Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Lung Diseases, Interstitial
Eligibility:
All Genders
18+ years
Brief 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 dy...
Eligibility Criteria
Inclusion
- 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
- 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 spouse or lateral relatives to the second degree or economically dependent from the investigator
Key Trial Info
Start Date :
May 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 9 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04702893
Start Date
May 28 2021
End Date
April 9 2024
Last Update
April 25 2025
Active Locations (21)
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1
Universitätsklinikum Aachen, AöR
Aachen, Germany, 52071
2
Pneumologische Praxis Dr. Löh
Bad Homburg, Germany, 61350
3
ACURA Kliniken Rheinland-Pfalz
Bad Kreuznach, Germany, 55543
4
Vivantes Klinikum Neukölln
Berlin, Germany, 12351