Study identification

PURI

https://redirect.ema.europa.eu/resource/46027

EU PAS number

EUPAS38272

Study ID

46027

Official title and acronym

Prospective observational investigation of possible correlations between change in FVC and change in cough or dyspnea scores using the living with pulmonary fibrosis questionnaire (L-PF) between baseline and after approximately 52 weeks of nintedanib treatment in patients suffering from chronic fibrosing ILD with a progressive phenotype. (INREAL)

DARWIN EU® study

No

Study countries

Germany

Study description

This NIS will investigate changes in dyspnea or cough as measured with the L-PF questionnaire over 52 weeks of nintedanib treatment in patients suffering from chronic fibrosing ILD with a progressive phenotype (excluding IPF), including a snapshot-analysis before last patient in (LPI) to evaluate a possible correlation between changes in FVC and L-PF (dyspnea and cough). The study hypothezises that in a one year observational study a correlation can be found between changes in lung function measured by FVC and the changes in the scores for dyspnea and cough of the L-PF questionnaire in ILD patients. 100 patients will be included in 20 sites in Germany.

Study status

Finalised
Research institutions and networks

Institutions

Prof. Kreuter

Contact details

Michael Kreuter

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 final study report

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

More details on funding

Boehringer Ingelheim Pharma GmbH & Co. KG
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable