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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04702893
• Collaborator: (none)
• Enrollment: 100
• Locations: 20
• Anticipated Duration (Months): 31.1
• Patients Per Site: 5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	Phase
Lung Diseases, Interstitial	Drug: Nintedanib

Study Design

• Study Type: Observational
• Anticipated 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
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Chronic fibrosing interstitial lung disease (ILD) patients with a progressive phenotype	Drug: Nintedanib; Nintedanib; Other Names: Ofev®

Outcome Measures

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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Aachen, AöR	Aachen		Germany	52071
2	Pneumologische Praxis Dr. Löh	Bad Homburg		Germany	61350
3	ACURA Kliniken Rheinland-Pfalz	Bad Kreuznach		Germany	55543
4	Vivantes Klinikum Neukölln	Berlin		Germany	12351
5	Klinikum Braunschweig	Braunschweig		Germany	38126
6	Klinikum Chemnitz	Chemnitz		Germany	09116
7	Fachkrankenhaus Coswig GmbH	Coswig		Germany	01649
8	Universitätsklinikum Erlangen	Erlangen		Germany	91054
9	Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH	Essen		Germany	45239
10	Praxis Dr. med. Claus Keller	Frankfurt		Germany	60389
11	Krankenhaus Martha-Maria Halle-Dölau	Halle		Germany	06120
12	Universitätsklinikum Hamburg-Eppendorf	Hamburg		Germany	20246
13	Universitätsklinikum Heidelberg Thoraxklinik Heidelberg Zentrum für interstitielle und seltene Lungener	Heidelberg		Germany	69126
14	Lungenklinik Hemer in der Trägerschaft der Deutschen Gemeinschafts-Diakonieverband GmbH	Hemer		Germany	58675
15	Rheumazentrum Herne	Herne		Germany	44649
16	Kliniken der Stadt Köln	Köln		Germany	51109
17	Universitätsklinikum Leipzig	Leipzig		Germany	04103
18	Klinikum Lippe	Lemgo		Germany	32657
19	Wissenschaftliches Institut Bethanien für Pneumologie e.V.	Solingen		Germany	42699
20	Petrus-Krankenhaus	Wuppertal		Germany	42283

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Andrea Marseille, [phone], [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT04702893
• Other Study ID Numbers: 1199-0449
• First Posted: Jan 11, 2021
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: Lung Diseases; Dyspnea; Lung Diseases, Interstitial; Nintedanib

Study Results

No Results Posted as of Aug 23, 2022