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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: placebo; Drug: Megestrol acetate

• Registration Number: NCT00507949
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-07-26
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-27
• Primary Completion: 2009-04
• Study Completion: 2009-09
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	The placebo is the excipient of the experimental drug.
1	Megestrol acetate	Megestrol acetate: sachets of granulated 160 mg. Dose: 160 mg/b.i.d. Duration 8 weeks

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Evaluate if the gain of weight is correlated with an improvement of the functional respiratory parameters	8 weeks
Evaluate if the gain of weight is related with an improvement in the quality of life of the patients.	8 weeks
Evaluate the changes in the inflammatory parameters (IL-6, TNF alfa...)and nutritional ones (Albumin and prealbumin)	8 weeks

Trial Locations

Locations (1)

Neumology Service of the Hospital Universitario Dr. Peset; 🇪🇸 Valencia, Spain