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Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib (QUALIFY IPF)

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ClinicalTrials.gov Identifier: NCT03710824
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Multi-center, non-interventional, prospective cohort study aiming to enroll 120 Idiopathic Pulmonary Fibrosis patients receiving treatment with nintedanib in a consecutive manner from 10-12 reference centers across Greece.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Drug: Nintedanib

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : March 26, 2021
Estimated Study Completion Date : March 26, 2021


Group/Cohort Intervention/treatment
Subjects with Idiopathic Pulmonary Fibrosis Drug: Nintedanib
diagnosed IPF patients initiating treatment with nintedanib




Primary Outcome Measures :
  1. Mean change from baseline in Health Related Quality of Life (HRQoL) using SGRQ score [ Time Frame: upto 52 weeks ]
    St. George's Respiratory Questionnaire (SGRQ)


Secondary Outcome Measures :
  1. measurement of mean change from baseline of dyspnoea burden with modified Medical Research Council scale (mMRC) questinnaire time-point [ Time Frame: upto 12 months ]
    modified Medical Research Council scale (mMRC)

  2. measurement of mean change form baseline to the follow up period of cough burden with Cough-Visual Analogue scale (cough-VAS) time-point [ Time Frame: upto 12 months ]
    Cough-Visual Analogue scale (cough-VAS)

  3. Percentage of adhered patients to nintedanib treatment with Simplified Medication Adherence Questionnaire (SMAQ) [ Time Frame: upto 52 weeks ]
    adapted for the treatment of idiopathic pulmonary fibrosis (IPF)

  4. measurement of mean change of anxiety in IPF patients treated with nintedanib from baseline to follow up period period via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire [ Time Frame: upto 52 weeks ]
    Generalized Anxiety Disorder Screener (GAD-7) Questionnaire

  5. Percentage of patients that use LTOT [ Time Frame: upto 52 weeks ]
    Long Term Oxygen Treatment (LTOT)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed IPF patients initiating treatment with nintedanib according to their physician's clinical decision will be enrolled in this study. In details, patients will be eligible to enroll in the study if the fulfil all the inclusion criteria.
Criteria

Inclusion Criteria:

  • Patients ≥40 years of age.
  • Patients that have signed Informed Consent Form.
  • Treatment naive patients with an initial IPF diagnosis no more than 3 months prior to enrolment according to 2011 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines who are initiating treatment with nintedanib (as monotherapy for IPF) or have initiated treatment with nintedanib (as monotherapy for IPF) within the past 7 days prior to enrolment.
  • Patients for whom the decision to prescribe therapy with nintedanib according to the locally approved product's Summary of Product Characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study.
  • Patients that are able to read, understand and complete the study specific questionnaires.

Exclusion Criteria:

  • Treatment with nintedanib for more than 7 days prior to study enrolment.
  • Patients receiving a combination therapy of nintedanib & pirfenidone for IPF.
  • Patients that meet any of the contraindications to the administration of the study drug nintedanib according to the approved SmPC.
  • Prior treatment with pirfenidone or other treatment for IPF.
  • Participation in an interventional study.
  • Patients currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the initiation of therapy with 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): NCT03710824


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

Locations
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Greece
Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med. Recruiting
Athens, Greece, 11527
Contact: Demosthenes Bouros    +302107763559    debouros@gmail.com   
General Hospital of Kerkyra Recruiting
Kerkyra, Greece, 49100
Contact: Ilias Papanikolaou    +302661360694    icpapanikolaou@hotmail.com   
General University Hospital of Larissa Recruiting
Larissa, Greece, 41110
Contact: Zoe Daniil    +302413502898    zdaniil@med.uth.gr   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03710824     History of Changes
Other Study ID Numbers: 1199-0355
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http://trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

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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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Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action