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Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00850265
Enrollment
40
Registered
2009-02-24
Start date
2008-03-31
Completion date
2008-12-31
Last updated
2009-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Formoterol, Beclomethasone, Extrafine formulation, Spacer, Moderate, Severe, Stable

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.

Interventions

DEVICEVolumatic spacer

A spacer is a plastic device to inhaler medication

Sponsors

Hospital General de Requena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Asthma Control Questionnaireat 3 months

Secondary

MeasureTime frame
Peak Flowat 3 months
Asthmatics Symptomsat 3 months
Side effectsat 3 months
Inhalation techniqueat 3 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026