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

Active, not recruiting

• Conditions: Lung Diseases, Interstitial
• Interventions: Drug: Nintedanib

• 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

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-09
• Study Start: 2023-02-08
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2025-08-11
• Study Completion: 2025-08-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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

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

FN - Brno; 🇨🇿 Brno, Czechia

Nemocnice AGEL Nový Jičín, a.s.; 🇨🇿 Nový Jičín, Czechia

Fakultní nemocnice Ostrava; 🇨🇿 Ostrava - Poruba, Czechia

Fakultní nemocnice Plzeň; 🇨🇿 Plzeň-Bory, Czechia

Thomayer University Hospital; 🇨🇿 Prague 4, Czechia

Jan Biziel University Hospital No. 2; 🇵🇱 Bydgoszcz, Poland

Mirosław Nęcki Specjalistyczna Praktyka Lekarska; 🇵🇱 Kraków, Poland

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