To evaluate SUN11031 for subcutaneous injection compared to placebo in subjects with cachexia associated with Chronic Obstructive Pulmonary Disease (COPD) to determine the effect on physical performance and body composition.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

Each participant had to meet the following criteria to be enrolled in the study:
Male or non-pregnant female participants 50 years or older with a clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for greater than or equal to 12 months
Walked a distance of greater than or equal to 100 but less than or equal to 450 meters during the 6-Minute Walk Test (MWT) performed at screening.
Chest x-ray within the past year that was compatible with COPD
Documented involuntary nonedematous weight loss of greater than 5% of participant's usual body weight over the past 12 months or BMI less than or equal to 21 kg/m\^2 for males or Body Mass Index (BMI) less than or equal to 20 kg/m\^2 for females
Female participants who were clinically sterile (eg, either postmenopausal or had undergone a tubal ligation or hysterectomy) or were practicing a medically acceptable method of birth control (eg, oral, transdermal, implantable, or injectable contraceptive medications; double-barrier method or intrauterine device)

Criterios de exclusión

Participants who met any of the following criteria were excluded from the study:
BMI greater than 26 kg/m\^2
Used, over a total of 7 or more days, parenteral corticosteroids at a dose equivalent to prednisone at greater than or equal to 5 mg/day or oral corticosteroids at a dose equivalent to prednisone at greater than 10 mg/day within the 2 months before screening; however, participants were allowed to participate if on stable doses equivalent to prednisone at less than or equal to 10 mg/day for at least 2 months before screening, and were planning to remain on the same stable dose throughout the study
Were planning to start a pulmonary rehabilitation program during the study (participant may have been enrolled in the study if he or she was currently on a stable maintenance program)
Weight loss that was considered to be, in the opinion of the investigator, the result of food deprivation
Unintended weight loss that may have been due to disease other than COPD
Unable or unwilling to be trained to self-administer the study drug by subcutaneous injection bid, and for whom arrangements could not be made for a third party to reliably administer the injections
Severe anemia (hemoglobin less than or equal to 8 g/dL)
COPD exacerbation defined as a Type 1 or 2 exacerbation according to the Winnipeg criteria, acute infection, or prolonged fever within 4 weeks before screening
Undergoing treatment or evaluation for cancer, or had a history of treatment for cancer within the past 3 years, exception being nonmelanoma skin cancer (basal cell or squamous cell carcinoma of the skin) and carcinoma in situ of the cervix
Type I or type II diabetes mellitus or a fasting serum glucose of greater than or equal to 115 mg/dL (6.4 mmol/L) (fasting was overnight)
Serious disease or conditions that would have interfered with the participant's ability to complete the functional measures included in this protocol; or any illness that, in the opinion of the investigator, might have interfered with the results of the study or the participant's ability to participate
Pulmonary embolism, deep venous thrombosis, or clinically significant primary pulmonary hypertension within the past 6 months
Significant ischemic heart disease or chronic heart failure (New York Heart Association Class IV cardiac disease)
Uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 110 mm Hg)
A history of symptomatic orthostatic hypotension or syncope; or orthostatic hypotension at screening or baseline (Days -6 to -3) (orthostatic hypotension was defined as a decrease in systolic blood pressure by greater than or equal to 20 mm Hg measured after 2 minutes in a standing position compared with the systolic blood pressure measured after 10 minutes in a supine position)
Evidence of ascites, pleural effusion, or lower extremity edema
Severe vitamin D deficiency (25-hydroxyvitamin D less than 10 ng/mL)
Known mechanical obstruction of the alimentary tract and/or malabsorption
Dental or swallowing problems that may have had a negative effect on food intake
Serum creatinine greater than 2.5 mg/dL; or alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase greater than 3 times the upper limit of normal, or bilirubin greater than 2.5 mg/dL
A diagnosis of human immunodeficiency virus infection or AIDS
Used any prescription drugs and non-prescription drugs/herbs that cause weight loss or affect appetite and absorption or that may cause nausea; or used appetite-promoting or anabolic medications within 15 days before screening
A history of alcohol or drug abuse that, in the opinion of the investigator, would have interfered with the participant's ability to comply with the dosing schedule and protocol-specified requirements
Hypersensitive to any component of SUN11031, or participated at any time in any study in which SUN11031 was administered
Received an investigational drug or product, or participated in a drug study within 30 days before screening
Non-ambulatory or unwilling to cooperate fully with the investigator or a designee, or unwilling or unable to comply with study requirements, such as all assessments required by the protocol, including completion of measures for functional capacity and pulmonary function, or frequent blood sampling and meal instructions; or unable or unwilling to attend all study visits

Ubicaciones

Centro de Investigaciones Médicas

Florencío Varela, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Centro Respiratorio Quilmes

Quilmes, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Cipolletti

Cipolletti, Río Negro Province, Argentina

Clinica del Tórax

Rosario, Santa Fe Province, Argentina

Instituto Cardiovascular de Rosario

Rosario, Santa Fe Province, Argentina

CEMIT

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigación Médica Lanús

Buenos Aires, Argentina

FAICEP

Capital Federal, Argentina

Instituto Médico de Asistencia e Investigación

Capital Federal, Argentina

Centro Médico Dra. De Salvo

Capital Federal, Argentina

Centro Médico Belgrano

Capital Federal, Argentina

Centro Ceri

Capital Federal, Argentina

Centro de Estudios Neumonologicos

Capital Federal, Argentina

Fuesmen

Mendoza, Argentina

Instituto de Enfermedades Respiratorias

Mendoza, Argentina

Centro de Medicina Respiratoria

Paraná, Argentina

Instituto de Patologia Respiratoria

San Miguel de Tucumán, Argentina

A Phase 2b, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SUN11031 for Injection Administered Subcutaneously Twice Daily for 12 Weeks to Subjects Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Placebo comparator

SUN11031 20 μg/kg

SUN11031 40 μg/kg

Ubicaciones

Centro de Investigaciones Médicas

Instituto de Investigaciones Clinicas Mar del Plata

Centro Respiratorio Quilmes

Instituto de Investigaciones Clínicas Cipolletti

Clinica del Tórax

Instituto Cardiovascular de Rosario

CEMIT

Centro de Investigación Médica Lanús

FAICEP

Instituto Médico de Asistencia e Investigación

Centro Médico Dra. De Salvo

Centro Médico Belgrano

Centro Ceri

Centro de Estudios Neumonologicos

Fuesmen

Instituto de Enfermedades Respiratorias

Centro de Medicina Respiratoria

Instituto de Patologia Respiratoria

Patrocinadores