Effects of Noninvasive Ventilation Compared to Salbutamol

NCT03430505 | Completed

• 1 other identifier: OEP Asthma
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a chronic inflammatory disease characterized by recurrent and reversible episodes of airway obstruction. Drug treatment usually includes inhaled corticosteroids and bronchial dilators, which often do not have adequate adherence. These acute episodes of bronchoconstriction can most often occur with hyperinflation and for decades the mechanisms that lead to hyperinflation have been studied, as well as increasingly modern ways of evaluating and treating these mechanisms. Noninvasive ventilation is increasingly occupying its space as a non-pharmacological resource in the treatment of asthma, initially as an adjunct in an attempt to help medication have its effect reached in the crisis, but this feature has been showing signs of having an even greater action which can even collaborate in reversing the crisis by not only giving time for pharmacological action. Recognizing these potential effects of this widely used resource and understanding its action on lung function and the reversal of exacerbation is part of this scientific process.

Conditions

Asthma

Keywords

Asthma, noninvasive ventilation

Outcome Measures

Primary Outcomes (3)

• FEV1

  Spirometry

  Change from baseline FEV1 at 1 hour

• Expiratory time

  Optoeletronic Plethismography

  Change from baseline expiratory time at 1 hour

• Inspiratory Capacity

  Spirometry

  Change from baseline IC at 1 hour

Secondary Outcomes (1)

• Minute Volume

  Change from baseline minute volume at 1 hour

Study Arms (2)

Bilevel

ACTIVE COMPARATOR

Bilevel 10 minutes after bronchoprovocation with saline solution 4.5%. IPAP 12 and EPAP 8

Device: Bilevel

Albuterol

ACTIVE COMPARATOR

400micrograms after bronchoprovocation with saline solution 4.5%.

Drug: Albuterol

Interventions

Bilevel DEVICE

Basal respiratory mechanics in spontaneous breathing will be analyzed by optoeletronic plethismography (OEP), followed by bronchial provocation with hypertonic saline solution 4.5%, another 45-second OEP uptake, IPAP 12 and EPAP 8 bilevel applied for 10 minutes, and a new uptake. All abstractions are preceded by a forced and slow spirometry maneuver. The entire procedure takes 1 hour.

Bilevel

Albuterol DRUG

Basal respiratory mechanics in spontaneous breathing will be analyzed by optoeletronic plethismography (OEP), followed by bronchial provocation with hypertonic saline solution 4.5%, another 45-second OEP uptake, 400 micrograms inhaled Albuterol, and a new uptake. All abstractions are preceded by a forced and slow spirometry maneuver. The entire procedure takes 1 hour.

Albuterol

Eligibility Criteria

• Age: 12 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12 to 29 years
• Both sexes
• Diagnosis of asthma according to GINA
• Without deterioration in the last 30 days
• No history of respiratory infection in the last 2 months
• Comply with consent form

You may not qualify if:

• Use bronchodilator under 12 hours
• No understanding of the tests
• Heart condition
• Intolerance the proposed activities
• Don't have bronchodilator prescribed by doctor

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, 01.504-001, Brazil

Location

MeSH Terms

Conditions

Asthma

Interventions

Continuous Positive Airway Pressure; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Dirceu Costa, Doctor

  Nove de Julho University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 13, 2018
• Study Start: June 10, 2017
• Primary Completion: July 11, 2018
• Study Completion: December 20, 2018
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)