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Itraconazole Powder
Study to Evaluate Itraconazole Administered as Inhaled Dry Powder in Adults With Asthma and ABPA
Ensayo de Pulmatrix, Inc. en ABPA (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 8
- Centros
- 18
- Fin del objetivo primario
- feb 2024
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en feb 2023.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Low enrollment».
Qué mide
Incidence of Treatment Emergent Adverse Events (TEAEs) (del registro, en inglés) (168 dias)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe goal of this clinical trial is to learn about PUR1900 as an inhaled, antifungal therapeutic for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The main questions it aims to answer are: 1. Is PUR1900 safe and well tolerated in adults with asthma and ABPA? 2. Is there an effect of daily administration of PUR1900 on potential outcome measures in adults with asthma and ABPA? 3. Is there fungal resistance to A. fumigatus? This study includes a 28-day screening period, a 112-day (16-week) treatment period, and a 56-day (8 week) observation period. Participants will take either 40mg of PUR1900, 20 mg of PUR1900 or Placebo for 112 days and complete an eDairy, answer questions about their asthma and complete peak respiratory flow measurements at home. They will come to the clinic approximate once a month during the treatment period and complete study assessments. At the end of the observation period participants will complete one more clinic visit. Participants who complete this study may be given the opportunity to continue on study drug in an open label extension study.
Más ensayos de PULM
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| PUR3100 | Fase 1 | Completado | sep 2022 (real) |
| PUR1800 250 ug | Fase 1 | Completado | dic 2021 (real) |
| PUR1900 | Fase 2 | Interrumpido | jul 2020 (real) |
| Itraconazole Powder | Fase 1 | Completado | jun 2018 (real) |
| PUR0200 | Fase 1 | Completado | mar 2016 (real) |
| RUT058-60 | Fase 1/2 | Interrumpido | jun 2015 (real) |
Todos los de PULM, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05667662), actualizada en abr 2024.