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 range

18 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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.