Effect of the Salbutamol on Mechanical Properties of Respiratory System

NCT01521572 | Unknown DMC

• 2 other identifiers: 2927/2011CEP2927/2011HUPE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Airway Obstruction

Keywords

chronic obstructive pulmonary disease,; bronchial reversibility,; bronchodilator,; respiratory impedance,; forced oscillation technique,; plethysmography,; spirometry; Diagnostic Techniques, Respiratory System

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Salbutamol

  twenty minutes

Study Arms (1)

Salbutamol

EXPERIMENTAL

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

Interventions

Salbutamol sulphate DRUG

bronchodilator test, beta2-agonist, short-acting, six hours duration, 400 micrograms.

Also known as: Aerogold, GO/DRUGS/341/L, LOTE: YR1070

Salbutamol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy individuals, smokers and patients with chronic obstructive pulmonary disease.

You may not qualify if:

• healthy subjects: no history of smoking respiratory infection and disease respiratory
• smokers and chronic obstructive pulmonary disease patients: asthma and other respiratory diseases.

Sponsors & Collaborators

• Rio de Janeiro State University: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator

Study Sites (1)

Laboratory biomedical instrumentation - State University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 20550013, Brazil

RECRUITING

Related Links

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

MeSH Terms

Conditions

Smoking; Airway Obstruction; Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Behavior; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Gerusa M Costa, MSc

  State University of Rio de Janeiro

  PRINCIPAL INVESTIGATOR

• Pedro L Melo, PhD

  Laboratory biomedical instrumentation

  STUDY DIRECTOR

Central Study Contacts

Agnaldo J Lopes, PhD

CONTACT

55+(21) 98536162; phel.lop@uol.com.br

Pedro L de Melo, PhD

CONTACT

55+(21) 2334-0705; plopes@uerj.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 30, 2012
• Study Start: June 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 2, 2012

Record last verified: 2012-01

Locations

BR (1)