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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rottapharm Spain
• Treatments: Megestrol; Megestrol Acetate

Criteria

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