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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016757-18 | EudraCT Number |
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The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP) and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung functions in asthmatic children patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF 1535 | Experimental | CHF 1535 (BDP/FF) for 12 weeks |
|
| BDP | Active Comparator | BDP for 12 weeks |
|
| BDP+FF | Active Comparator | free combo BDP+FF for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF 1535 | Drug | CHF 1535 (BDP/FF) for 12 weeks |
| |
| Beclomethasone (BDP) |
| Measure | Description | Time Frame |
|---|---|---|
| pre-dose FEV1 (forced expiratory volume in the first second) | Assessment of lung function parameter as pre-dose FEV1 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient with Asthma symptoms | Patients with Asthma symptoms | 12 weeks |
| FVC (forced vital capacity) | Assessment of lung function parameter as FVC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugenio BARALDI, MD | University of Padova - Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMHAT "Alexandrovska | Plovdiv | 4002 | Bulgaria | |||
| Necker Enfants Malades Hospital |
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| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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| Drug |
Beclomethasone (BDP) for 12 weeks |
|
| Beclomethasone (BDP) + Formoterol Fumarate (FF) | Drug | free combo Beclomethasone (BDP) + FF for 12 weeks |
|
| 12 weeks |
| Rescue medication use | rescue medication used by the patient | 12 weeks |
| PEF (peak expiratory flow) | Assessment of PEF as lung function parameter | 12 weeks |
| Number of patients with adverse events | number of adverse event per patient | 12 weeks |
| Blood parameters | Assessment of standard blood parameters (Hematology and chemistry) | at week 0 and week 12 |
| Heart rate | Assessment of heart rate | 12 weeks |
| Blood pressure | Assessment of blood pressure | 12 weeks |
| Paris |
| 75015 |
| France |
| Drez. Gelb & Knecht | Bretten | 75015 | Germany |
| Micro Care Kft | Szigetvár | 7900 | Hungary |
| G.Gaslini Institute | Genoa | 16147 | Italy |
| Uniwersytetu Medycznego | Lodz | 22 90-153 | Poland |
| Spitalul Clinic Universitar de Urgenta Elias | Bucharest | 011461 | Romania |
| Moscow State Medical University | Moscow | 119435 | Russia |
| NZZ- Detská pneumologická a ftizeologická ambulanci | Dolný Smokovec | 059 81 | Slovakia |
| Hospital de Sabadell | Barcelona | Spain |
| Institute of Pediatrics | Kyiv | 04050 | Ukraine |
| 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 |
|---|---|
| D001507 | Beclomethasone |
| C048053 | alpha-ketoisovalerate dehydrogenase phosphatase |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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