TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA
Фаза 3
Завершено
NCT02676076
| Заболевание | Asthma |
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| Фаза | Фаза 3 |
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| Спонсор | Chiesi Farmaceutici S.p.A. |
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| Статус | Завершено |
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| Участники | 1,155 участн. |
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| Вмешательство | CHF 5993 100/6/12.5, CHF 1535 100/6 µg |
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| Дата начала | 17.02.2016 |
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| Дата завершения | 17.05.2018 |
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| Публикация результатов | 26.06.2026 |
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Кратко
Evaluate the superiority of CHF 5993 100/6/12.5 µg Pressurised Metered Dose Inhaler (pMDI) (fixed combination of extrafine beclometasone dipropionate (BDP) plus formoterol fumarate (FF) plus glycopyrronium bromide \[GB\]) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate (BDP) plus formoterol fumarate \[FF\]), with regard to lung functions parameters and rate of exacerbations as well as safety and health economics outcomes, in adult patients with uncontrolled asthma on medium doses of inhaled corticosteroids in combination with long acting ß2 agonists (LABA).
1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
Week 0 (pre-treatment, baseline) to Week 26. · Liter
| CHF 5993 100/6/12.5 µg | 0.185 Liter |
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| CHF 1535 100/6 µg | 0.127 Liter |
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| p-value | 0.008 |
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| Adjusted mean difference | 0.057 (95% CI 0.015–0.099) |
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2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period
Week 0 (pre-treatment, baseline) to Week 52. · events/year
| CHF 5993 100/6/12.5 µg | 1.825 events/year |
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| CHF 1535 100/6 µg | 2.157 events/year |
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| p-value | 0.033 |
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| Adjusted rate ratio | 0.846 (95% CI 0.725–0.987) |
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