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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Megestrol acetate

placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, body weight, megestrol acetate, cytokines

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Neumology Service of the Hospital Universitario Dr. Peset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Megestrol acetate: sachets of granulated 160 mg. Dose: 160 mg/b.i.d. Duration 8 weeks

The placebo is the excipient of the experimental drug.

Outcomes

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.

Secondary Outcome Measures

Evaluate if the gain of weight is correlated with an improvement of the functional respiratory parameters

Evaluate if the gain of weight is related with an improvement in the quality of life of the patients.

Evaluate the changes in the inflammatory parameters (IL-6, TNF alfa...)and nutritional ones (Albumin and prealbumin)

Full Information

NCT ID

NCT00507949

First Posted

July 26, 2007

Last Updated

June 7, 2011

Sponsor

Rottapharm Spain

1. Study Identification

Unique Protocol Identification Number

NCT00507949

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rottapharm Spain

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD, body weight, megestrol acetate, cytokines

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Megestrol acetate: sachets of granulated 160 mg. Dose: 160 mg/b.i.d. Duration 8 weeks

Arm Title

Arm Type

Placebo Comparator

Arm Description

The placebo is the excipient of the experimental drug.

Intervention Type

Drug

Intervention Name(s)

Megestrol acetate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Evaluate if the gain of weight is correlated with an improvement of the functional respiratory parameters

Time Frame

8 weeks

Title

Evaluate if the gain of weight is related with an improvement in the quality of life of the patients.

Time Frame

8 weeks

Title

Evaluate the changes in the inflammatory parameters (IL-6, TNF alfa...)and nutritional ones (Albumin and prealbumin)

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Herrejon Alberto, MD

Organizational Affiliation

Hospital Universitario Dr. Peset, Valencia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neumology Service of the Hospital Universitario Dr. Peset

City

Valencia

ZIP/Postal Code

46017

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

21524765

Citation

Herrejon A, Palop J, Inchaurraga I, Lopez A, Banuls C, Hernandez A, Blanquer R, Estan 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]. Med Clin (Barc). 2011 Jul 23;137(5):193-8. doi: 10.1016/j.medcli.2011.02.016. Epub 2011 Apr 27. Spanish.

Results Reference

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

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