The BALANCE Study: A Study in Spain to Find Out Whether a Patient Support Program Helps People With Pulmonary Fibrosis Who Take Nintedanib

Boehringer Ingelheim

Status: Active, not recruiting

Conditions: Pulmonary Fibrosis

Study type: Observational

Funder types: Industry

Identifiers

NCT06912659

1199-0575

Details and patient eligibility

About

The aim of this study is to describe patients' satisfaction with Patient Support Program (Balance Program), Quality of Life and depression symptoms, dosing pattern, disease symptoms, adverse events and nintedanib discontinuation (both permanent and non-permanent) from study inclusion to 12 months of follow-up.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Adults (≥18 years old at baseline).
• Patients included in the Patient Support Program (PSP) Balance Program.
• Ability to read and speak Spanish correctly according to the investigator criteria.
• Agree to participate and signing informed consent at baseline.

Exclusion criteria

- Suspicion or diagnosis of any relevant cognitive impairment at the discretion of the investigator.

Trial design

157 participants in 1 patient group

Patients participating in the PSP Balance Program