Clinical trial NCT05151640: INCHANGE - Nintedanib for Changes in Cough and Dyspnea in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease 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: ACTIVE_NOT_RECRUITING
Conditions: Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-12-09
Enrollment: 160
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: Patients with chronic fibrosing Interstitial lung disease (ILD) with a progressive phenotype excluding Idiopathic Pulmonary Fibrosis (IPF) patients.

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)).


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)
* 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

Primary outcomes:
measure: 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
timeFrame: Up to week 52
measure: 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
timeFrame: Up to week 52
Secondary outcomes:
measure: 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
timeFrame: Up to week 52
measure: 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
timeFrame: Up to week 52
measure: Absolute change from baseline in living with pulmonary fibrosis (L-PF) cough symptom score [points] at week 52
timeFrame: At week 52
measure: Absolute change from baseline in living with pulmonary fibrosis (L-PF) dyspnea symptom score [points] at week 52
timeFrame: At week 52
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Acibadem CityClinic UMBAL Tokuda Hospital
city: Sofia
country: Bulgaria
facility: UMBAL Alexandrovska
city: Sofia
country: Bulgaria
facility: MBAL VMA Military Medical Academy
city: Brno
country: Czechia
facility: FN - Brno
city: Nový Jičín
country: Czechia
facility: Nemocnice AGEL Nový Jičín, a.s.
city: Ostrava - Poruba
country: Czechia
facility: Fakultní nemocnice Ostrava
city: Plzeň-Bory
country: Czechia
facility: Fakultní nemocnice Plzeň
city: Prague 4
country: Czechia
facility: Thomayer University Hospital
city: Bydgoszcz
country: Poland
facility: Jan Biziel University Hospital No. 2
city: Kraków
country: Poland
facility: Mirosław Nęcki Specjalistyczna Praktyka Lekarska
city: Szczecin
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Małgorzata Noceń-Piskorowska
city: Warsaw
country: Poland
facility: National Institute of Geriatrics, Rheumatology and Rehabilitation named after prof. dr hab. med. Eleonora Reicher
city: Warschau
country: Poland
facility: BioMedical Centers Sp. z o.o.
city: Wrocław
country: Poland
facility: Prywatna Praktyka Lekarska Paweł Piesiak
city: Zielona Góra
country: Poland
facility: Indywidualna praktyka lekarska Hanna Jagielska-Len
city: Łódź
country: Poland
facility: SOMED CR Spółka z ograniczoną odpowiedzialnością Sp. k.
city: Łódź
country: Poland
facility: Michał Krawczyk Indywidualna Praktyka Lekarska
city: Bucharest
country: Romania
facility: Strambu I. Irina-Ruxandra - Activitate Medicala
city: Bucharest
country: Romania
facility: Dr. Belaconi I. Ionela-Nicoleta - Medic Specialist Pneumologie
city: Bucharest
country: Romania
facility: Dr. Toma Claudia Lucia - Medic Primar Pneumologie
city: Bucuresti
country: Romania
facility: Dinamic Soft Srl
city: Cluj Napoca
country: Romania
facility: Bronz Media SRL
city: Cluj Napoca
country: Romania
facility: Doctor 4 Sim Srl
city: Constanta
country: Romania
facility: PFI Ramazan M. Ana-Maria Mihaela Ramazan
city: Constanta
country: Romania
facility: Sc Pneumo Clinic Dantes Srl
city: Iași
country: Romania
facility: Netconsult SRL
city: Mosnita Noua
country: Romania
facility: Pneumo Research Srl
city: Oradea
country: Romania
facility: Lavinia Davidescu Medic Primar Pneumolog SRL
city: Timisoara
country: Romania
facility: Dr. Fira-Mladinescu SRL
city: Timisoara
country: Romania
facility: Iasis Srl
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Lausanne
country: Switzerland
facility: CHUV-Centre hospitalier universitaire vaudois
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
References: