NCT00507949

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rottapharm Spain · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Megestrol acetate	Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks.
DRUG	placebo	sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-04-01
• Completion: 2009-09-01
• First posted: 2007-07-27
• Last updated: 2011-06-08

Locations

1 site across 1 country: Spain