The goal of this clinical trial is to evaluate the safety and tolerability of TMX in adults patients with cystic fibrosis who do not have mutations currently eligible for therapy with modulator drugs.
The main questions it aims to answer is:
. What medical problems do participants have when taking drug TMX?
Participants will:
* Take drug TMX every day for 6 months * Visit the clinic once every 28 days for checkups and tests
Subjects of both sexes, affected by cystic fibrosis, attending the CF Center in Verona
Patients who do not have mutations currently eligible for therapy with CFTR modulator drugs
Age 18 years or older
Predicted forced expiratory volume in 1 second (ppFEV1) ≥ 40% and ≤ 90% (of the predicted value for people of their age, sex, and height) before bronchodilator administration
Patients on any CFTR modulator therapy
Pulmonary exacerbations within 3 weeks before Day 1 (first dose of study drug)
Changes in therapy for lung disease within 3 weeks before Day 1 (first dose of study drug)
Family and/or personal history of thromboembolism and thromboembolic conditions up to 1st-degree relatives
Single group
Tamoxifen Citrate 20Mg Tab
DrugOne tablet per day (20 mg/day), in the morning.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The primary endpoint of this study will be evaluated by calculating between baseline and week 24 the incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs) and treatment discontinuation due to AEs. In addition, frequency of specific, indication-relevant adverse events (e.g., thromboembolic events, elevation of liver enzymes, pulmonary exacerbations) and cumulative AE analyses, such as the number of AEs per patient, will be also evaluated.
Changes in respiratory function values
The relative change from baseline to week 24 in ppFEV1
Changes in pulmonary exacerbation
The number of pulmonary exacerbations up to week 24 and the time to the first pulmonary exacerbation up to week 24
Changes in hospitalizations
The number of hospitalizations for cystic fibrosis lasting \> 24 hours and the time to the first hospitalization for cystic fibrosis
Changes in quality of life
The absolute change in the respiratory domain score of the Cystic Fibrosis Questionnaire-Revised (CFQ-R) (the more the value increases, the greater the perceived well-being)
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This trial is not recruiting at the moment. You can still explore other options:
