Idiopathic Pulmonary Fibrosis
Conditions
Interventions
Danazol
Idiopathic Pulmonary Fibrosis
Telomeres
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Consensus (working) diagnosis of IPF - Age >= 18 - Starting treatment with danazol at St. Antonius Hospital (danazol treatment is offered to patients in the course of regular clinical care when: [1] treatment with both pirfenidone and nintedanib has been given or is not possible; and [2] there is proven clinical (decline in forced vital capacity (FVC) of >5% of predicted) and radiological (worsening of high-resolution computed tomography (HRCT) picture) progression of the disease)
Exclusion criteria
Exclusion criteria: - Concomitant (severe) disease that precludes the ability to participate in the study protocol, or is likely to result in death within 30 days: - Inability to give informed consent - Not eligible for danazol treatment (patients will not be eligible to receive danazol treatment in the course of regular clinical care in case of: [1] severe cardiac, hepatic or renal disease; [2] use of statins metabolized by CYP3A4 (simvastatin, atorvastatin, lovastatin); [3] androgen-dependent tumor (e.g. prostate carcinoma); [4] increased thromboembolic risk, and no adequate prophylactic measures taken; [5] genital neoplasia; [6] porphyria; [7] pregnancy, or of childbearing potential and unwilling to take adequate contraceptive measures during danazol treatment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is difference in yearly decline in lung function between the period prior to danazol treatment and the first year after start of danazol treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are telomere length at baseline compared to that during danazol treatment, haematological parameters at baseline compared to during danazol treatment, survival, radiological qualification of pulmonary fibrosis at baseline compared to during danazol treatment, quality of life at baseline compared to that during danazol treatment, and adverse events during danazol treatment. | — |
Countries
The Netherlands
Outcome results
None listed