- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04702893
INREAL - Nintedanib for Changes in Dyspnea and Cough in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease (ILD) With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation (INREAL)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Aachen, Germany, 52071
- Universitätsklinikum Aachen, AöR
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Bad Homburg, Germany, 61350
- Pneumologische Praxis Dr. Löh
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Bad Kreuznach, Germany, 55543
- ACURA Kliniken Rheinland-Pfalz
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Berlin, Germany, 12351
- Vivantes Klinikum Neukölln
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Braunschweig, Germany, 38126
- Klinikum Braunschweig
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Chemnitz, Germany, 09116
- Klinikum Chemnitz
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Coswig, Germany, 01649
- Fachkrankenhaus Coswig GmbH
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Erlangen, Germany, 91054
- Universitätsklinikum Erlangen
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Essen, Germany, 45239
- Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
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Frankfurt, Germany, 60389
- Praxis Dr. med. Claus Keller
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Halle, Germany, 06120
- Krankenhaus Martha-Maria Halle-Dölau
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Hamburg, Germany, 20246
- Universitätsklinikum Hamburg-Eppendorf
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Heidelberg, Germany, 69126
- Universitätsklinikum Heidelberg Thoraxklinik Heidelberg Zentrum für interstitielle und seltene Lungenerkrankungen
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Hemer, Germany, 58675
- Lungenklinik Hemer in der Trägerschaft der Deutschen Gemeinschafts-Diakonieverband GmbH
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Herne, Germany, 44649
- Rheumazentrum Herne
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Köln, Germany, 51109
- Kliniken der Stadt Köln
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Leipzig, Germany, 04103
- Universitätsklinikum Leipzig
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Lemgo, Germany, 32657
- Klinikum Lippe
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Minden, Germany, 32429
- Johannes Wesling Klinikum Minden der Mühlenkreiskliniken AöR
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Solingen, Germany, 42699
- Wissenschaftliches Institut Bethanien für Pneumologie e.V.
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Wuppertal, Germany, 42283
- Petrus-Krankenhaus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
In this NIS, data on the effect of nintedanib in chronic fibrosing ILD with progressive phenotype in about 100 patients will be collected in routine clinical practice by ca. 20 specialists, experienced in treating ILD patients, (e. g. pulmonologists and rheumatologists) throughout Germany.
Patients to be recruited within this study have to have a physician diagnosed chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype (except idiopathic pulmonary fibrosis (IPF)), for which nintedanib is an indicated treatment.
Description
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)
- Treatment with nintedanib in INREAL will be the first and only prescription of any antifibrotic treatment for each individual patient within this observational study after a physician's decision being made for this treatment option earlier
- 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 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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chronic fibrosing interstitial lung disease (ILD) patients with a progressive phenotype
|
Nintedanib
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between change from baseline to week 52 in forced vital capacity (FVC) [% predicted] and change from baseline to week 52 in dyspnea symptom score
Time Frame: baseline, week 52
|
The dyspnea symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF).
L-PF dyspnea symptom score ranges from 0 to 92; the higher the score, the greater the impairment.
|
baseline, week 52
|
Correlation between change from baseline to week 52 in FVC [% predicted] and change from baseline to week 52 in cough symptom score
Time Frame: baseline, week 52
|
The cough symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF).
L-PF cough symptom score ranges from 0 to 92; the higher the score, the greater the impairment.
|
baseline, week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between change from baseline to week 52 in FVC [milliliter (ml)] and change from baseline to week 52 in dyspnea symptom score
Time Frame: baseline, week 52
|
The dyspnea symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF).
L-PF dyspnea symptom score ranges from 0 to 92; the higher the score, the greater the impairment.
|
baseline, week 52
|
Correlation between change from baseline to week 52 in FVC [ml] and change from baseline to week 52 in cough symptom score
Time Frame: baseline, week 52
|
The cough symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF).
L-PF cough symptom score ranges from 0 to 92; the higher the score, the greater the impairment.
|
baseline, week 52
|
Absolute change from baseline in L-PF cough symptom score at week 52
Time Frame: baseline, week 52
|
The cough symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF).
L-PF cough symptom score ranges from 0 to 92; the higher the score, the greater the impairment.
|
baseline, week 52
|
Absolute change from baseline in L-PF dyspnea symptom score at week 52
Time Frame: baseline, week 52
|
The dyspnea symptom score will be calculated using the living with pulmonary fibrosis questionnaire (L-PF).
L-PF dyspnea symptom score ranges from 0 to 92; the higher the score, the greater the impairment.
|
baseline, week 52
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Andrea Marseille, +4961327714188, andrea.marseille@boehringer-ingelheim.com
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1199-0449
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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