NCT00850265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Mar 2008

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
Last Updated

March 27, 2009

Status Verified

March 1, 2009

Enrollment Period

9 months

First QC Date

February 23, 2009

Last Update Submit

March 26, 2009

Conditions

Asthma

Keywords

AsthmaFormoterolBeclomethasoneExtrafine formulationSpacerModerateSevereStable

Outcome Measures

Primary Outcomes (1)

  • Asthma Control Questionnaire

    at 3 months

Secondary Outcomes (4)

  • Peak Flow

    at 3 months

  • Asthmatics Symptoms

    at 3 months

  • Side effects

    at 3 months

  • Inhalation technique

    at 3 months

Study Arms (2)

Spacer

EXPERIMENTAL

Extrafine formoterol plus beclomethasone with spacer

Device: Volumatic spacer

No Spacer

NO INTERVENTION

Extrafine formoterol plus beclomethasone without spacer

Interventions

Volumatic spacerDEVICE

A spacer is a plastic device to inhaler medication

Spacer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate-severe asthma
  • Stable asthma
  • years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de Requena

Requena-Valencia, Valencia, 46340, Spain

Location

MeSH Terms

Conditions

AsthmaLymphoma, Follicular

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 24, 2009

Study Start

March 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 27, 2009

Record last verified: 2009-03

Locations

ES(1)