Phase 3
N=344
Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00287729 ↗Enrolled (actual)
344
Serious AEs
30.2%
Results posted
Jun 2011
Primary outcome: Primary: Absolute Change in Percent Predicted Forced Vital Capacity(FVC) — -9; -10 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) |
-9; -10 | — |
| SECONDARY Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity |
20; 23; 19; 23; 88; 89 | — |
| SECONDARY Progression-free Survival |
54; 60; 31; 41; 10; 9 | — |
| SECONDARY Change in the Six-Minute Walk Test (6MWT) Distance |
-45; -77 | — |
| SECONDARY Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test |
-1.9; -1.3 | — |
| SECONDARY Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs |
-9.8; -9.2 | — |
| SECONDARY Change in Dyspnea Score |
11.9; 13.9 | — |
| SECONDARY Worsening of IPF |
24; 32; 2; 1; 3; 6 | — |
Summary
The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared with placebo 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 ≥ 50% predicted value
- carbon monoxide diffusing capacity (DLco) ≥ 35% predicted value
- either Forced Vital Capacity or carbon monoxide diffusing capacity (DLco) ≤ 90% predicted value
- no improvement in past year
- able to walk 150 meters in 6 minutes and maintain saturation ≥ 83% while on no more than 6 liters per minute supplemental oxygen
Primary Exclusion criteria:
- unable to undergo pulmonary function testing
- evidence of significant obstructive lung disease or airway hyper-responsiveness
- in the clinical opinion of the investigator, the patient is expected to need and be eligible for a lung transplant within 72 weeks of 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 syndrome
- other IPF treatment
- unable to take study medication
- withdrawal from other IPF trials
Data sourced from ClinicalTrials.gov (NCT00287729). 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.