Study to Evaluate the Effect of Megestrol Acetate in Severe Chronic Obstructive Pulmonary Disease With Loss of Weight
NCT ID: NCT00507949
Last Updated: 2011-06-08
Study Results
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Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2006-10-31
2009-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Megestrol acetate: sachets of granulated 160 mg. Dose: 160 mg/b.i.d. Duration 8 weeks
Megestrol acetate
Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks.
2
The placebo is the excipient of the experimental drug.
placebo
sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
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Rottapharm Spain
INDUSTRY
Responsible Party
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Madaus, S.A.
Principal Investigators
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Herrejon Alberto, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Dr. Peset, Valencia
Locations
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Neumology Service of the Hospital Universitario Dr. Peset
Valencia, Valencia, Spain
Countries
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References
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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.
Other Identifiers
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EudraCT number:2005-005148-16
Identifier Type: -
Identifier Source: secondary_id
BO-EC-EPOC-01
Identifier Type: -
Identifier Source: org_study_id
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