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Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00850265
First Posted: February 24, 2009
Last Update Posted: March 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital General de Requena
  Purpose
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.

Condition Intervention
Asthma Device: Volumatic spacer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Rol of Spacer in the Combined Treatment With Extrafine Beclomethasone-Formoterol in Stable Asthma

Resource links provided by NLM:


Further study details as provided by Hospital General de Requena:

Primary Outcome Measures:
  • Asthma Control Questionnaire [ Time Frame: at 3 months ]

Secondary Outcome Measures:
  • Peak Flow [ Time Frame: at 3 months ]
  • Asthmatics Symptoms [ Time Frame: at 3 months ]
  • Side effects [ Time Frame: at 3 months ]
  • Inhalation technique [ Time Frame: at 3 months ]

Enrollment: 40
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spacer
Extrafine formoterol plus beclomethasone with spacer
Device: Volumatic spacer
A spacer is a plastic device to inhaler medication
No Intervention: No Spacer
Extrafine formoterol plus beclomethasone without spacer

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850265


Locations
Spain
Hospital General de Requena
Requena-Valencia, Valencia, Spain, 46340
Sponsors and Collaborators
Hospital General de Requena
  More Information

Responsible Party: Miguel Angel Martínez García, Hospital General de Requena
ClinicalTrials.gov Identifier: NCT00850265     History of Changes
Other Study ID Numbers: FORM-DPB-extrafine
First Submitted: February 23, 2009
First Posted: February 24, 2009
Last Update Posted: March 27, 2009
Last Verified: March 2009

Keywords provided by Hospital General de Requena:
Asthma
Formoterol
Beclomethasone
Extrafine formulation
Spacer
Moderate
Severe
Stable

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol Fumarate
Beclomethasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists