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The aim of this study is to identify correlations between change from the baseline at Month 24 in Forced Vital Capacity (FVC) (% predicted and mL) and change from the baseline at Month 24 in cough or dyspnoea scores [points] as measured in the living with pulmonary fibrosis questionnaire (L-PF) over 24 months of nintedanib treatment in patients with connective tissues disease-associated progressive fibrosing interstitial lung disease (CTD associated PF-ILD) under routine clinical practice conditions in Greece.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nintedanib for CTD-associated PF-ILD patients in Greece | Connective Tissue Disease (CTD)-associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug | Nintedanib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between change from baseline at Month 24 in forced vital capacity (FVC) [percentage (%) predicted] and change from baseline at Month 24 in dyspnoea symptom score [points] | 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. | At baseline and at month 24 |
| Correlation between change from baseline at Month 24 in forced vital capacity (FVC) [% predicted] and change from baseline at Month 24 in cough symptom score [points] | At baseline and at month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the change from baseline at Month 24 in forced vital capacity (FVC) [milliLitres (mL)] and change from baseline at Month 24 in dyspnoea symptom score [points] | At baseline and at month 24 | |
| Correlation between change from baseline at Month 24 in FVC [mL] and change from baseline at Month 24 in cough symptom score [points] |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with physician-diagnosed interstitial lung disease (ILD) must fulfil at least one of the following criteria for progressive fibrosing (PF)-ILD within the previous period and up to two years before the screening, despite standard treatment to treat ILD:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private physician | Athens | 10676 | Greece | |||
| Private physician |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can 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.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
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 the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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| At baseline and at month 24 |
| Correlation between baseline FVC [% pred] and change in dyspnoea symptom score [points] from baseline at month 24 | At baseline and at month 24 |
| Correlation between baseline FVC [% pred] and change in cough symptom score [points] from baseline at month 24 | At baseline and at month 24 |
| Absolute change from baseline in FVC [% pred] at month 24 | At baseline and at month 24 |
| Absolute change from baseline in FVC [mL] at month 24 | At baseline and at month 24 |
| Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) dyspnoea symptom score [points] at month 24 | At baseline and at month 24 |
| Absolute change from baseline in L-PF cough symptom score [points] at month 24 | At baseline and at month 24 |
| Change in total L-PF score [points] from baseline at month 24, or the end of the observation | At baseline and up to 24 months |
| Athens |
| 11362 |
| Greece |
| "G. Gennimatas" General Hospital of Athens | Athens | 11527 | Greece |
| "Ippokration" General Hospital of Athens | Athens | 11527 | Greece |
| "Laiko" General Hospital of Athens | Athens | 11527 | Greece |
| Private physician | Athens | 11634 | Greece |
| "ATTIKON" University General Hospital | Athens | 12462 | Greece |
| "KAT" General Hospital | Athens | 14561 | Greece |
| University General Hospital of Heraklion | Heraklion | 71003 | Greece |
| University General Hospital of Heraklion | Heraklion | 71110 | Greece |
| Private physician | Ioannina | 45332 | Greece |
| University General Hospital of Ioannina | Ioannina | 45500 | Greece |
| Private physician | Larissa | 41222 | Greece |
| University General Hospital of Larisa | Larissa | 41334 | Greece |
| Private physician | Nea Smirni, Athens | 17121 | Greece |
| Private physician | Pátrai | 26504 | Greece |
| University General Hospital of Patra | Pátrai | 26504 | Greece |
| Private physician | Thessaloniki | 54622 | Greece |
| "Hippokration" General Hospital of Thessaloniki | Thessaloniki | 54642 | Greece |
| "G. Papanikolaou" General University of Thessaloniki | Thessaloniki | 57010 | Greece |
| 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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