Phase 3
N=435
Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00287716 ↗Enrolled (actual)
435
Serious AEs
33.6%
Results posted
Jun 2011
Primary outcome: Primary: Absolute Change in Percent Predicted Forced Vital Capacity (FVC) — -8.0; -10.0; -12.4 Change in Percent Predicted FVC
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pirfenidone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Percent Predicted Forced Vital Capacity (FVC) |
-8.0; -10.0; -12.4 | — |
| SECONDARY Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC) |
14; 9; 27; 21; 14; 33 | — |
| SECONDARY Progression-free Survival (PFS) |
45; 28; 62; 28; 16; 39 | 0.023 sig |
| SECONDARY Change in Six-Minute Walk Test (6MWT)Distance |
-60; -76; -77 | — |
| SECONDARY Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test |
-2; -1; -2 | — |
| SECONDARY Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs |
-8; -9; -10 | — |
| SECONDARY Change in Dyspnea Score |
12; 14; 15 | — |
| SECONDARY Worsening of Idiopathic Pulmonary Fibrosis (IPF) |
26; 10; 30 | 0.515 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00287716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.