Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850265
• Other study ID #: FORM-DPB-extrafine
• Status: Completed
• Phase: N/A
• First received: February 23, 2009
• Last updated: March 26, 2009
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: Hospital General de Requena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Volumatic spacer
A spacer is a plastic device to inhaler medication

Locations

Country	Name	City	State
Spain	Hospital General de Requena	Requena-Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Requena

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Questionnaire		at 3 months	Yes
Secondary	Peak Flow		at 3 months	Yes
Secondary	Asthmatics Symptoms		at 3 months	Yes
Secondary	Side effects		at 3 months	Yes
Secondary	Inhalation technique		at 3 months	Yes