(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF

Phase 3TerminatedNCT00768300

Gilead Sciences494 enrolled

Overview

The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

494

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or females from 40 to 80 years of age * Diagnosis of IPF * Honeycombing (fibrosis in the lung) on high-resolution computerised tomography (HRCT) scan of less than or equal to 5% * Willing and able to have 2 right heart catheterizations performed * Willing to have monthly lab tests to monitor liver function * Able to perform the 6 minute walk test (indicated adequate physical function) * Must have meet lung function requirements * Normal liver function tests * Negative serum pregnancy test * Willing to use at least 2 reliable methods of contraception * Able to understand and willing to sign informed consent form Exclusion Criteria: * No restrictive lung disease (other than usual interstitial pneumonia or IPF) * No obstructive lung disease * No recent or active respiratory exacerbations * No recent hospitalization for an IPF exacerbation * No recent history of alcohol abuse * Chronic sildenafil (or same drug class) use for pulmonary hypertension * Chronic treatment with certain medications for IPF within 30 days of randomization * No other serious medical conditions

Locations (185)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, United States

Pulmonary Associates

Phoenix, Arizona, United States

Unnamed facility

Scottsdale, Arizona, United States

David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center)

Los Angeles, California, United States

University of California, Davis

Sacramento, California, United States

Outcomes

Primary Outcomes

Time to Death or Disease (IPF) Progression.

The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following: * Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days * Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan * All-cause mortality

Time frame: Up to 48 months

Secondary Outcomes

Proportion of Participants With No Disease Progression or Death at 48 Weeks

The proportion of participants with no disease progression or death is presented as a percentage using a Kaplan-Meier (KM) estimate of survival or not experiencing disease progression.