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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)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nintedanib treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug | Nintedanib |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic fibrosing Interstitial lung disease (ILD) with a progressive phenotype excluding Idiopathic Pulmonary Fibrosis (IPF) patients.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acibadem City Clinic Tokuda University Hospital EAD | Sofia | 1407 | Bulgaria | |||
| Medical Military Academy MHAT Sofia |
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| Label | URL |
|---|---|
| Related Info | View source |
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After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
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.
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'.
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| 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 | 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 |
| 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 |
| 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 |
| Sofia |
| 1606 |
| Bulgaria |
| University Hospital Brno | Brno | 625 00 | Czechia |
| University Hospital Brno | Brno | 62500 | Czechia |
| Nemocnice AGEL Novy Jicin a.s. | Nový Jičín | 74101 | Czechia |
| University Hospital Ostrava | Ostrava-Poruba | 708 52 | Czechia |
| Fakultni Nemocnice Plzen | Pilsen | 30100 | Czechia |
| Thomayer University Hospital | Prague | 140 59 | Czechia |
| Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy | Bydgoszcz | 85-168 | Poland |
| Mirosław Nęcki SPL | Krakow | 31-618 | Poland |
| Somed Cr Sp. z o.o. sp.k. | Lodz | 90-368 | Poland |
| IPL Michał Krawczyk | Lodz | 94-053 | Poland |
| Indywidualna SPL Małgorzata Noceń-Piskorowska | Szczecin | 70-205 | Poland |
| Biomedical Centers Sp. z o.o. | Warsaw | 00-844 | Poland |
| Prywatna Praktyka Lekarska Paweł Piesiak | Wroclaw | 50-521 | Poland |
| Hanna Jagielska Len IPL | Zielona Góra | 65-101 | Poland |
| Dr. Ion Cantacuzino Clinical Hospital | Bucharest | 020475 | Romania |
| Strambu I. Irina-Ruxandra - Activitate Medicala | Bucharest | 10991 | Romania |
| Dr. Belaconi I. Ionela-Nicoleta - Medic Specialist Pneumologie | Bucharest | 32582 | Romania |
| Dr. Toma Claudia Lucia - Medic Primar Pneumologie | Bucharest | 41651 | Romania |
| Bronz Media SRL | Cluj-Napoca | 400015 | Romania |
| Doctor 4 Sim Srl | Cluj-Napoca | 400428 | Romania |
| PFI Ramazan Ana-Maria | Constanța | 900377 | Romania |
| Sc Pneumo Clinic Dantes Srl | Constanța | 900629 | Romania |
| Pneumo Research Srl | Moşniţa Nouă | 307285 | Romania |
| Spital De Pneumologie Dr. Lavinia Davidescu S.R.L. | Oradea | 410155 | Romania |
| Dr. Fira-Mladinescu SRL | Timișoara | 300451 | Romania |
| Iasis Srl | Timișoara | 300708 | Romania |
| Universitätsspital Basel | Basel | CH - 4031 | Switzerland |
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | 1011 | Switzerland |
| HOCH Health Ostschweiz | Sankt Gallen | CH-9007 | Switzerland |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
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