CompletedNot Applicable

INREAL - Nintedanib for Changes in Dyspnea and Cough in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease (ILD) With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation

Germany108 participantsStarted 2021-05-28

Plain-language summary

The primary objective of this observational study is to investigate the correlation between changes from baseline at 52 weeks in forced vital capacity (FVC) and changes from baseline at 52 weeks in dyspnea score points or cough score points as measured with the pulmonary fibrosis questionnaire (L-PF) questionnaire over 52 weeks of nintedanib treatment in patients suffering from chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype (excluding idiopathic pulmonary fibrosis (IPF)).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults ≥ 18 years at Visit 1 * Subjects must be contractually capable and mentally able to understand and follow the instructions of the study personnel * Physician's diagnosis of chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype, except idiopathic pulmonary fibrosis (IPF) * Treatment with nintedanib in INREAL will be the first and only prescription of any antifibrotic treatment for each individual patient within this observational study after a physician's decision being made for this treatment option earlier * Outpatients not currently hospitalized with a life expectancy \> 12 months per investigator's assessment * Written informed consent prior to study participation * Current forced vital capacity (FVC) measurement (taken within the last 3 months) available in the patient file * Women of childbearing potential must take appropriate precautions against getting pregnant during the intake of nintedanib Exclusion Criteria: * Patients with contraindications according to Summary of Product Characteristics (SmPC) * Prior use of any antifibrotic treatment * Lack of informed consent * Pregnant or lactating females * Any physician diagnosed exacerbation of ILD in the patient's history file, irrespective of time since event * Current diagnosis of lung cancer * Respiratory failure (pH \< 7,35 and/ or respiratory rate \> 30/min) in the patient's history * Participation in a parallel interventional clinical trial * Patients being sp…

What they're measuring

Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [% Predicted] and Change From Baseline to Week 52 in Dyspnea Symptom Score

Timeframe: At baseline and at week 52±6.

Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [% Predicted] and Change From Baseline to Week 52 in Cough Symptom Score

Timeframe: At baseline and at week 52±6.

Trial details

NCT IDNCT04702893

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-09

Results submitted2025-04-08

View on ClinicalTrials.gov More Lung Diseases, Interstitial trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [% Predicted] and Change From Baseline to Week 52 in Dyspnea Symptom Score

Timeframe: At baseline and at week 52±6.

Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [% Predicted] and Change From Baseline to Week 52 in Cough Symptom Score

Timeframe: At baseline and at week 52±6.