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

This study has been completed.
Information provided by:
Rottapharm Spain Identifier:
First received: July 26, 2007
Last updated: June 7, 2011
Last verified: June 2011
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Megestrol acetate
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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

Resource links provided by NLM:

Further study details as provided by Rottapharm Spain:

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

Estimated Enrollment: 40
Study Start Date: October 2006
Study Completion Date: September 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Drug: placebo
sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.

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.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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
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Please refer to this study by its identifier: NCT00507949

Neumology Service of the Hospital Universitario Dr. Peset
Valencia, Spain, 46017
Sponsors and Collaborators
Rottapharm Spain
Principal Investigator: Herrejon Alberto, MD Hospital Universitario Dr. Peset, Valencia
  More Information

Responsible Party: Anna Anguera, Research Manager, Madaus, S.A. Identifier: NCT00507949     History of Changes
Other Study ID Numbers: BO-EC-EPOC-01
EudraCT number:2005-005148-16
Study First Received: July 26, 2007
Last Updated: June 7, 2011

Keywords provided by Rottapharm Spain:
body weight
megestrol acetate

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Megestrol Acetate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents processed this record on April 28, 2017