Clinical trial NCT04702893: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)).


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

Primary outcomes:
measure: 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
timeFrame: At baseline and at week 52±6.
measure: 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
timeFrame: At baseline and at week 52±6.
Secondary outcomes:
measure: 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
timeFrame: At baseline and at week 52±6.
measure: 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
timeFrame: At baseline and at week 52±6.
measure: Absolute Change From Baseline in Living With Pulmonary Fibrosis Questionnaire (L-PF) Cough Symptom Score [Points] at Week 52
timeFrame: 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.
measure: Absolute Change From Baseline in Living With Pulmonary Fibrosis Questionnaire (L-PF) Dyspnea Symptom Score [Points] at Week 52
timeFrame: 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.
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, AöR
city: Bad Homburg
country: Germany
facility: Pneumologische Praxis Dr. Löh
city: Bad Kreuznach
country: Germany
facility: ACURA Kliniken Rheinland-Pfalz
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Braunschweig
country: Germany
facility: Klinikum Braunschweig
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig GmbH
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
city: Frankfurt
country: Germany
facility: Praxis Dr. med. Claus Keller
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg Thoraxklinik Heidelberg Zentrum für interstitielle und seltene Lungenerkrankungen
city: Hemer
country: Germany
facility: Lungenklinik Hemer in der Trägerschaft der Deutschen Gemeinschafts-Diakonieverband GmbH
city: Herne
country: Germany
facility: Rheumazentrum Herne
city: Köln
country: Germany
facility: Kliniken der Stadt Köln
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Lemgo
country: Germany
facility: Klinikum Lippe
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden der Mühlenkreiskliniken AöR
city: Solingen
country: Germany
facility: Wissenschaftliches Institut Bethanien für Pneumologie e.V.
city: Wuppertal
country: Germany
facility: Petrus-Krankenhaus
Study officials:
affiliation: andrea.marseille@boehringer-ingelheim.com
name: Andrea Marseille, +4961327714188
role: STUDY_CHAIR
References: