Skip to main content
OpenTrials
Completed

NCT Number: NCT00507949

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Body Weight Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neumology Service of the Hospital Universitario Dr. Peset

Valencia, 46017, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Megestrol acetate

Drug

Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks.

Placebo

Drug

sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluate if the gain of weight is correlated with an improvement of the functional respiratory parameters

    Time frame: 8 weeks

  2. Evaluate if the gain of weight is related with an improvement in the quality of life of the patients.

    Time frame: 8 weeks

  3. Evaluate the changes in the inflammatory parameters (IL-6, TNF alfa...)and nutritional ones (Albumin and prealbumin)

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Rottapharm Spain

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jul 27, 2007
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.