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Effect of the Salbutamol on Mechanical Properties of Respiratory System

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Gerusa Maritimo da Costa, Rio de Janeiro State University.
Recruitment status was:  Recruiting
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Gerusa Maritimo da Costa, Rio de Janeiro State University Identifier:
First received: January 26, 2012
Last updated: January 31, 2012
Last verified: January 2012
The aim of this study is to assess the bronchodilator response of salbutamol on respiratory mechanics of healthy individuals, smokers and COPD with varying degrees of airway obstruction.

Condition Intervention
Airway Obstruction
Drug: Salbutamol sulphate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of the Use of Salbutamol on the Mechanical Properties of the Respiratory System of Healthy Individuals, Smokers and COPD Patients

Resource links provided by NLM:

Further study details as provided by Gerusa Maritimo da Costa, Rio de Janeiro State University:

Primary Outcome Measures:
  • Respiratory function test [ Time Frame: two o'clock ]
    Evaluation of pulmonary mechanics before and after salbutamol (short-acting bronchodilator) in healthy individuals, smokers and chronic obstructive pulmonary disease in stages: mild, moderate, severe and very severe according to GOLD criteria.

Secondary Outcome Measures:
  • Salbutamol [ Time Frame: twenty minutes ]
    In the bronchodilator test will be used 400 micrograms of beta2-agonist short-acting. They will be asked to exhale slowly until they can no longer expel more air from the lungs. To place the inhaler with a spacer between the lips, pressing them well, but no bite. Shortly thereafter start to breathe through the mouth and will be released a jet of 100 micrograms of the bronchodilator. Then they will hold their breath for 10 seconds. 3 puffs are made with 1 minute interval between each application.

Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Salbutamol
Short-acting bronchodilator for use in humans released by the Ministry of Health, widely used worldwide for the treatment of chronic obstructive pulmonary disease.
Drug: Salbutamol sulphate
bronchodilator test, beta2-agonist, short-acting, six hours duration, 400 micrograms.
Other Names:
  • Aerogold
  • GO/DRUGS/341/L
  • LOTE: YR1070

Detailed Description:
Clinical evaluation will be conducted and anthropometric measurements, then the pulmonary function tests: forced oscillation technique (FOT), whole body plethysmography, spirometry and-administration of salbutamol aerosol for assessment of bronchodilator response. After 20 minutes, the individual will be evaluated again following the same sequence.

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy individuals, smokers and patients with chronic obstructive pulmonary disease.

Exclusion Criteria:

  • healthy subjects: no history of smoking respiratory infection and disease respiratory
  • smokers and chronic obstructive pulmonary disease patients: asthma and other respiratory diseases.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01521572

Contact: Agnaldo J Lopes, PhD 55+(21) 98536162
Contact: Pedro L de Melo, PhD 55+(21) 2334-0705

Laboratory biomedical instrumentation - State University of Rio de Janeiro Recruiting
Rio de Janeiro, Brazil, 20550013
Principal Investigator: Gerusa M Costa, MSc         
Sponsors and Collaborators
Rio de Janeiro State University
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Principal Investigator: Gerusa M Costa, MSc State University of Rio de Janeiro
Study Director: Pedro L Melo, PhD Laboratory biomedical instrumentation
  More Information

Additional Information:
Responsible Party: Gerusa Maritimo da Costa, Master, Rio de Janeiro State University Identifier: NCT01521572     History of Changes
Other Study ID Numbers: 2927/2011
CEP2927/2011HUPE ( Other Identifier: Ethics Committee in Research of HUPE )
Study First Received: January 26, 2012
Last Updated: January 31, 2012

Keywords provided by Gerusa Maritimo da Costa, Rio de Janeiro State University:
chronic obstructive pulmonary disease,
bronchial reversibility,
respiratory impedance,
forced oscillation technique,
Diagnostic Techniques, Respiratory System

Additional relevant MeSH terms:
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017