Chronic Obstructive Pulmonary Disease Clinical Trial
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
Verified date | June 2011 |
Source | Rottapharm Spain |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
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 รณ 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Neumology Service of the Hospital Universitario Dr. Peset | Valencia |
Lead Sponsor | Collaborator |
---|---|
Rottapharm Spain |
Spain,
Herrejón A, Palop J, Inchaurraga I, López A, Bañuls C, Hernández A, Blanquer R, Están 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] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Evaluate if the gain of weight is correlated with an improvement of the functional respiratory parameters | 8 weeks | No | |
Secondary | Evaluate if the gain of weight is related with an improvement in the quality of life of the patients. | 8 weeks | No | |
Secondary | Evaluate the changes in the inflammatory parameters (IL-6, TNF alfa...)and nutritional ones (Albumin and prealbumin) | 8 weeks | No |
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