Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma

Study Overview
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Brief Summary
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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.

Official Title
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Rol of Spacer in the Combined Treatment With Extrafine Beclomethasone-Formoterol in Stable Asthma

Conditions
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Asthma

Intervention / Treatment
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* Device: Volumatic spacer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate-severe asthma Stable asthma 18-75 years old Exclusion Criteria: Exacerbation of asthma Instability with the study treatment Other cardiopulmonary disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spacer<br>Extrafine formoterol plus beclomethasone with spacer | Device: Volumatic spacer<br>* A spacer is a plastic device to inhaler medication<br>|
| No Intervention: No Spacer<br>Extrafine formoterol plus beclomethasone without spacer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire |  | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Flow |  | at 3 months | 
| Asthmatics Symptoms |  | at 3 months | 
| Side effects |  | at 3 months | 
| Inhalation technique |  | at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe, Asthma, Formoterol, Beclomethasone, Extrafine formulation, Spacer, Moderate, Stable