NCT00507949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2006

Typical duration for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

2.5 years

First QC Date

July 26, 2007

Last Update Submit

June 7, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDbody weightmegestrol acetatecytokines

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Megestrol acetate

2

PLACEBO COMPARATOR

The placebo is the excipient of the experimental drug.

Drug: placebo

Interventions

Megestrol acetateDRUG

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

1
placeboDRUG

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

2

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neumology Service of the Hospital Universitario Dr. Peset

Valencia, Valencia, 46017, Spain

Location

Related Publications (1)

  • 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.

    PMID: 21524765RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBody Weight

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Herrejon Alberto, MD

    Hospital Universitario Dr. Peset, Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 27, 2007

Study Start

October 1, 2006

Primary Completion

April 1, 2009

Study Completion

September 1, 2009

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

ES(1)