The efficacy of anamorelin in patients with cachexia associated with chronic obstructive pulmonary disease

JRCT ID: jRCTs031230446

Registered date:13/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cachexia associated with chronic obstructive pulmonary disease
• Date of first enrollment: 13/11/2023
• Target sample size: 28
• Study type: Interventional
• Intervention(s): Anamorelin 100mg is administered orally once daily on an empty stomach, at least one hour before breakfast, daily for 12 weeks.

Outcome(s)

• Primary Outcome: Proportion of patients who maintained or increased lean body mass from baseline at Day85

Secondary Outcome

Change from baseline in the following items at Days 29, 57, 85 and 141(only for Day 85 in 7))
1) lean body mass 2) body weight 3) Grip strength 4) COPD assessment test 5) Geriatric depression scale 6) Council on Nutrition Appetite Questionnaire into Japanese 7) Forced expiratory volume in one second, Forced vital capacity

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Adults 18years of age or older at the time of consent
2) Patients diagnosed with COPD
3) Patients with non-arbitrary wight loss of 2% or more within 3-6 months, or BMI<21kg/m2
4) Patients who meet one or more criterias of following three
a. Anorexia
b. Decreased grip strength (<28kg in men and <18kg in women)
c. CRP > 0.5mg/dL
5) Patients receiving appropriate pharmacological therapy for COPD
6) Patients who have been informed of the study and who have given written consent of their own free will

Exclude criteria

1) Patients who have been introduced to new inhalation or nutritional therapy during the period from 4 weeks prior to the start of the study to the start of the study
2) Poorly controlled diabetes mellitus
3) Patients with the following contraindications to anamorelin administration
a. Patients with a history of hypersensitivity to anamorelin
b. Patients with congestive heart failure
c. Patients with myocardial infarction or angina pectoris
d. Patients with severe conduction defects (e.g., complete atrioventricular block)
e. Patients receiving the following drugs (clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir-containing products, cobicistat-containing products)
f. Hepatic dysfunction of moderate severity or greater (Child-Pugh Classification B or C)
g. Patients with difficulty in oral intake of food due to gastrointestinal obstruction or other organic abnormalities of the gastrointestinal tract.
4) Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating.
5) Other patients whom the investigator determines to be unsuitable for the safe conduct of this study.

Related Information

• Primary Sponsor: Ikari Jun
• Secondary Sponsor: Suzuki Takuji
• Source(s) of Monetary Support: Clinical Research Initiation-Fund of Chiba University Hosptal