Effect of the Salbutamol on Mechanical Properties of Respiratory System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Rio de Janeiro State University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01521572
First received: January 26, 2012
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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
Smoking
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 Rio de Janeiro State University:

Primary Outcome Measures:
  • Respiratory function test [ Time Frame: two o'clock ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT01521572

Contacts
Contact: Agnaldo J Lopes, PhD 55+(21) 98536162 phel.lop@uol.com.br
Contact: Pedro L de Melo, PhD 55+(21) 2334-0705 plopes@uerj.br

Locations
Brazil
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)
Investigators
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:
No publications provided

Responsible Party: Gerusa Maritimo da Costa, Master, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT01521572     History of Changes
Other Study ID Numbers: 2927/2011, CEP2927/2011HUPE
Study First Received: January 26, 2012
Last Updated: January 31, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Rio de Janeiro State University:
chronic obstructive pulmonary disease,
bronchial reversibility,
bronchodilator,
respiratory impedance,
forced oscillation technique,
plethysmography,
spirometry
Diagnostic Techniques, Respiratory System

Additional relevant MeSH terms:
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Albuterol
Bronchodilator Agents
Respiratory System Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014