Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Device: Volumatic spacer

• Registration Number: NCT00850265
• Lead Sponsor: Hospital General de Requena

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-23
• Study First Posted: 2009-02-24
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-26
• Last Update Posted: 2009-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Moderate-severe asthma
• Stable asthma
• 18-75 years old

Exclusion Criteria

• Exacerbation of asthma
• Instability with the study treatment
• Other cardiopulmonary disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spacer	Volumatic spacer	Extrafine formoterol plus beclomethasone with spacer

Primary Outcome Measures

Name	Time	Method
Asthma Control Questionnaire	at 3 months

Secondary Outcome Measures

Name	Time	Method
Peak Flow	at 3 months
Asthmatics Symptoms	at 3 months
Side effects	at 3 months
Inhalation technique	at 3 months

Trial Locations

Locations (1)

Hospital General de Requena; 🇪🇸 Requena-Valencia, Valencia, Spain