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

NCT ID: NCT06912659

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

157 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-23

Study Completion Date

2026-12-23

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients participating in the PSP Balance Program

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Evidenze Health Espana S.L.

Barcelona, , Spain

Site Status

Countries

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Spain

Related Links

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Other Identifiers

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1199-0575

Identifier Type: -

Identifier Source: org_study_id

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