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

Lung Diseases, Interstitial Clinical Trial

Official title:

Prospective Observational Investigation of Possible Correlations Between Change in FVC and Change in Cough or Dyspnea Scores Using the Living With Pulmonary Fibrosis Questionnaire (L-PF) Between Baseline and After Approximately 52 Weeks of Nintedanib Treatment in Patients Suffering From Chronic Fibrosing ILD With a Progressive Phenotype

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05151640
• Other study ID #: 1199-0467
• Status: Recruiting
• Start date: September 26, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Drug:
• Nintedanib
Nintedanib

Locations

Country	Name	City	State
Bulgaria	Acibadem CityClinic UMBAL Tokuda Hospital	Sofia
Bulgaria	MBAL VMA Military Medical Academy	Sofia
Bulgaria	UMBAL Alexandrovska	Sofia
Czechia	FN - Brno	Brno
Czechia	Nemocnice AGEL Nový Jicín, a.s.	Nový Jicín
Czechia	Fakultní nemocnice Ostrava	Ostrava - Poruba
Czechia	Fakultní nemocnice Plzen	Plzen-Bory
Czechia	Thomayer University Hospital	Prague 4
Poland	Jan Biziel University Hospital No. 2	Bydgoszcz
Poland	SOMED CR Spólka z ograniczona odpowiedzialnoscia Sp. k.	Lódz
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Malgorzata Nocen-Piskorowska	Szczecin
Poland	BioMedical Centers Sp. z o.o.	Warschau
Poland	Prywatna Praktyka Lekarska Pawel Piesiak	Wroclaw
Romania	Dr. Belaconi I. Ionela-Nicoleta - Medic Specialist Pneumologie	Bucharest
Romania	Dr. Toma Claudia Lucia - Medic Primar Pneumologie	Bucharest
Romania	Strambu I. Irina-Ruxandra - Activitate Medicala	Bucharest
Romania	Dinamic Soft Srl	Bucuresti
Romania	Bronz Media SRL	Cluj Napoca
Romania	Doctor 4 Sim Srl	Cluj Napoca
Romania	PFI Ramazan M. Ana-Maria Mihaela Ramazan	Constanta
Romania	Sc Pneumo Clinic Dantes Srl	Constanta
Romania	Netconsult SRL	Ia?i
Romania	Pneumo Research Srl	Mosnita Noua
Romania	Lavinia Davidescu Medic Primar Pneumolog SRL	Oradea
Romania	Dr. Fira-Mladinescu SRL	Timisoara
Romania	Iasis Srl	Timisoara
Switzerland	Universitätsspital Basel	Basel
Switzerland	CHUV-Centre hospitalier universitaire vaudois	Lausanne
Switzerland	Kantonsspital St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Bulgaria,  Czechia,  Poland,  Romania,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	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	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	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	Absolute change from baseline in living with pulmonary fibrosis (L-PF) cough symptom score [points] 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.	At week 52
Secondary	Absolute change from baseline in living with pulmonary fibrosis (L-PF) dyspnea symptom score [points] 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.	At week 52

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