None listed
Conditions
Interventions
Group 1 Type of group
Ambrisentan (5mg or 10 mg tablet) was administered orally once daily.
Group name:Group 2 Type of group
Placebo to match ambrisentan was administered orally once daily.
Sponsors
GILEAD SCIENCES, INC.,
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Men or women between 40 and 80 years old • Diagnosis of idiopathic pulmonary fibrosis (IPF) based on the criteria established in the ATS-ERS guidelines for the diagnosis of PF • Bees panel pattern 50 and 0.7. Pulmonary function tests must be completed no more than 90 days before enrollment • Ability to submit and complete the 6MWT in the selection • In the case of women with the ability to procreate, serum negative pregnancy test in the selection and negative urine pregnancy test in randomization (defined in section 6.3). • Women with the ability to procreate must be willing to use at least two reliable contraceptive methods during their entire participation in the study and during the 30 days following the IMP suspension, except for women previously undergoing tubal ligation or insertion of an intrauterine device (IUD) Copper T 380A or LNg 20, in which case no other contraceptive method is necessary. Women with the ability to procreate should also be willing to undergo pregnancy tests every 28 days. • Male subjects should be able to understand and recognize the possible risks of testicular tubular atrophy and sterility associated with taking this IMP as described in the informed consent form (ICF) • Competence to understand the information provided in the ICF approved by the Institutional Review Board (IRB) or the Independent Ethics Committee. Subjects must sign the form before any study procedure is initiated, unless the evaluation is performed as part of the normal care for this disease.
Exclusion criteria
Exclusion criteria: • Diagnosis of any ILD or restrictive lung disease other than IPU or IPF. • Obstructive pulmonary disease as determined by signs of airflow obstruction in HRCT • Signs of sustained improvement in the status of the IPF defined as improvement over pretreatment PFPs in two or more successive post-treatment PFPs during the year prior to randomization • Disease (s) that constitute a contraindication for RHC: Tricuspid or pulmonary valve stenosis, Prosthetic tricuspid or pulmonary valves, Right atrial or ventricular mass, Cyanotic heart disease, Latex or catheter material allergy, Pneumonectomy previous. • Active or recent upper respiratory or pulmonary infection ( 20 mg / day of prednisone or equivalent), immunosuppressants or cytotoxic, antifibrotic, chronic use of N-acetylcysteine ​​(prescribed for the F). • Acute or chronic deterioration (other than dyspnea) that limits the ability to meet the requirements and procedures of the study, including 6MWT • Treatment with ambrisentan in a clinical study or as a commercial product • Treatment with an approved or experimental ERA within 30 days prior to randomization • Chronic use of sildenafil or another phosphodiesterase type 5 inhibitor (PDE-5) for pulmonary hypertension • Chronic treatment with immunosuppressants, cytotoxic or antifibrotic such as pirfenidone, D-penicillamine, colchicine, TNF-a antagonists, imatinib, gamma interferon, cyclophosphamide, cyclosporine A or azathioprine within 30 days prior to randomization (section 5.4) • Previous treatment with suspended ERA due to any side effects • ALT or AST> 1.5 x ULN in the selection • Hemoglobin concentration 2.5 mg / dL (221 umol / L) or need for hemodialysis, peritoneal dialysis or hemofiltration • Systolic blood pressure <85 mm Hg • History of cancer in the last 5 years, except for basal cell carcinoma of the skin or cervical carcinoma in situ successfully treated • Pregnant or breastfeeding woman • Known history of alcoholism in the year prior to enrollment • Participation in any clinical study of another drug or experimental device in the 28 days prior to selection • Status of comorbidity or concomitant disease that limits life expectancy to <1 year at the time of selection • Serious or active medical or psychiatric illness that, in the opinion of the investigator, could interfere in the treatment of the subject, in its evaluation or in compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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 Measure:Time to Death or Disease (IPF) Progression. Timepoints:Up to 48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Proportion of Participants With No Disease Progression or Death at 48 Weeks Timepoints:Baseline and Week 48 ; Outcome name: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. Measure:Change in FVC % Predicted at Week 48 Timepoints:Baseline and Week 48 ; Outcome name: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. Measure:Change in DLCO % Predicted at Week 48 Timepoints:Baseline and Week 48 ; Outcome name: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. Measure:Change in 6MWT at Week 48 Timepoints:Baseline and Week 48 ; Outcome name: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. Measure:Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36) Timepoints:Baseline and Week 48 ; Outcome name: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. M | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, France, Germany, Ireland, Israel, Italy, Mexico, Netherlands, Poland, Spain, Sweden, United Kindgdom, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed