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Quality of Life Study in Participants With IPF Under Pirfenidone Treatment (PNEUMON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115619
Recruitment Status : Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multicenter, post-marketing, observational study will evaluate quality of life in participants with Idiopathic Pulmonary Fibrosis (IPF) under treatment with pirfenidone (Esbriet).

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

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Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Quality of Life in Patients in Greece With Idiopathic Pulmonary Fibrosis Under Treatment With Pirfenidone - The Pneumon Study
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020


Group/Cohort Intervention/treatment
Participants With IPF
Observational data of participants with IPF under treatment with pirfenidone will be collected from the medical records as a part of their routine clinical visits at 12-week interval until study completion or early withdrawal (up to Week 52).
Drug: Pirfenidone
Participants will receive pirfenidone therapy as per clinical practice or summary of product characteristics (SmPC).
Other Name: Esbriet




Primary Outcome Measures :
  1. Change From Baseline in Quality of Life of Participants as Assessed by Saint George's Respiratory Questionnaire (SGQR) Score at the End of Treatment [ Time Frame: Baseline, end of treatment (up to Week 52) ]

Secondary Outcome Measures :
  1. Change From Baseline in Dyspnoea as Assessed by Medical Research Council (MRC) Breathlessness Scale Level at the End of Treatment [ Time Frame: Baseline, end of treatment (up to Week 52) ]
  2. Change From Baseline in Percent (%) Predicted Forced Vital Capacity (FVC) at the End of Treatment [ Time Frame: Baseline, end of treatment (up to Week 52) ]
  3. Change From Baseline in Annual FVC [ Time Frame: From Baseline up to end of treatment (up to Week 52) ]
  4. Change From Baseline in % Predicted Diffusing Lung Capacity for Carbon Monoxide (DLCO) at the End of Treatment [ Time Frame: Baseline, end of treatment (up to Week 52) ]
  5. Percentage of participants With Acute IPF Exacerbations, IPF-Related Death, Lung Transplant, or Respiratory-Related Hospitalization [ Time Frame: from Baseline up to end of treatment (up to Week 52) ]
  6. Percentage of Participants who are Compliant to Treatment [ Time Frame: From Baseline up to end of treatment (up to Week 52) ]
    Treatment compliance will be assessed by the total number of dose reductions, dose interruptions, and the administered dosing intensity relative to the projected dose intensity during treatment.

  7. Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interests [ Time Frame: From Baseline up to end of treatment (up to Week 52) ]


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
Participants in Greece with IPF under treatment with pirfenidone.
Criteria

Inclusion Criteria:

  • Adult participants for whom pirfenidone has already been prescribed for IPF no more than 4 weeks prior to enrollment, according to their physicians' clinical decision and the terms in the SmPC

Exclusion Criteria:

  • Participants who are participating in an interventional study or have received any investigational agent in the past 4 weeks

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): NCT03115619


Locations
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Greece
Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology
Athens, Greece, 115 27
University General Hospital of Athens "Attikon", B' University Pulmonary Clinic
Chaidari, Greece, 124 62
University General Hospital of Heraklio, Pulmonary Clinic
Heraklio, Greece, 711 10
University General Hospital of Ioannina
Ioannina, Greece, 455 00
General University Hospital of Larisa; Pneumonology Clinic
Larissa, Greece, 413 34
General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.
Thessaloniki, Greece, 570 10
Papanikolaou Hospital; Pneumonology Clinic
Thessaloniki, Greece, 570 10
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03115619    
Other Study ID Numbers: ML39259
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents