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

Last updated: April 15, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Nintedanib

Clinical Study ID

NCT05151640
1199-0467
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Adults ≥ 18 years at Visit 1

  • Subjects must be contractually capable and mentally able to understand and followthe instructions of the study personnel

  • Physician's diagnosis of chronic fibrosing Interstitial lung disease (ILD) with aprogressive phenotype, except Idiopathic pulmonary fibrosis (IPF)

  • Initiation of nintedanib as first antifibrotic therapy according to physician´sdecision which has been made as part of routine care prior to and independent ofstudy inclusion

  • Outpatients not currently hospitalized with a life expectancy > 12 months perinvestigator'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 gettingpregnant during the intake of nintedanib.

Exclusion

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 thepatient'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'shistory

  • Participation in a parallel interventional clinical trial

  • Patients being spouse or lateral relatives to the second degree or economicallydependent from the investigator

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Nintedanib
Phase:
Study Start date:
February 08, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Acibadem CityClinic UMBAL Tokuda Hospital

    Sofia, 1407
    Bulgaria

    Site Not Available

  • MBAL VMA Military Medical Academy

    Sofia, 1606
    Bulgaria

    Site Not Available

  • UMBAL Alexandrovska

    Sofia, 1431
    Bulgaria

    Site Not Available

  • FN - Brno

    Brno, 62500
    Czechia

    Site Not Available

  • Nemocnice AGEL Nový Jičín, a.s.

    Nový Jičín, 74101
    Czechia

    Site Not Available

  • Fakultní nemocnice Ostrava

    Ostrava - Poruba, 708 52
    Czechia

    Site Not Available

  • Fakultní nemocnice Plzeň

    Plzeň-Bory, 30100
    Czechia

    Site Not Available

  • Thomayer University Hospital

    Prague 4, 140 59
    Czechia

    Site Not Available

  • Jan Biziel University Hospital No. 2

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Mirosław Nęcki Specjalistyczna Praktyka Lekarska

    Kraków, 31618
    Poland

    Site Not Available

  • Indywidualna Specjalistyczna Praktyka Lekarska Małgorzata Noceń-Piskorowska

    Szczecin, 70-205
    Poland

    Site Not Available

  • National Institute of Geriatrics, Rheumatology and Rehabilitation named after prof. dr hab. med. Eleonora Reicher

    Warsaw, 02-637
    Poland

    Site Not Available

  • SOMED CR Spółka z ograniczoną odpowiedzialnością Sp. k.

    Warsaw, 01-551
    Poland

    Site Not Available

  • BioMedical Centers Sp. z o.o.

    Warschau, 00-844
    Poland

    Site Not Available

  • Prywatna Praktyka Lekarska Paweł Piesiak

    Wrocław, 50-521
    Poland

    Site Not Available

  • Indywidualna praktyka lekarska Hanna Jagielska-Len

    Zielona Góra, 65-101
    Poland

    Site Not Available

  • Michał Krawczyk Indywidualna Praktyka Lekarska

    Łódź, 94-053
    Poland

    Site Not Available

  • SOMED CR Spółka z ograniczoną odpowiedzialnością Sp. k.

    Łódź, 90-368
    Poland

    Site Not Available

  • Dr. Belaconi I. Ionela-Nicoleta - Medic Specialist Pneumologie

    Bucharest, 32582
    Romania

    Site Not Available

  • Dr. Toma Claudia Lucia - Medic Primar Pneumologie

    Bucharest, 41651
    Romania

    Site Not Available

  • Strambu I. Irina-Ruxandra - Activitate Medicala

    Bucharest, 10991
    Romania

    Site Not Available

  • Dinamic Soft Srl

    Bucuresti, 21172
    Romania

    Site Not Available

  • Bronz Media SRL

    Cluj Napoca, 400015
    Romania

    Site Not Available

  • Doctor 4 Sim Srl

    Cluj Napoca, 400428
    Romania

    Site Not Available

  • PFI Ramazan M. Ana-Maria Mihaela Ramazan

    Constanta, 900377
    Romania

    Site Not Available

  • Sc Pneumo Clinic Dantes Srl

    Constanta, 900629
    Romania

    Site Not Available

  • Netconsult SRL

    Iași, 700141
    Romania

    Site Not Available

  • Pneumo Research Srl

    Mosnita Noua, 307285
    Romania

    Site Not Available

  • Sc Pneumologie Dr Traila Srl

    Mosnita Noua, 307285
    Romania

    Active - Recruiting

  • Lavinia Davidescu Medic Primar Pneumolog SRL

    Oradea, 410155
    Romania

    Site Not Available

  • Dr. Fira-Mladinescu SRL

    Timisoara, 300451
    Romania

    Site Not Available

  • Iasis Srl

    Timisoara, 300708
    Romania

    Site Not Available

  • Universitätsspital Basel

    Basel, CH - 4031
    Switzerland

    Site Not Available

  • CHUV-Centre hospitalier universitaire vaudois

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Kantonsspital St. Gallen

    St. Gallen, CH-9007
    Switzerland

    Site Not Available

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