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OpenTrials
Completed

NCT Number: NCT00850265

Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Volumatic spacer

Device

A spacer is a plastic device to inhaler medication

Primary outcomes

  1. Asthma Control Questionnaire

    Time frame: at 3 months

Secondary outcomes

  1. Peak Flow

    Time frame: at 3 months

  2. Asthmatics Symptoms

    Time frame: at 3 months

  3. Side effects

    Time frame: at 3 months

  4. Inhalation technique

    Time frame: at 3 months

Sponsors and collaborators

Lead sponsor

Hospital General de Requena

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 24, 2009
Registry last updated
Mar 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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