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

NCT05151640 | Completed

• 1 other identifier: 1199-0467
• Study Type: observational
• Target: 158
• Locations: 5 countries
• Sites: 31

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)).

Conditions

Lung Diseases, Interstitial

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Up to week 52

• 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

  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.

  Up to week 52

Secondary Outcomes (4)

• 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

• 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

• Absolute change from baseline in living with pulmonary fibrosis (L-PF) cough symptom score [points] at week 52

  At week 52

• Absolute change from baseline in living with pulmonary fibrosis (L-PF) dyspnea symptom score [points] at week 52

  At week 52

Study Arms (1)

Nintedanib treatment group

Drug: Nintedanib

Interventions

Nintedanib DRUG

Nintedanib

Nintedanib treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (31)

Acibadem City Clinic Tokuda University Hospital EAD

Sofia, 1407, Bulgaria

Location

Medical Military Academy MHAT Sofia

Sofia, 1606, Bulgaria

Location

University Hospital Brno

Brno, 625 00, Czechia

Location

University Hospital Brno

Brno, 62500, Czechia

Location

Nemocnice AGEL Novy Jicin a.s.

Nový Jičín, 74101, Czechia

Location

University Hospital Ostrava

Ostrava-Poruba, 708 52, Czechia

Location

Fakultni Nemocnice Plzen

Pilsen, 30100, Czechia

Location

Thomayer University Hospital

Prague, 140 59, Czechia

Location

Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy

Bydgoszcz, 85-168, Poland

Location

Mirosław Nęcki SPL

Krakow, 31-618, Poland

Location

Somed Cr Sp. z o.o. sp.k.

Lodz, 90-368, Poland

Location

IPL Michał Krawczyk

Lodz, 94-053, Poland

Location

Indywidualna SPL Małgorzata Noceń-Piskorowska

Szczecin, 70-205, Poland

Location

Biomedical Centers Sp. z o.o.

Warsaw, 00-844, Poland

Location

Prywatna Praktyka Lekarska Paweł Piesiak

Wroclaw, 50-521, Poland

Location

Hanna Jagielska Len IPL

Zielona Góra, 65-101, Poland

Location

Dr. Ion Cantacuzino Clinical Hospital

Bucharest, 020475, Romania

Location

Strambu I. Irina-Ruxandra - Activitate Medicala

Bucharest, 10991, Romania

Location

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

Bucharest, 32582, Romania

Location

Dr. Toma Claudia Lucia - Medic Primar Pneumologie

Bucharest, 41651, Romania

Location

Bronz Media SRL

Cluj-Napoca, 400015, Romania

Location

Doctor 4 Sim Srl

Cluj-Napoca, 400428, Romania

Location

PFI Ramazan Ana-Maria

Constanța, 900377, Romania

Location

Sc Pneumo Clinic Dantes Srl

Constanța, 900629, Romania

Location

Pneumo Research Srl

Moşniţa Nouă, 307285, Romania

Location

Spital De Pneumologie Dr. Lavinia Davidescu S.R.L.

Oradea, 410155, Romania

Location

Dr. Fira-Mladinescu SRL

Timișoara, 300451, Romania

Location

Iasis Srl

Timișoara, 300708, Romania

Location

Universitätsspital Basel

Basel, CH - 4031, Switzerland

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, 1011, Switzerland

Location

HOCH Health Ostschweiz

Sankt Gallen, CH-9007, Switzerland

Location

Related Links

• Related Info

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 9, 2021
• Study Start: February 8, 2023
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

Locations

CZ (6); PL (8); RO (12); BU (2); CH (3)