The purpose of this trial is to study the effect of megestrol acetate in the gain of body weight in patients with severe Chronic obstructive pulmonary disease in order to improve the survival of the patients.
It has been demonstrated that the body weight measured as a Body mass index (BMI)is an independent risk factor of mortality in the severe COPD.It seems to be one influence of inflammatory factors in the development of denutrition in these patients. The use of especial diets has no so good results in the aim to improve the weight, being necessary to complement with muscular rehabilitation or anabolic products. The megestrol acetate has demonstrated good results in a short period of time, nevertheless the studies are scarce. The beneficial effects of the megestrol acetate seems to be mediated by cytokines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks.
sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.
Neumology Service of the Hospital Universitario Dr. Peset
Valencia, Valencia, Spain
To demonstrate if the Megestrol Acetate administered in dose of 320 mg/d could produce a significative increase of body weight in patients with severe COPD with loss of weight without any known reason in the last 3 months.
Time frame: 8 weeks
Evaluate if the gain of weight is correlated with an improvement of the functional respiratory parameters
Time frame: 8 weeks
Evaluate if the gain of weight is related with an improvement in the quality of life of the patients.
Time frame: 8 weeks
Evaluate the changes in the inflammatory parameters (IL-6, TNF alfa...)and nutritional ones (Albumin and prealbumin)
Time frame: 8 weeks
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