Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib (QUALIFY IPF)

Boehringer Ingelheim

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Nintedanib

Study type: Observational

Funder types: Industry

Identifiers

NCT03710824

1199-0355

Details and patient eligibility

About

Multi-center, non-interventional, prospective cohort study aiming to enroll 240 Idiopathic Pulmonary Fibrosis patients receiving treatment with nintedanib in a consecutive manner from 10-12 reference centers across Greece.

Enrollment: 180 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥40 years of age.
• Patients that have signed Informed Consent Form.
• Treatment naive patients with an initial IPF diagnosis no more than 3 months prior to enrolment according to 2011 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines who are initiating treatment with nintedanib (as monotherapy for IPF) the latest on the enrollement day or have initiated treatment with nintedanib (as monotherapy for IPF) within the past 7 days prior to enrolment.
• Patients for whom the decision to prescribe therapy with nintedanib according to the locally approved product's Summary of Product Characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study.
• Patients that are able to read, understand and complete the study specific questionnaires.

Exclusion criteria

• Treatment with nintedanib for more than 7 days prior to study enrolment.
• Patients receiving a combination therapy of nintedanib & pirfenidone for IPF.
• Patients that meet any of the contraindications to the administration of the study drug nintedanib according to the approved SmPC.
• Prior treatment with pirfenidone or other treatment for IPF.
• Participation in an interventional study.
• Patients currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the initiation of therapy with nintedanib.

Trial design

180 participants in 1 patient group

Nintedanib for patients with Idiopathic Pulmonary Fibrosis

Treatment:

Drug: Nintedanib