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Sponsored by: |
Hospital General de Requena |
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Information provided by: | Hospital General de Requena |
ClinicalTrials.gov Identifier: | NCT00850265 |
Combined inhaled treatment with long acting adrenergics and steroids in an unique inhaler plays an important role in the management of non-mild asthma. Some studies have demonstrated that the use of spacers achieve better lung deposition and decrease the number of side effects. Recently a new combined treatment for asthma has been developed (extrafine formoterol plus beclomethasone dipropionate). The small size of the extrafine particles of this new combination get the small airway and theorically improve their positive effect. Some authors have stated that the use of a spacer with extrafine particle could decrease the effectiveness of this treatment due to the adhesion of particles on the walls of the spacer because of the electrostatic characteristics of plastic spacers.
However, there are no clinical or functional studies demonstrating the role of this phenomena in the control of asthmatic patients. The investigators' hypothesis is that the benefit of using spacers with this new treatment is at least equal in magnitude than the loss of efficacy because of the adhesion of particles on the wall of the spacer and then the investigators hypothesized that the use of spacer with extrafine formoterol-beclomethasone do not suppose a decrease in clinical or functional control in stable moderate-severe asthma patients.
Condition | Intervention |
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Asthma |
Device: Volumatic spacer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Rol of Spacer in the Combined Treatment With Extrafine Beclomethasone-Formoterol in Stable Asthma |
Enrollment: | 40 |
Study Start Date: | March 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Spacer: Experimental
Extrafine formoterol plus beclomethasone with spacer
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Device: Volumatic spacer
A spacer is a plastic device to inhaler medication
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No Spacer: No Intervention
Extrafine formoterol plus beclomethasone without spacer
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Hospital General de Requena ( Miguel Angel Martínez García ) |
Study ID Numbers: | FORM-DPB-extrafine |
Study First Received: | February 23, 2009 |
Last Updated: | March 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00850265 History of Changes |
Health Authority: | Spain: Ethics Committee |
Asthma Formoterol Beclomethasone Extrafine formulation |
Spacer Moderate Severe Stable |
Anti-Inflammatory Agents Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Asthma Beclomethasone Glucocorticoids |
Hormones Adrenergic Agonists Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Formoterol Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Beclomethasone Hormones Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases |
Therapeutic Uses Formoterol Immune System Diseases Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |