Cystic fibrosis
Conditions
Brief summary
Change from baseline in PsA CFU/g of sputum at 8 weeks of treatment (D57 [EOT])
Detailed description
Change from baseline in lung function (% predicted FEV1) at study visits, Change from baseline in quality of life assessments, using: o Cystic Fibrosis Questionnaire - Revised (CFQ-R) respiratory domain, and o Cystic Fibrosis Respiratory Symptom Diary and Chronic Respiratory Infection Symptom Score (CFRSD-CRISS), Change from baseline in PsA CFU/g of sputum at study visits, Efficacy of BX004 on sputum culture conversion, Incidence of treatment-emergent adverse events and change in vital signs, lung exam, blood tests and spirometry
Interventions
DRUGBX004
DRUGBX004 Placebo
Sponsors
Biomx Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in PsA CFU/g of sputum at 8 weeks of treatment (D57 [EOT]) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in lung function (% predicted FEV1) at study visits, Change from baseline in quality of life assessments, using: o Cystic Fibrosis Questionnaire - Revised (CFQ-R) respiratory domain, and o Cystic Fibrosis Respiratory Symptom Diary and Chronic Respiratory Infection Symptom Score (CFRSD-CRISS), Change from baseline in PsA CFU/g of sputum at study visits, Efficacy of BX004 on sputum culture conversion, Incidence of treatment-emergent adverse events and change in vital signs, lung exam, blood tests and spirometry | — |
Countries
Czechia, France, Germany, Ireland, Italy, Netherlands, Poland, Spain
Outcome results
None listed