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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00507949
Recruitment Status : Completed
First Posted : July 27, 2007
Last Update Posted : June 8, 2011
Information provided by:
Rottapharm Spain

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Megestrol acetate Drug: placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : October 2006
Primary Completion Date : April 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
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
First Posted: July 27, 2007    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 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
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants