Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma

This study has been completed.
Sponsor:
Information provided by:
Hospital General de Requena
ClinicalTrials.gov Identifier:
NCT00850265
First received: February 23, 2009
Last updated: March 26, 2009
Last verified: March 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850265

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

No publications provided

Responsible Party: Miguel Angel Martínez García, Hospital General de Requena
ClinicalTrials.gov Identifier: NCT00850265     History of Changes
Other Study ID Numbers: FORM-DPB-extrafine
Study First Received: February 23, 2009
Last Updated: March 26, 2009
Health Authority: Spain: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 21, 2014