Study to Evaluate the Effect of Megestrol Acetate in Severe Chronic Obstructive Pulmonary Disease With Loss of Weight

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Trial,Comparative With Placebo, Double Blind, to Evaluate the Effect of the Treatment With 320 mg/d of Megestrol Acetate in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) and Loss of Body Weight. Pilot Study

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Megestrol acetate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnose of COPD (criteria ATS/ERS 2004) Clinical stability more than 3 months Smokers or ex-smokers of more than > 10 boxes/year than do not modify their smoking habit during the study. FEV1 (post-bronchodilator) < 50%. FEV1/FVC ≤ 70 Negative answer to bronchodilator(≤ 20% del FEV1 o ≤ 200 ml.after 400 mcg.de salbutamol inhaled) BMI < 21 Kg/m2 ó BMI 21-25 Kg/m with loss weight of 5% of the habitual body weight in the last 3 months, without other reason that could explain it independently of the COPD. Exclusion Criteria: Use of nasogastric catheter Concomitant treatment with steroid, anabolics or other progestagens. Loss of body weight related with other causes: hyperthyroidism, enteral malnutrition ( Crohn disease...), neoplasias,etc Treatment with Megestrol Acetate in the last 6 months

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Megestrol acetate: sachets of granulated 160 mg. Dose: 160 mg/b.i.d. Duration 8 weeks | Drug: Megestrol acetate<br>* Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks.<br>|
| Placebo Comparator: 2<br>The placebo is the excipient of the experimental drug. | Drug: placebo<br>* sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate if the gain of weight is correlated with an improvement of the functional respiratory parameters |  | 8 weeks | 
| Evaluate if the gain of weight is related with an improvement in the quality of life of the patients. |  | 8 weeks | 
| Evaluate the changes in the inflammatory parameters (IL-6, TNF alfa...)and nutritional ones (Albumin and prealbumin) |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, body weight, megestrol acetate, cytokines