Lung Diseases, Interstitial
Conditions
Brief summary
The primary objective of this study is to investigate the correlation between changes from baseline to 52 weeks in Forced Vital Capacity (FVC) \[% pred.\] and changes from baseline to 52 weeks in dyspnea score \[points\] or cough score \[points\] as measured with the living with pulmonary fibrosis (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)).
Interventions
DRUGNintedanib
Nintedanib
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) * Initiation of nintedanib as first antifibrotic therapy according to physician´s decision which has been made as part of routine care prior to and independent of study inclusion * 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 Interstitial lung disease (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between change from baseline to week 52 in Forced vital capacity (FVC) [% pred.] and change from baseline to week 52 in dyspnea symptom score | Up to week 52 | The living with pulmonary fibrosis (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of health related quality of life (HRQoL) over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. •Items in both modules have response options on a five-option numeric rating score with an anchor of 0 Not at all to 4 Extremely. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. |
| Correlation between change from baseline to week 52 in Forced vital capacity (FVC) [% pred.] and change from baseline to week 52 in cough symptom score | Up to week 52 | The living with pulmonary fibrosis (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of HRQoL over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. •Items in both modules have response options on a five-option numeric rating score with an anchor of 0 Not at all to 4 Extremely. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between change from baseline to week 52 in Forced vital capacity (FVC) [millilitres mL] and change from baseline to week 52 in dyspnea symptom score | Up to week 52 | The living with pulmonary fibrosis (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of HRQoL over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. •Items in both modules have response options on a five-option numeric rating score with an anchor of 0 Not at all to 4 Extremely. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. |
| Correlation between change from baseline to week 52 in Forced vital capacity (FVC) [millilitres mL] and change from baseline to week 52 in cough symptom score | Up to week 52 | The living with pulmonary fibrosis (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of HRQoL over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. •Items in both modules have response options on a five-option numeric rating score with an anchor of 0 Not at all to 4 Extremely. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. |
| Absolute change from baseline in living with pulmonary fibrosis (L-PF) cough symptom score [points] at week 52 | At week 52 | The living with pulmonary fibrosis (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of HRQoL over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. •Items in both modules have response options on a five-option numeric rating score with an anchor of 0 Not at all to 4 Extremely. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. |
| Absolute change from baseline in living with pulmonary fibrosis (L-PF) dyspnea symptom score [points] at week 52 | At week 52 | The living with pulmonary fibrosis (L-PF) questionnaire for dyspnea/cough symptom score consists of 44 items divided into two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module assesses shortness of breath (dyspnea), cough and fatigue over the last 24 hours. The Impacts module assesses multiple aspects of HRQoL over the last 7 days. Symptoms and Impacts scores are used to calculate a total score. •Items in both modules have response options on a five-option numeric rating score with an anchor of 0 Not at all to 4 Extremely. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. |
Countries
Bulgaria, Czechia, Poland, Romania, Switzerland
Outcome results
None listed