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
NCT ID: NCT05151640
Last Updated: 2025-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
158 participants
OBSERVATIONAL
2023-02-08
2025-09-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Nintedanib treatment group
Nintedanib
Nintedanib
Interventions
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Nintedanib
Nintedanib
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Acibadem City Clinic Tokuda University Hospital EAD
Sofia, , Bulgaria
Medical Military Academy MHAT Sofia
Sofia, , Bulgaria
University Hospital Brno
Brno, , Czechia
University Hospital Brno
Brno, , Czechia
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, , Czechia
University Hospital Ostrava
Ostrava-Poruba, , Czechia
Fakultni Nemocnice Plzen
Pilsen, , Czechia
Thomayer University Hospital
Prague, , Czechia
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Bydgoszcz, , Poland
Mirosław Nęcki SPL
Krakow, , Poland
Somed Cr Sp. z o.o. sp.k.
Lodz, , Poland
IPL Michał Krawczyk
Lodz, , Poland
Indywidualna SPL Małgorzata Noceń-Piskorowska
Szczecin, , Poland
Biomedical Centers Sp. z o.o.
Warsaw, , Poland
Prywatna Praktyka Lekarska Paweł Piesiak
Wroclaw, , Poland
Hanna Jagielska Len IPL
Zielona Góra, , Poland
Dr. Ion Cantacuzino Clinical Hospital
Bucharest, , Romania
Strambu I. Irina-Ruxandra - Activitate Medicala
Bucharest, , Romania
Dr. Belaconi I. Ionela-Nicoleta - Medic Specialist Pneumologie
Bucharest, , Romania
Dr. Toma Claudia Lucia - Medic Primar Pneumologie
Bucharest, , Romania
Bronz Media SRL
Cluj-Napoca, , Romania
Doctor 4 Sim Srl
Cluj-Napoca, , Romania
PFI Ramazan Ana-Maria
Constanța, , Romania
Sc Pneumo Clinic Dantes Srl
Constanța, , Romania
Pneumo Research Srl
Moşniţa Nouă, , Romania
Spital De Pneumologie Dr. Lavinia Davidescu S.R.L.
Oradea, , Romania
Dr. Fira-Mladinescu SRL
Timișoara, , Romania
Iasis Srl
Timișoara, , Romania
Universitätsspital Basel
Basel, , Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, , Switzerland
HOCH Health Ostschweiz
Sankt Gallen, , Switzerland
Countries
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Related Links
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Related Info
Other Identifiers
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1199-0467
Identifier Type: -
Identifier Source: org_study_id
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