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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)

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ClinicalTrials.gov Identifier: NCT04702893
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : July 27, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The primary objective of this observational study is to investigate the correlation between changes from baseline at 52 weeks in forced vital capacity (FVC) and changes from baseline at 52 weeks in dyspnea score points or cough score points as measured with the pulmonary fibrosis questionnaire (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)).

Condition or disease Intervention/treatment
Lung Diseases, Interstitial Drug: Nintedanib

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 28, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023


Group/Cohort Intervention/treatment
Chronic fibrosing interstitial lung disease (ILD) patients with a progressive phenotype Drug: Nintedanib
Nintedanib
Other Name: Ofev®




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04702893


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Andrea Marseille, +4961327714188 andrea.marseille@boehringer-ingelheim.com
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04702893    
Other Study ID Numbers: 1199-0449
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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'.
URL: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Diseases
Dyspnea
Lung Diseases, Interstitial
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Nintedanib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action