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

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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Bilevel
Bilevel 10 minutes after bronchoprovocation with saline solution 4.5%. IPAP 12 and EPAP 8
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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%.
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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. |
- FEV1 [ Time Frame: Change from baseline FEV1 at 1 hour ]Spirometry
- Expiratory time [ Time Frame: Change from baseline expiratory time at 1 hour ]Optoeletronic Plethismography
- Inspiratory Capacity [ Time Frame: Change from baseline IC at 1 hour ]Spirometry
- Minute Volume [ Time Frame: Change from baseline minute volume at 1 hour ]Optoeletronic Plethismography

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

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
Brazil | |
Nove de Julho University | |
São Paulo, Brazil, 01.504-001 |
Study Chair: | Dirceu Costa, Doctor | Nove de Julho University |
Responsible Party: | Evelim Leal de Freitas Dantas Gomes, PT, Clinical Professor, University of Nove de Julho |
ClinicalTrials.gov Identifier: | NCT03430505 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Asthma, noninvasive ventilation |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol 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 |