A prospective, observational study on the correlations between change in lung function and change in cough and dyspnoea in patients with connective tissue disease-associated progressive fibrosing INTErstitial luNg diseaSE (CTD associated PF-ILD) treated with nintedanib (INTENSE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49654
• EU PAS number:
  EUPAS49653
• Study ID:
  49654
• Official title and acronym:
  A prospective, observational study on the correlations between change in lung function and change in cough and dyspnoea in patients with connective tissue disease-associated progressive fibrosing INTErstitial luNg diseaSE (CTD associated PF-ILD) treated with nintedanib (INTENSE)
• DARWIN EU® study:
  No
• Study countries:
  Greece
• Study description:
  A non-interventional, multicentre study based on newly collected data on patients with CTD-associated PF-ILDs who are eligible for treatment with nintedanib in Greece as per routine clinical practice. The primary objective of this study is to investigate the correlation between changes from baseline at Month 24 in FVC % pred. and changes from baseline at Month 24 in dyspnoea score points and cough score points as measured with the L-PF questionnaire over 24 months of nintedanib treatment in patients with CTD suffering from chronic fibrosing ILD with a progressive phenotype (excluding IPF)
• Study status:
  Planned

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Actual: 16/05/2022

Study start date

Planned: 30/11/2022

Data analysis start date

Planned: 29/01/2027

Date of final study report

Planned: 31/05/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable