Study identification

EU PAS number

EUPAS1000000550

Study ID

1000000550

Official title and acronym

Non-interventional prospective study in patients with pulmonary fibrosis treated with nintedanib participating in a patient support program in Spain, to describe patient satisfaction with the program and to monitor quality of life. BALANCE Study

DARWIN EU® study

No

Study countries

Spain

Study description

Interstitial Lung Disease (ILD) are a heterogeneous group of diseases characterized by excessive deposition of extracellular matrix components within the pulmonary interstitium, leading to architectural distortion, irreversible pulmonary dysfunction, and early mortality.
Idiopathic pulmonary fibrosis (IPF) is the archetypal and most frequent fibrotic ILDs (accounts for 20% of them). In recent years, the term progressive pulmonary fibrosis (PPF) -also referred as progressive fibrosis ILD- has emerged. It refers to patients with ILDs -other than IPF- who develop pulmonary fibrosis of known or unknown cause, who present worsening respiratory symptoms, and physiological/ radiological evidence of progression.
Nintedanib reduces disease progression in IPF and PPF slows the decline in lung function.
However, diarrhea is reported by 66.9% to 75.7% of nintedanib-treated and it is the main cause of discontinuation.
Patient support program (PSP) has been developed to help patients better manage their disease and adherence to treatments and it could be very helpful for these patients.
Despite that, there is no evidence regarding patients’ satisfaction and quality of life.
The aim of this study is to describe patients’ satisfaction with PSP Balance Program, QoL 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.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Beatriz Román

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable