Asthma Symptom Total Score | Measurements of both nighttime and daytime asthma symptoms were assessed on a daily basis by the patient in the electronic diary, according to the following scales: Nighttime Asthma Score using a 5 point scale: 0=no asthma symptoms, slept through the night to 4=bad night, awake most of the night because of asthma. Daytime Asthma Score using a 5 point scale: 0=very well, no asthma symptoms to 4=asthma very bad, unable to carry out daily activities as usual. Total possible overall daily score range from 0(best) to 4 (worst). A negative change from Baseline indicated improvement. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 12 |
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| Secondary | Change in Use of Rescue Medications | The daily use of rescue medication (salbutamol) was recorded in the electronic diary in the morning and the evening. A negative change from Baseline indicates improvement. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last Observation carried forward. | Posted | Mean | Standard Deviation | puffs/day | Baseline and Week 12 |
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| Secondary | Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF | Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, and morning (am) PEF. The median percentage of days with asthma control is presented. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. | Posted | Median | Full Range | percentage of days | 28 days prior to last visit (Up to 12 Weeks) |
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| Secondary | Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score | PAQLQS is a disease specific instrument to assess the impact of asthma on the patient's quality of life. The PAQLQS consists of 23 items in 3 domains evaluating activity limitations, symptoms and emotional function. Patients answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment) about their experience during the previous week. Total possible score ranging from 23 (worst) to 161(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall | PACQLQ assesses the impact of the child's asthma on the quality of life of the caregiver. The PACQLQ consists of 13 items in 2 domains evaluating activity limitations and emotional function. Caregivers answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment about their experience during the previous week. Total possible score ranging from 13 (worst) to 91(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. | Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
|
First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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 | Ciclesonide 40 µg | Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. | 4 | 305 | 49 | 305 | ||
| EG001 | Ciclesonide 80 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. | 5 | 312 | 45 | 312 | ||
| EG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. | 2 | 310 | 45 | 310 | ||
| EG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. | 1 | 146 | 14 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA version 10.1 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA version 10.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 10.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 10.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA version 10.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 10.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 10.1 | Systematic Assessment |
| |
| Tonsillitis streptococcal | Infections and infestations | MedDRA version 10.1 | Systematic Assessment |
| |
| Open wound | Injury, poisoning and procedural complications | MedDRA version 10.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA version 10.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA version 10.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 10.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 10.1 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C120481 | ciclesonide |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided
| Male |
|
| non-Caucasian |
|
| Germany |
|
| Hungary |
|
| Poland |
|
| Romania |
|
| Russian Federation |
|
| South Africa |
|
| Spain |
|
| Ukraine |
|
| No |
|
| Mild |
|
| Moderate |
|
| Severe |
|
Baseline value and age as covariates. One-sided p-value, significance level 2.5%. |
| 0.0148 |
| Least Square Means Difference |
| 9.4 |
| Standard Error of the Mean |
| 4.3 |
| 2-Sided |
| 95 |
| 0.9 |
| 17.8 |
| No |
| Superiority or Other |
| ANCOVA | Baseline value and age as covariates. One-sided p-value, significance level 2.5%. | 0.0028 | Least Squares Means Difference | 12.0 | Standard Error of the Mean | 4.3 | 2-Sided | 95 | 3.5 | 20.4 | No | Superiority or Other |
| OG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| OG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
|
|
| OG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| OG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
|
|
| OG002 |
| Ciclesonide 160 µg |
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| OG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
|
| OG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| OG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
|
| OG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| OG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
|
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
| OG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| OG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
|
| OG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| OG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
|
| OG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| OG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
|
| Ciclesonide 160 µg |
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| OG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
|
| OG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| OG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
|
| OG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| OG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
|
| OG002 | Ciclesonide 160 µg | Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
| OG003 | Placebo | Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. |
|
|