Back to resultsEffect of the Salbutamol on Mechanical Properties of Respiratory System
Primary Purpose
Smoking, Airway Obstruction
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Salbutamol sulphate
Sponsored by
About this trial
This is an interventional basic science trial for Smoking focused on measuring chronic obstructive pulmonary disease,, bronchial reversibility,, bronchodilator,, respiratory impedance,, forced oscillation technique,, plethysmography,, spirometry, Diagnostic Techniques, Respiratory System
Eligibility 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.
Sites / Locations
- Laboratory biomedical instrumentation - State University of Rio de JaneiroRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Salbutamol
Arm Description
Short-acting bronchodilator for use in humans released by the Ministry of Health, widely used worldwide for the treatment of chronic obstructive pulmonary disease.
Outcomes
Primary Outcome Measures
Respiratory function test
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
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.
Full Information
NCT ID
NCT01521572
First Posted
January 26, 2012
Last Updated
January 31, 2012
Sponsor
Rio de Janeiro State University
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
1. Study Identification
Unique Protocol Identification Number
NCT01521572
Brief Title
Effect of the Salbutamol on Mechanical Properties of Respiratory System
Official Title
Effect of the Use of Salbutamol on the Mechanical Properties of the Respiratory System of Healthy Individuals, Smokers and COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rio de Janeiro State University
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Airway Obstruction
Keywords
chronic obstructive pulmonary disease,, bronchial reversibility,, bronchodilator,, respiratory impedance,, forced oscillation technique,, plethysmography,, spirometry, Diagnostic Techniques, Respiratory System
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Salbutamol
Arm Type
Experimental
Arm Description
Short-acting bronchodilator for use in humans released by the Ministry of Health, widely used worldwide for the treatment of chronic obstructive pulmonary disease.
Intervention Type
Drug
Intervention Name(s)
Salbutamol sulphate
Other Intervention Name(s)
Aerogold, GO/DRUGS/341/L, LOTE: YR1070
Intervention Description
bronchodilator test, beta2-agonist, short-acting, six hours duration, 400 micrograms.
Primary Outcome Measure Information:
Title
Respiratory function test
Description
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.
Time Frame
two o'clock
Secondary Outcome Measure Information:
Title
Salbutamol
Description
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.
Time Frame
twenty minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnaldo J Lopes, PhD
Phone
55+(21) 98536162
Email
phel.lop@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro L de Melo, PhD
Phone
55+(21) 2334-0705
Email
plopes@uerj.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerusa M Costa, MSc
Organizational Affiliation
State University of Rio de Janeiro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedro L Melo, PhD
Organizational Affiliation
Laboratory biomedical instrumentation
Official's Role
Study Director
Facility Information:
Facility Name
Laboratory biomedical instrumentation - State University of Rio de Janeiro
City
Rio de Janeiro
ZIP/Postal Code
20550013
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerusa M Costa, MSc
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov
Description
http://www.ncbi.nlm.nih.gov/pubmed?term=gerusa%20maritimo%20da%20costa
Learn more about this trial
Effect of the Salbutamol on Mechanical Properties of Respiratory System
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