(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF
- Registration Number
- NCT00768300
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 494
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Ambrisentan Ambrisentan -
- Primary Outcome Measures
Name Time Method Time to Death or Disease (IPF) Progression. Up to 48 months 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
- Secondary Outcome Measures
Name Time Method Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36) Baseline and Week 48 The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state.
Proportion of Participants With No Disease Progression or Death at 48 Weeks Baseline and Week 48 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.
Change in 6MWT at Week 48 Baseline and Week 48 The 6MWT is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
Change in FVC % Predicted at Week 48 Baseline and Week 48 FVC is defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted is defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.
Change in DLCO % Predicted at Week 48 Baseline and Week 48 DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood. DLCO % predicted is defined as DLCO % of the participant divided by the average DLCO % in the population for any person of similar age, sex and body composition.
Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George's Respiratory Questionnaire (SGRQ) Baseline and Week 48 The SGRQ is designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. The range of each score is 0-100, with 0 indicating fewer limitations and 100 indicating more limitations; an increase in score indicates an increase in limitations.
Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI) Baseline and Week 48 The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A TDI score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.
Percentage of Participants Who Developed PH on Study Up to 48 weeks The percentage of participants known to have developed pulmonary hypertension on study documented by right heart catheterization (RHC) was analyzed. RHC was done at baseline and 48 weeks, or at the early termination visit.
Trial Locations
- Locations (27)
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Bay Area Chest Physicians
🇺🇸Clearwater, Florida, United States
Pulmonary Associates
🇺🇸Phoenix, Arizona, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The Oregon Clinic, P.C.
🇺🇸Portland, Oregon, United States
National Jewish Medical And Research Center
🇺🇸Denver, Colorado, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Alabama at Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center)
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Stanford, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Saint Lukes Foundation
🇺🇸Chesterfield, Missouri, United States
Dartmouth Medical School
🇺🇸Lebanon, New Hampshire, United States
Pulmonary & Allergy Associates
🇺🇸Summit, New Jersey, United States
Pulmonary And Critical Care Services, P.C.
🇺🇸Albany, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Pennsylvania Health Systems
🇺🇸Philadelphia, Pennsylvania, United States
The Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Complejo Asistencial Universitario de León
🇪🇸Leon, Castilla, Spain
Hospital Virgen del Rocio
🇪🇸Sevilla, Andalucia, Spain
Kentuckiana Pulmonary Association
🇺🇸Louisville, Kentucky, United States
University of California, Davis
🇺🇸Sacramento, California, United States