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Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Volumatic spacer
Sponsored by
Hospital General de Requena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Formoterol, Beclomethasone, Extrafine formulation, Spacer, Moderate, Severe, Stable

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Hospital General de Requena

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Spacer

No Spacer

Arm Description

Extrafine formoterol plus beclomethasone with spacer

Extrafine formoterol plus beclomethasone without spacer

Outcomes

Primary Outcome Measures

Asthma Control Questionnaire

Secondary Outcome Measures

Peak Flow
Asthmatics Symptoms
Side effects
Inhalation technique

Full Information

First Posted
February 23, 2009
Last Updated
March 26, 2009
Sponsor
Hospital General de Requena
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1. Study Identification

Unique Protocol Identification Number
NCT00850265
Brief Title
Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma
Official Title
Rol of Spacer in the Combined Treatment With Extrafine Beclomethasone-Formoterol in Stable Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital General de Requena

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Formoterol, Beclomethasone, Extrafine formulation, Spacer, Moderate, Severe, Stable

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spacer
Arm Type
Experimental
Arm Description
Extrafine formoterol plus beclomethasone with spacer
Arm Title
No Spacer
Arm Type
No Intervention
Arm Description
Extrafine formoterol plus beclomethasone without spacer
Intervention Type
Device
Intervention Name(s)
Volumatic spacer
Intervention Description
A spacer is a plastic device to inhaler medication
Primary Outcome Measure Information:
Title
Asthma Control Questionnaire
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Peak Flow
Time Frame
at 3 months
Title
Asthmatics Symptoms
Time Frame
at 3 months
Title
Side effects
Time Frame
at 3 months
Title
Inhalation technique
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital General de Requena
City
Requena-Valencia
State/Province
Valencia
ZIP/Postal Code
46340
Country
Spain

12. IPD Sharing Statement

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Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma

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