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Effects of Noninvasive Ventilation Compared to Salbutamol

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430505


Locations
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Brazil
Nove de Julho University
São Paulo, Brazil, 01.504-001
Sponsors and Collaborators
University of Nove de Julho
Investigators
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Study Chair: Dirceu Costa, Doctor Nove de Julho University

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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    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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