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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.
Sponsor:
Information provided by:
Rottapharm Spain
ClinicalTrials.gov Identifier:
NCT00507949
First received: July 26, 2007
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

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
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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507949

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

Publications:

Responsible Party: Anna Anguera, Research Manager, Madaus, S.A.
ClinicalTrials.gov 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
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Rottapharm Spain:
COPD
body weight
megestrol acetate
cytokines

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Megestrol
Megestrol Acetate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Appetite Stimulants
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013