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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number:2005-005148-16 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Megestrol acetate: sachets of granulated 160 mg. Dose: 160 mg/b.i.d. Duration 8 weeks |
|
| 2 | Placebo Comparator | The placebo is the excipient of the experimental drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Megestrol acetate | Drug | Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks. |
| |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herrejon Alberto, MD | Hospital Universitario Dr. Peset, Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neumology Service of the Hospital Universitario Dr. Peset | Valencia | Valencia | 46017 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21524765 | Result | 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D019290 | Megestrol Acetate |
| ID | Term |
|---|---|
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| placebo |
| Drug |
sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks. |
|
| Evaluate the changes in the inflammatory parameters (IL-6, TNF alfa...)and nutritional ones (Albumin and prealbumin) | 8 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |