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

Boehringer Ingelheim108 enrolled

Overview

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)).

Study Type

OBSERVATIONAL

Enrollment

108

Conditions

Lung Diseases, Interstitial

Interventions

NintedanibDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

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

...and 11 more locations

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: At baseline and at week 52±6.

Secondary Outcomes

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

The correlation between the change from baseline to week 52 (week 52 - baseline) in forced vital capacity (FVC) \[mL\] 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.

Time frame: 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

The correlation between the change from baseline to week 52 (week 52 - baseline) in forced vital capacity (FVC) \[mL\] 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.

Time frame: 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

This outcome measured the absolute change from baseline to week 52 in the cough symptom score, assessed by the living with pulmonary fibrosis questionnaire (L-PF). The L-PF includes a cough symptom module with 6 items to evaluate the severity of cough symptoms. Each item is scored on a scale of 0 to 4, with higher scores indicating more severe symptoms. The total cough symptom score was calculated using the formula: (sum of each individual score/24)\*100, ranging from 0 to 100, where the higher the score, the more severe the cough. Results were calculated as \[Week 52\] - \[Baseline\]. The analysis was performed using a mixed model for repeated measures (MMRM) with fixed independent effects for baseline value, visit, and baseline-by-visit interaction, and a random effect for each patient. Within-patient errors were represented using an unstructured variance-covariance structure.

Time frame: 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

This outcome measured the absolute change from baseline to week 52 in the dyspnea symptom score, assessed by the living with pulmonary fibrosis questionnaire (L-PF). The L-PF includes a dyspnea symptom module with 12 items to evaluate the severity of dyspnea symptoms. Each item is scored on a scale of 0 to 5, with higher scores indicating more severe symptoms. The total dyspnea symptom score was calculated using the formula: (sum of each individual score/total score possible)\*100, ranging from 0 to 100, where the higher the score, the more severe the dyspnea. Results were calculated as \[Week 52\] - \[Baseline\]. The analysis was performed using a mixed model for repeated measures (MMRM) with fixed independent effects for baseline value, visit, and baseline-by-visit interaction, and a random effect for each patient. Within-patient errors were represented using an unstructured variance-covariance structure.

Time frame: 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.