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

NCT06912659 | Active Not Recruiting

• 1 other identifier: 1199-0575
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction with Patient Support Program (PSP) Balance Program at baseline using the Baker Questionnaire.

  Baker Questionnaire: This questionnaire contains 18 items divided into four domains. related to general satisfaction, the care provided by the professional, the time dedicated to the consultation and the relationship with the professional. There is no cut point published. Items in both modules have a five-option numeric score that ranges from 1 "Not at all" to 5 "Extremely". Total Baker score ranges from 0 to 90, with higher numbers indicating a greater satisfaction. In this study the mean value will be include.

  at Baseline

Secondary Outcomes (9)

• 1. Change in the satisfaction with Patient Support Program (PSP) Balance Program at 6 and 12-month follow-up after inclusion in the study, using the Baker Questionnaire.

  up to 12 months

• Patient satisfaction with PSP Balance Program at baseline, 6 and 12 months after the inclusion in the study using the Likert scale.

  at baseline and up to 12 months

• Dosing pattern of nintedanib calculated as absolute number of doses taken correctly divided by all the doses prescribed in that period (6 and 12 months)

  up to 12 months

• Time from first dose to permanent discontinuation of nintedanib within 12-month follow-up.

  up to 12 months

• Absolute number of nintedanib dose interruptions.

  up to 12 months

Study Arms (1)

Patients participating in the PSP Balance Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will include patients with IPF and PPF (other than IPF) participating in the PSP Balance Program. The study duration will be from the start of the recruitment period (which will last approximately 6 months) to the last follow-up visit of the last patient (approximately 18 months of total study period). Patients will be followed-up at 6 months and at 12 months.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Evidenze Health Espana S.L.

Barcelona, 08005, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 6, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

ES (1)