Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma

NCT ID: NCT00850265

Last Updated: 2009-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-12-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Spacer

Extrafine formoterol plus beclomethasone with spacer

Group Type: EXPERIMENTAL

Volumatic spacer

Intervention Type: DEVICE

A spacer is a plastic device to inhaler medication

No Spacer

Extrafine formoterol plus beclomethasone without spacer

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Volumatic spacer

A spacer is a plastic device to inhaler medication

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General de Requena

OTHER

Sponsor Role: lead

Responsible Party

Hospital General de Requena

Locations

Hospital General de Requena

Requena-Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

FORM-DPB-extrafine

Identifier Type: -

Identifier Source: org_study_id