Effects of Noninvasive Ventilation Compared to Salbutamol

• ClinicalTrials.gov Identifier: NCT03430505
• Recruitment Status: Completed
• First Posted: February 13, 2018
• Last Update Posted: July 22, 2019
• Sponsor: University of Nove de Julho
• Information provided by (Responsible Party): Evelim Leal de Freitas Dantas Gomes, PT, University of Nove de Julho

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Device: Bilevel; Drug: Albuterol	Not Applicable

  Show Detailed Description

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Noninvasive Ventilation Compared to Salbutamol in Respiratory Mechanics and Lung Function of Asthmatics After Bronchoprovocation: Randomized Cross-over Trial
• Actual Study Start Date: June 10, 2017
• Actual Primary Completion Date: July 11, 2018
• Actual Study Completion Date: December 20, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Bilevel; Bilevel 10 minutes after bronchoprovocation with saline solution 4.5%. IPAP 12 and EPAP 8	Device: Bilevel; 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.
Active Comparator: Albuterol; 400micrograms after bronchoprovocation with saline solution 4.5%.	Drug: Albuterol; 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.

Outcome Measures

Primary Outcome Measures :

1. FEV1 [ Time Frame: Change from baseline FEV1 at 1 hour ]
   Spirometry
2. Expiratory time [ Time Frame: Change from baseline expiratory time at 1 hour ]
   Optoeletronic Plethismography
3. Inspiratory Capacity [ Time Frame: Change from baseline IC at 1 hour ]
   Spirometry

Secondary Outcome Measures :

1. Minute Volume [ Time Frame: Change from baseline minute volume at 1 hour ]
   Optoeletronic Plethismography

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 29 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

INCLUSION CRITERIA:

• 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

EXCLUSION CRITERIA:

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

Contacts and Locations

Locations

Brazil

Nove de Julho University

São Paulo, Brazil, 01.504-001

Sponsors and Collaborators

University of Nove de Julho

Investigators

• Study Chair: Dirceu Costa, Doctor; Nove de Julho University

More Information

• Responsible Party: Evelim Leal de Freitas Dantas Gomes, PT, Clinical Professor, University of Nove de Julho
• ClinicalTrials.gov Identifier: NCT03430505 History of Changes
• Other Study ID Numbers: OEP Asthma
• First Posted: February 13, 2018
• Last Update Posted: July 22, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Evelim Leal de Freitas Dantas Gomes, PT, University of Nove de Julho:

Asthma, noninvasive ventilation

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Albuterol; Pharmaceutical Solutions; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Tocolytic Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action