N/A
N=108
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
Lung Diseases, Interstitial
Bottom Line
View on ClinicalTrials.gov: NCT04702893 ↗Enrolled (actual)
108
Serious AEs
15.7%
Results posted
Apr 2025
Primary outcome: Primary: 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 — -0.2576 Pearson's coefficient of correlation — p=0.1185
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Nintedanib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-0.2576 | 0.1185 |
| PRIMARY 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 |
-0.1093 | 0.5135 |
| SECONDARY Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [mL] and Change From Baseline to Week 52 in Dyspnea Symptom Score |
-0.2909 | 0.0764 |
| SECONDARY Correlation Between Change From Baseline to Week 52 in Forced Vital Capacity (FVC) [mL] and Change From Baseline to Week 52 in Cough Symptom Score |
-0.1566 | 0.3478 |
| SECONDARY Absolute Change From Baseline in Living With Pulmonary Fibrosis Questionnaire (L-PF) Cough Symptom Score [Points] at Week 52 |
3.86 | — |
| SECONDARY Absolute Change From Baseline in Living With Pulmonary Fibrosis Questionnaire (L-PF) Dyspnea Symptom Score [Points] at Week 52 |
6.26 | — |
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)).
Eligibility Criteria
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 30/min) in the patient's history
- Participation in a parallel interventional clinical trial
- Patients being spouse or lateral relatives to the second degree or economically dependent from the investigator
Data sourced from ClinicalTrials.gov (NCT04702893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.