Effect of the Salbutamol on Mechanical Properties of Respiratory System
This study is currently recruiting participants.
Verified January 2012 by Rio de Janeiro State University
Sponsor:
Rio de Janeiro State University
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
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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:
Drug Information available for:
Albuterol
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Levalbuterol tartrate
U.S. FDA Resources
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:
|
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
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 Smoking Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases Habits Albuterol Bronchodilator Agents Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 22, 2013