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

NCT ID: NCT04702893

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-28
• Study Completion Date: 2024-04-09

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 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)).

Conditions

Lung Diseases, Interstitial

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Nintedanib-treated patients

Patients diagnosed with chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype (excluding idiopathic pulmonary fibrosis (IPF)), who did not receive previous antifibrotic treatment, received 150 milligrams (mg) of nintedanib twice daily, administered 12 hours apart, according to the approved label, for approximately 52 weeks. Participants who did not tolerate 150 mg of nintedanib switched to 100 mg twice daily.

Nintedanib

Intervention Type: DRUG

150 or 100 milligrams (mg) of nintedanib, when 150 mg is not tolerated, twice daily, administered 12 hours apart, according to the approved label.

Interventions

Nintedanib

150 or 100 milligrams (mg) of nintedanib, when 150 mg is not tolerated, twice daily, administered 12 hours apart, according to the approved label.

Intervention Type: DRUG

Other Intervention Names

Ofev®

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 < 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Marseille, +4961327714188

Role: STUDY_CHAIR

andrea.marseille@boehringer-ingelheim.com

Locations

Universitätsklinikum Aachen, AöR

Aachen, , Germany

Pneumologische Praxis Dr. Löh

Bad Homburg, , Germany

ACURA Kliniken Rheinland-Pfalz

Bad Kreuznach, , Germany

Vivantes Klinikum Neukölln

Berlin, , Germany

Klinikum Braunschweig

Braunschweig, , Germany

Klinikum Chemnitz

Chemnitz, , Germany

Kliniken der Stadt Köln

Cologne, , Germany

Fachkrankenhaus Coswig GmbH

Coswig, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, , Germany

Praxis Dr. med. Claus Keller

Frankfurt, , Germany

Krankenhaus Martha-Maria Halle-Dölau

Halle, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Universitätsklinikum Heidelberg Thoraxklinik Heidelberg Zentrum für interstitielle und seltene Lungenerkrankungen

Heidelberg, , Germany

Lungenklinik Hemer in der Trägerschaft der Deutschen Gemeinschafts-Diakonieverband GmbH

Hemer, , Germany

Rheumazentrum Herne

Herne, , Germany

Universitätsklinikum Leipzig

Leipzig, , Germany

Klinikum Lippe

Lemgo, , Germany

Johannes Wesling Klinikum Minden der Mühlenkreiskliniken AöR

Minden, , Germany

Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Solingen, , Germany

Petrus-Krankenhaus

Wuppertal, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

1199-0449

Identifier Type: -

Identifier Source: org_study_id