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Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*) — ORKAMBI  

Cystic Fibrosis Clinical Trial

Official title:
Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*)

Clinical Trial Summary

The purpose of the study is to examine the real-life safety and effectiveness of the novel combination ivacaftor+lumacaftor in eligible patients with cystic fibrosis (CF). All patients with CF were eligible if they were 12 years and older, started ivacaftor+lumacaftor outside of a clinical trial between December 15th 2017 and December 15th 2018 in an accredited CF center in France. Patient followed-up is based on standardized recommendation of the French Cystic Fibrosis Society. Each patient is followed 1 year.

Clinical Trial Description

Each patient is followed one year with visits at months 1, 3, 6 and 12. At each visit, the following data are recorded: - Treatment discontinuation or not. If the treatment was discontinued, reasons for discontinuation - Adverse effects - Lung function (spirometry) - Body mass index - Pulmonary exacerbations (intravenous antibiotics) - Sputum microbiology - Liver enzymes are measured at each visit At the initial and 12 visits, a yearly CF examination is proposed to the patients: - Blood tests - Chest CT scans - Body plethysmography ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03475381
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase
Start date January 22, 2016
Completion date December 31, 2018
View Details
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