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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00507949

Enrollment

Registered

2007-07-27

Start date

2006-10-31

Completion date

2009-09-30

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, body weight, megestrol acetate, cytokines

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.

Interventions

DRUGMegestrol acetate

Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks.

DRUGplacebo

sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026