Magnesium Loading in Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT00500864|
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : July 2, 2008
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Drug: Magnesium Sulfate 2 grams||Phase 1 Phase 2|
Patients are required to have a diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease criteria.
This is a randomized, double-blind, placebo-controlled, cross-over study. Twenty five patients are going to be included. They are going to come to the laboratory to receive IV placebo or IV Mg sulfate at two distinct occasions about 48 hours apart. Half of the patients are going to receive Mg first and Placebo at the second day, while the other half are going to receive the treatments in an inverse order. Tests are going to be performed before and about 40 minutes after the IV infusions. Tests to be performed are: spirometry, arterial blood gases, Mg plasma level measurements, and a maximal exercise test protocol in cycloergometer.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effects of Acute Intravenous Magnesium Loading on Pulmonary Function Parameters and Maximal Exercise Capacity of Patients With Chronic Obstructive Pulmonary Disease in Stable Clinical Conditions.|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
- Measurements of forced vital capacity (FVC), forced expiratory volume (FEV1), functional residual capacity (FRC),maximal respiratory pressures,maximal oxygen consumption and maximal work load. [ Time Frame: Immediatly after the end of IV infusion ]
- Arterial blood gases at rest, heart rate and mean arterial blood pressure. Degree of desaturation during maximal exercise. [ Time Frame: Immediatly after the end of IV infusion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500864
|Hospital das Clínicas de Ribeirão Preto|
|Ribeirão Preto, SP, Brazil, 14048-900|
|Principal Investigator:||José B Martinez, MD, PhD||University of Sao Paulo|