Study to Evaluate the Effect of Megestrol Acetate in Severe Chronic Obstructive Pulmonary Disease With Loss of Weight
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.
Chronic Obstructive Pulmonary Disease
Drug: Megestrol acetate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- 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 ] [ Designated as safety issue: No ]
- Evaluate if the gain of weight is correlated with an improvement of the functional respiratory parameters [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Evaluate if the gain of weight is related with an improvement in the quality of life of the patients. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Evaluate the changes in the inflammatory parameters (IL-6, TNF alfa...)and nutritional ones (Albumin and prealbumin) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Megestrol acetate: sachets of granulated 160 mg. Dose: 160 mg/b.i.d. Duration 8 weeks
Drug: Megestrol acetate
Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks.
Placebo Comparator: 2
The placebo is the excipient of the experimental drug.
sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.
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.
|Neumology Service of the Hospital Universitario Dr. Peset|
|Valencia, Spain, 46017|
|Principal Investigator:||Herrejon Alberto, MD||Hospital Universitario Dr. Peset, Valencia|