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 Clinical Trial

— INREAL  

Official title:

Prospective Observational Investigation of Possible Correlations Between Change in FVC and Change in Cough or Dyspnea Scores Using the Living With Pulmonary Fibrosis Questionnaire (L-PF) Between Baseline and After Approximately 52 Weeks of Nintedanib Treatment in Patients Suffering From Chronic Fibrosing ILD With a Progressive Phenotype

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04702893
• Other study ID #: 1199-0449
• Status: Active, not recruiting
• Start date: May 28, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Drug:
• Nintedanib
Nintedanib

Locations

Country	Name	City	State
Germany	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	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	Kliniken der Stadt Köln	Köln
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	The dyspnea symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF dyspnea symptom score ranges from 0 to 92; the higher the score, the greater the impairment.	baseline, week 52
Primary	Correlation between change from baseline to week 52 in FVC [% predicted] and change from baseline to week 52 in cough symptom score	The cough symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF cough symptom score ranges from 0 to 92; the higher the score, the greater the impairment.	baseline, week 52
Secondary	Correlation between change from baseline to week 52 in FVC [milliliter (ml)] and change from baseline to week 52 in dyspnea symptom score	The dyspnea symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF dyspnea symptom score ranges from 0 to 92; the higher the score, the greater the impairment.	baseline, week 52
Secondary	Correlation between change from baseline to week 52 in FVC [ml] and change from baseline to week 52 in cough symptom score	The cough symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF cough symptom score ranges from 0 to 92; the higher the score, the greater the impairment.	baseline, week 52
Secondary	Absolute change from baseline in L-PF cough symptom score at week 52	The cough symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF cough symptom score ranges from 0 to 92; the higher the score, the greater the impairment.	baseline, week 52
Secondary	Absolute change from baseline in L-PF dyspnea symptom score at week 52	The dyspnea symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF). L-PF dyspnea symptom score ranges from 0 to 92; the higher the score, the greater the impairment.	baseline, week 52

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