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OpenTrials
Completed

NCT Number: NCT02622477

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

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).

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxis Dr. med. Mathias Rolke und Dr. med. Peter Rückert, Aschaffenburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pirfenidone

Drug

This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • InterMune Deutschland GmbH

Registry information

Official study title

Clinical Course of Treatment With ESBRIET in Patients With Mild to Moderate IPF

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2015
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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