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

NCT04702893 | Completed Results

• 1 other identifier: 1199-0449
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 21

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

Outcome Measures

Primary Outcomes (2)

• 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

  The correlation between the change from baseline to week 52 (week 52 - baseline) in forced vital capacity (FVC) \[% predicted\] and change from baseline to week 52 (week 52 - baseline) in dyspnea symptom score was calculated using the Pearson's coefficient of correlation. The forced vital capacity measures the amount of air that can be forcefully exhaled from the lungs after a maximum inhalation. The dyspnea symptom score was measured using the living with pulmonary fibrosis questionnaire (L-PF). The L-PF contained a dyspnea symptom module with 12 items to assess the severity of shortness of breath, where the higher the score, the greater the impairment. The coefficient of correlation ranges from -1 to 1, indicating a negative association between the variables the closer it is to -1 and a positive association the closer it is to 1.

  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

  The correlation between the change from baseline to week 52 (week 52 - baseline) in forced vital capacity (FVC) \[% predicted\] and change from baseline to week 52 (week 52 - baseline) in cough symptom score was calculated using the Pearson's coefficient of correlation. The forced vital capacity measures the amount of air that can be forcefully exhaled from the lungs after a maximum inhalation. The cough symptom score was measured using the living with pulmonary fibrosis questionnaire (L-PF). The L-PF contained a cough symptom module with 6 items to assess the severity of cough symptoms, where the higher the score, the more severe the cough. The coefficient of correlation ranges from -1 to 1, indicating a negative association between the variables the closer it is to -1 and a positive association the closer it is to 1.

  At baseline and at week 52±6.

Secondary Outcomes (4)

• 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

  At baseline and at week 52±6.

• 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

  At baseline and at week 52±6.

• Absolute Change From Baseline in Living With Pulmonary Fibrosis Questionnaire (L-PF) Cough Symptom Score [Points] at Week 52

  MMRM included measurements at week 13±6, week 26±6, week 39±6 and week 52±6. Change from baseline values at week 52±6 is reported.

• Absolute Change From Baseline in Living With Pulmonary Fibrosis Questionnaire (L-PF) Dyspnea Symptom Score [Points] at Week 52

  MMRM included measurements at week 13±6, week 26±6, week 39±6 and week 52±6. Change from baseline values at week 52±6 is reported.

Study Arms (1)

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.

Drug: Nintedanib

Interventions

Nintedanib 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.

Also known as: Ofev®

Nintedanib-treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this NIS, data on the effect of nintedanib in chronic fibrosing ILD with progressive phenotype in about 100 patients will be collected in routine clinical practice by ca. 20 specialists, experienced in treating ILD patients, (e. g. pulmonologists and rheumatologists) throughout Germany. Patients to be recruited within this study have to have a physician diagnosed chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype (except idiopathic pulmonary fibrosis (IPF)), for which nintedanib is an indicated treatment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (21)

Universitätsklinikum Aachen, AöR

Aachen, 52071, Germany

Location

Pneumologische Praxis Dr. Löh

Bad Homburg, 61350, Germany

Location

ACURA Kliniken Rheinland-Pfalz

Bad Kreuznach, 55543, Germany

Location

Vivantes Klinikum Neukölln

Berlin, 12351, Germany

Location

Klinikum Braunschweig

Braunschweig, 38126, Germany

Location

Klinikum Chemnitz

Chemnitz, 09116, Germany

Location

Kliniken der Stadt Köln

Cologne, 51109, Germany

Location

Fachkrankenhaus Coswig GmbH

Coswig, 01649, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45239, Germany

Location

Praxis Dr. med. Claus Keller

Frankfurt, 60389, Germany

Location

Krankenhaus Martha-Maria Halle-Dölau

Halle, 06120, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Universitätsklinikum Heidelberg Thoraxklinik Heidelberg Zentrum für interstitielle und seltene Lungenerkrankungen

Heidelberg, 69126, Germany

Location

Lungenklinik Hemer in der Trägerschaft der Deutschen Gemeinschafts-Diakonieverband GmbH

Hemer, 58675, Germany

Location

Rheumazentrum Herne

Herne, 44649, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Klinikum Lippe

Lemgo, 32657, Germany

Location

Johannes Wesling Klinikum Minden der Mühlenkreiskliniken AöR

Minden, 32429, Germany

Location

Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Solingen, 42699, Germany

Location

Petrus-Krankenhaus

Wuppertal, 42283, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Andrea Marseille, +4961327714188

  andrea.marseille@boehringer-ingelheim.com

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: May 28, 2021
• Primary Completion: April 9, 2024
• Study Completion: April 9, 2024
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

Locations

DE (21)