Design of the PF-ILD trial: a double-blind, randomised, placebo-controlled phase III trial of nintedanib in patients with progressive fibrosing interstitial lung disease
| Autor: | Emmanuelle Clerisme-Beaty, Rozsa Schlenker-Herceg, Simon L.F. Walsh, Hendrik Schmidt, Harold R. Collard, Yoshikazu Inoue, Florence Le Maulf, Athol U. Wells, Luca Richeldi, Kevin R. Flaherty, Vincent Cottin, Kevin K. Brown, Anand Devaraj, William Mezzanotte |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Pulmonary and Respiratory Medicine
Vital capacity medicine.medical_specialty Exacerbation Placebo Interstitial Lung Disease 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine Clinical endpoint Medicine 030212 general & internal medicine rare lung diseases business.industry Interstitial lung disease Guideline interstitial fibrosis medicine.disease 030228 respiratory system chemistry Good clinical practice Physical therapy Nintedanib business |
| Zdroj: | BMJ Open Respiratory Research |
| ISSN: | 2052-4439 |
| Popis: | 600 patients aged ≥18 years will be randomised in a 1:1 ratio to nintedanib or placebo. Patients with diagnosis of IPF will be excluded. The study population will be enriched with two-thirds having a usual interstitial pneumonia-like pattern on HRCT. The primary endpoint is the annual rate of decline in forced vital capacity over 52 weeks. The main secondary endpoints are the absolute change from baseline in King’s Brief Interstitial Lung Disease Questionnaire total score, time to first acute interstitial lung disease exacerbation or death and time to all-cause mortality over 52 weeks. Ethics and dissemination The trial is conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (GCP) and Japanese GCP regulations. Trial registration number NCT02999178. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|