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NCT Number: NCT00287716

Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

InterMune, Inc.

Brisbane, California, 94005, United States

About this study

This is a Phase 3, randomized, double blind, placebo-controlled, three-arm, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis. Approximately 400 patients at approximately 70 centers will be randomly assigned (2:2:1) to receive either 2403 milligrams (mg) of pirfenidone, placebo equivalent, or 1197 mg of pirfenidone administered in divided doses three times per day (TID) with food. Patients will be randomized by geographic region.

Patients will receive blinded study treatment from the time of randomization until the last patient randomized has been treated for 72 weeks. A Data Monitoring Committee (DMC) will periodically review safety and efficacy data to ensure patient safety.

After week 72, patients who meet the Progression of Disease (POD) definition, which is a ≥ 10% absolute decrease in percent predicted FVC or a ≥ 15% absolute decrease in percent predicted carbon monoxide diffusing capacity (DLco), will be eligible to receive permitted IPF therapies in addition to their blinded study drug. Permitted IPF therapies include corticosteroids, azathioprine, cyclophosphamide and N-acetyl-cysteine (with restrictions).

Who can participate

Healthy volunteers accepted: No

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

Primary Inclusion criteria:

  • diagnosis of idiopathic pulmonary fibrosis
  • 40 to 80 years of age
  • Forced Vital Capacity greater than or equal to 50% predicted value
  • Carbon monoxide diffusing capacity greater than or equal to 35% predicted value
  • either Forced Vital Capacity or Carbon monoxide diffusing capacity less than or equal to 90% predicted value
  • no improvement in past year
  • able to walk 150 meters in 6 minutes and maintain saturation greater than or equal to 83% while on no more than 6 liters per minute (L/min) supplemental oxygen

Primary Exclusion criteria:

  • unable to undergo pulmonary function testing
  • evidence of significant obstructive lung disease or airway hyper-responsiveness
  • in opinion of investigator patient is expected to need and be eligible for a lung transplant within 72 weeks after randomization
  • active infection
  • liver disease
  • cancer or other medical condition likely to result in death within 2 years
  • diabetes
  • pregnancy or lactation
  • substance abuse
  • personal or family history of long QT (Q wave,T wave) syndrome
  • other IPF treatment
  • unable to take study medication
  • withdrawal from other IPF trials

Treatment and study plan

pirfenidone

Drug

1197 or 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study.

Placebo

Drug

Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.

Primary outcomes

  1. Absolute Change in Percent Predicted Forced Vital Capacity (FVC)

    Time frame: From baseline up to 72 weeks

    Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72.

Secondary outcomes

  1. Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)

    Time frame: baseline up to 72 weeks

    Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experienced a Categorical Change in Percent Predicted Forced Vital Capacity.

  2. Progression-free Survival (PFS)

    Time frame: Baseline to Week 72

    Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.

  3. Change in Six-Minute Walk Test (6MWT)Distance

    Time frame: Baseline to Week 72

    The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test as measured in meters (m).

  4. Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test

    Time frame: Baseline to Week 72

    The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.

  5. Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs

    Time frame: Baseline to Week 72

  6. Change in Dyspnea Score

    Time frame: Baseline to Week 72

    The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5), with 0 = not at all breathless, 4= severely breathless and 5 = Maximally or unable to do because of breathlessness.

  7. Worsening of Idiopathic Pulmonary Fibrosis (IPF)

    Time frame: Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.

    Worsening of IPF was defined by the occurrence of any of the following events:

    Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 7, 2006
Registry last updated
May 22, 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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