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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507949
• Other study ID #: BO-EC-EPOC-01
• Secondary ID: EudraCT number:2
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2007
• Last updated: June 7, 2011
• Start date: October 2006
• Est. completion date: September 2009

Study information

• Verified date: June 2011
• Source: Rottapharm Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Megestrol acetate
Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks.
• placebo
sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.

Locations

Country	Name	City	State
Spain	Neumology Service of the Hospital Universitario Dr. Peset	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Rottapharm Spain

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Herrejón A, Palop J, Inchaurraga I, López A, Bañuls C, Hernández A, Blanquer R, Están N, Anguera A. [Low doses of megestrol acetate increase weight and improve nutrition status in patients with severe chronic obstructive pulmonary disease and weight loss] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		8 weeks	No
Secondary	Evaluate if the gain of weight is correlated with an improvement of the functional respiratory parameters		8 weeks	No
Secondary	Evaluate if the gain of weight is related with an improvement in the quality of life of the patients.		8 weeks	No
Secondary	Evaluate the changes in the inflammatory parameters (IL-6, TNF alfa...)and nutritional ones (Albumin and prealbumin)		8 weeks	No