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Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet® (Pirfenidone)

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ClinicalTrials.gov Identifier: NCT02622477
Recruitment Status : Completed
First Posted : December 4, 2015
Last Update Posted : February 28, 2017
Sponsor:
Collaborator:
InterMune Deutschland GmbH
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
The purpose of the study was to assess the clinical outcome of patients with a mild to moderate IPF after a one-year therapy with Esbriet® (Pirfenidone).

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

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Course of Treatment With ESBRIET in Patients With Mild to Moderate IPF
Study Start Date : June 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Group/Cohort Intervention/treatment
Participants with idiopathic pulmonary fibrosis
Participants with idiopathic pulmonary fibrosis receiving Pirfenidone will be observed for treatment responses.
Drug: Pirfenidone
This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration.




Primary Outcome Measures :
  1. Categorical Decrease Of The Vital Capacity And Forced Volume Capacity (>= 5 % Respectively 10% Compared To The Previous Examination Findings) Under Treatment [ Time Frame: -3 to 8 months before inclusion, appointment 0, and 3, 6, 9 and 12 months after appointment ]
  2. Categorical Decrease of the 6-Minute Walking Distance (>= 50 Metres Compared to the Previous Examination Findings) Under Treatment [ Time Frame: Appointment 0, and 3, 6, 9 and 12 months after appointment 0 ]
  3. Disease Progression [ Time Frame: Appointment 0, and 3, 6, 9 and 12 months after appointment 0 ]

Secondary Outcome Measures :
  1. Progression of the LCQ (Leicester Cough Questionnaire) [ Time Frame: Appointment 0, and 3, 6, 9 and 12 months after appointment 0 ]
  2. Progression of the SOBQ (Shortness of Breath Questionnaire) [ Time Frame: Appointment 0, and 3, 6, 9 and 12 months after appointment 0 ]
  3. Proportion of the Participants With Exacerbations [ Time Frame: Appointment 0, and 3, 6, 9 and 12 months after appointment 0 ]
  4. Cases Of Death (All, Idiopathic Pulmonary Fibrosis Associated) [ Time Frame: Up to 12 months ]
  5. Proportion of the Participants, who After the 3 Week Titration Phase Receive the Full Maintenance Dosage Of Pirfenidone [ Time Frame: 3, 6, 9 and 12 months after appointment 0 ]
  6. Dosage of Pirfenidone [ Time Frame: Up to 12 months ]
  7. Proportion of the Participants who Change the Dosage Of Pirfenidone [ Time Frame: Up to 12 months ]
  8. Reasons for the Dosage Change [ Time Frame: Up to 12 months ]
  9. Reasons for the Beginning, Change or Discontinuation of a Treatment of Comorbidities of Pirfenidone Associated Adverse Drug Reactions [ Time Frame: Up to 12 months ]
  10. Number of Participants With at Least one Adverse Drug Reaction Under the Therapy With Pirfenidone [ Time Frame: Up to 12 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF), who had previously not yet been treated with Pirfenidone
Criteria

Inclusion Criteria:

Adult patients with confident diagnosis of mild to moderate IPF, who had previously not yet been treated with Pirfenidone

Exclusion Criteria:

Hypersensitivity to the active substance or one of the other excipients of Pirfenidone Concomitant use of Fluvoxamin Severe hepatic impairment or end stage liver disease Severe renal impairment (Creatinine-Clearance <30 ml/min) or end stage renal disease requiring dialysis Simultaneous participation in interventional studies Previously treated with Pirfenidone for longer than 30 days


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): NCT02622477


Locations
Show Show 17 study locations
Sponsors and Collaborators
Hoffmann-La Roche
InterMune Deutschland GmbH
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02622477    
Other Study ID Numbers: ML30016
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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