Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	February 23, 2009
Last Updated Date	March 26, 2009
Start Date ^†	March 2008
Current Primary Outcome Measures ^† (submitted: February 23, 2009)	Asthma Control Questionnaire [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00850265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: March 26, 2009)	Peak Flow [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ] Asthmatics Symptoms [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ] Side effects [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ] Inhalation technique [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^† (submitted: February 23, 2009)	Peak Flow Asthmatics Symptoms Side effects Inhalation technique [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]

Descriptive Information
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
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
Study Phase
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Condition ^†	Asthma
Intervention ^†	Device: Volumatic spacer
Study Arms / Comparison Groups	Experimental: Extrafine formoterol plus beclomethasone with spacer No Intervention: Extrafine formoterol plus beclomethasone without spacer
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	40
Completion Date	December 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	Spain
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00850265
Responsible Party	Miguel Angel Martínez García, Hospital General de Requena
Secondary IDs ^††
Study Sponsor ^†	Hospital General de Requena
Collaborators ^††
Investigators ^†
Information Provided By	Hospital General de Requena
Verification Date	March 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.