Effect of the Salbutamol on Mechanical Properties of Respiratory System

Not Applicable

• Conditions: Smoking; Airway Obstruction
• Interventions: Drug: Salbutamol sulphate

• Registration Number: NCT01521572
• Lead Sponsor: Rio de Janeiro State University

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.

Study Timeline

• Study Start: 2011-06
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-01-30
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-02
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Salbutamol	Salbutamol sulphate	Short-acting bronchodilator for use in humans released by the Ministry of Health, widely used worldwide for the treatment of chronic obstructive pulmonary disease.

Primary Outcome Measures

Name	Time	Method
Respiratory function test	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

Name	Time	Method
Salbutamol	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.

Trial Locations

Locations (1)

Laboratory biomedical instrumentation - State University of Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil