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Trial record 72 of 317 for:    "Pulmonary Fibrosis, Idiopathic"

Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain

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ClinicalTrials.gov Identifier: NCT03281200
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The present study has been designed to characterize IPF patients treated with nintedanib (OFEV®), at time of treatment initiation, with respect to their clinical profile based on real-world data from January 2016 in Spanish Pulmonology Services.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Drug: L - Antineoplastic and immunomodulating agents Drug: L01 - Antineoplastic agents Drug: L01X - Other antineoplastic agents Drug: L01XE - Protein kinase inhibitors Drug: L01XE31 - Nintedanib

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Study Type : Observational
Actual Enrollment : 173 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Multicentre, Retrospective Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain.
Actual Study Start Date : October 24, 2017
Actual Primary Completion Date : June 7, 2018
Actual Study Completion Date : June 7, 2018


Group/Cohort Intervention/treatment
Anatomical main group: Drug: L - Antineoplastic and immunomodulating agents
L - Antineoplastic and immunomodulating agents

Therapeutic subgroup Drug: L01 - Antineoplastic agents
L01 - Antineoplastic agents

Pharmacological subgroup Drug: L01X - Other antineoplastic agents
L01X - Other antineoplastic agents

Chemical subgroup Drug: L01XE - Protein kinase inhibitors
L01XE - Protein kinase inhibitors

Chemical substance Drug: L01XE31 - Nintedanib
L01XE31 - Nintedanib
Other Name: OVEF




Primary Outcome Measures :
  1. distribution of patients across different lung function categories (%FVC and DLCO serving as surrogate markers for IPF severity) of IPF patients at the time of treatment initiation with nintedanib (OFEV®) in routine clinical practice [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. frequency of each method of diagnosis [ Time Frame: 1 day ]
  2. mean duration of the disease from diagnosis to treatment initiation [ Time Frame: 1 day ]
  3. frequency of patients with associated emphysema [ Time Frame: 1 day ]
  4. frequency of patients with UIP pattern (according to international guideline, Raghu et al. 2011) [ Time Frame: 1 day ]
  5. OFEV® treatment initiation date of each dose [ Time Frame: 1 day ]
  6. OFEV® treatment initiation frequency of each dose [ Time Frame: 1 day ]
  7. Patient demographics (age, male and female, race) [ Time Frame: 1 day ]
  8. Physical examination ( height, weight, BMI, mean distance of the 6 minutes walking [ Time Frame: 1 day ]
  9. smoking status (current smokers, former smokers and never smokers) [ Time Frame: 1 day ]
  10. breathlessness grade mMRC [ Time Frame: 1 day ]
  11. concomitant medication (active substance, dose, initiation date, indication) [ Time Frame: 1 day ]
  12. Mean Number of exacerbations due to IPF in the previous year [ Time Frame: 1 day ]
  13. Mean frequency of exacerbations due to IPF in the previous year [ Time Frame: 1 day ]


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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
Approximately 175 IPF patients from 35 Pulmonology Services in Spain are planned to be included in the study.
Criteria

Inclusion Criteria:

  • The patient is at least 18 years old
  • The patient has IPF diagnosis according to most recent ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management [5]
  • The patient newly initiated treatment with nintedanib (OFEV®) since 01 January 2016 up to end of data collection date, according to the approved local SmPC. -

Exclusion Criteria:

- Patients treated with nintedanib within a clinical trial or named-patient program or with any prior treatment of nintedanib.


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): NCT03281200


Locations
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Spain
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Barcelona, Spain, 08029
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03281200     History of Changes
Other Study ID Numbers: 1199-0295
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Idiopathic Pulmonary Fibrosis
Fibrosis
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Nintedanib
Antineoplastic Agents
Protein Kinase Inhibitors
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs