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
- Registration Number
- NCT05151640
- Lead Sponsor
- Boehringer Ingelheim
- 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)).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Nintedanib treatment group Nintedanib -
- Primary Outcome Measures
Name Time Method 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.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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (33)
Acibadem CityClinic UMBAL Tokuda Hospital
🇧🇬Sofia, Bulgaria
UMBAL Alexandrovska
🇧🇬Sofia, Bulgaria
MBAL VMA Military Medical Academy
🇧🇬Sofia, Bulgaria
Thomayer University Hospital
🇨🇿Prague 4, Czechia
Fakultní nemocnice Plzeň
🇨🇿Plzeň-Bory, Czechia
Mirosław Nęcki Specjalistyczna Praktyka Lekarska
🇵🇱Kraków, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Małgorzata Noceń-Piskorowska
🇵🇱Szczecin, Poland
BioMedical Centers Sp. z o.o.
🇵🇱Warschau, Poland
National Institute of Geriatrics, Rheumatology and Rehabilitation named after prof. dr hab. med. Eleonora Reicher
🇵🇱Warsaw, Poland
Indywidualna praktyka lekarska Hanna Jagielska-Len
🇵🇱Zielona Góra, Poland
Prywatna Praktyka Lekarska Paweł Piesiak
🇵🇱Wrocław, Poland
Michał Krawczyk Indywidualna Praktyka Lekarska
🇵🇱Łódź, Poland
Dinamic Soft Srl
🇷🇴Bucuresti, Romania
Doctor 4 Sim Srl
🇷🇴Cluj Napoca, Romania
PFI Ramazan M. Ana-Maria Mihaela Ramazan
🇷🇴Constanta, Romania
Netconsult SRL
🇷🇴Iași, Romania
Pneumo Research Srl
🇷🇴Mosnita Noua, Romania
Lavinia Davidescu Medic Primar Pneumolog SRL
🇷🇴Oradea, Romania
Iasis Srl
🇷🇴Timisoara, Romania
Universitätsspital Basel
🇨🇭Basel, Switzerland
Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
Nemocnice AGEL Nový Jičín, a.s.
🇨🇿Nový Jičín, Czechia
FN - Brno
🇨🇿Brno, Czechia
Fakultní nemocnice Ostrava
🇨🇿Ostrava - Poruba, Czechia
Jan Biziel University Hospital No. 2
🇵🇱Bydgoszcz, Poland
SOMED CR Spółka z ograniczoną odpowiedzialnością Sp. k.
🇵🇱Łódź, Poland
Dr. Belaconi I. Ionela-Nicoleta - Medic Specialist Pneumologie
🇷🇴Bucharest, Romania
Dr. Toma Claudia Lucia - Medic Primar Pneumologie
🇷🇴Bucharest, Romania
Sc Pneumo Clinic Dantes Srl
🇷🇴Constanta, Romania
Bronz Media SRL
🇷🇴Cluj Napoca, Romania
CHUV-Centre hospitalier universitaire vaudois
🇨🇭Lausanne, Switzerland
Strambu I. Irina-Ruxandra - Activitate Medicala
🇷🇴Bucharest, Romania
Dr. Fira-Mladinescu SRL
🇷🇴Timisoara, Romania