Effect of the Salbutamol on Mechanical Properties of Respiratory System

Smoking Clinical Trial

Official title:

Effect of the Use of Salbutamol on the Mechanical Properties of the Respiratory System of Healthy Individuals, Smokers and COPD Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01521572
• Other study ID #: 2927/2011
• Secondary ID: CEP2927/2011HUPE
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2012
• Last updated: January 31, 2012
• Start date: June 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2012
• Source: Rio de Janeiro State University
• Contact: Agnaldo J Lopes, PhD
• Phone: 55+(21) 98536162
• Email: phel.lop[@]uol.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Airway Obstruction
• Smoking

Intervention

Drug:
• Salbutamol sulphate
bronchodilator test, beta2-agonist, short-acting, six hours duration, 400 micrograms.

Locations

Country	Name	City	State
Brazil	Laboratory biomedical instrumentation - State University of Rio de Janeiro	Rio de Janeiro

Sponsors (3)

Lead Sponsor	Collaborator
Rio de Janeiro State University	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	two o'clock	No
Secondary	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.	twenty minutes	Yes

External Links

•   http://www.ncbi.nlm.nih.gov/pubmed?term=gerusa%20maritimo%20da%20costa