Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma
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Purpose
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 |
|---|---|
|
Asthma |
Device: Volumatic spacer |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Rol of Spacer in the Combined Treatment With Extrafine Beclomethasone-Formoterol in Stable Asthma |
- Asthma Control Questionnaire [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
- Peak Flow [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
- Asthmatics Symptoms [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
- Side effects [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
- Inhalation technique [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Experimental: Spacer
Extrafine formoterol plus beclomethasone with spacer
|
Device: Volumatic spacer
A spacer is a plastic device to inhaler medication
|
|
No Intervention: No Spacer
Extrafine formoterol plus beclomethasone without spacer
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Moderate-severe asthma
- Stable asthma
- 18-75 years old
Exclusion Criteria:
- Exacerbation of asthma
- Instability with the study treatment
- Other cardiopulmonary disease
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Miguel Angel Martínez García, Hospital General de Requena |
| ClinicalTrials.gov Identifier: | NCT00850265 History of Changes |
| Other Study ID Numbers: | FORM-DPB-extrafine |
| Study First Received: | February 23, 2009 |
| Last Updated: | March 26, 2009 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Hospital General de Requena:
|
Asthma Formoterol Beclomethasone Extrafine formulation |
Spacer Moderate Severe Stable |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Beclomethasone Formoterol Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013