Effects of CPAP in Severe Therapy-resistant Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Device: Continuous Positive Airway Pressure (CPAP)

• Registration Number: NCT03215303
• Lead Sponsor: Pontificia Universidade Católica do Rio Grande do Sul

Brief Summary

The purpose of this study is to verify the effects of continuous positive airway pressure (CPAP) on exercise capacity of children and adolescents with severe therapy-resistant asthma (STRA). A randomized, controlled, crossover clinical trial will be conducted. We expect the use of CPAP to increase exercise capacity in children and adolescents with STRA.

Detailed Description

This project aims to verify the effects of continuous positive airway pressure (CPAP) on exercise capacity of children and adolescents with severe asthma therapy-resistant (STRA). A randomized, controlled, crossover clinical trial will be conducted. Children and adolescents between 6 and 18 years old, with a diagnosis of STRA, will be included in the study. Patients wil be recruited in the São Lucas Hospital (HSL) Asthma Outpatient Clinic of the Pontifical Catholic University of Rio Grande do Sul. Patients who accept to participate in the study will perform a medical consultation according to routine outpatient asthma clinic, anthropometric evaluation and pulmonary function tests. Afterwards, they will be randomized into control and intervention groups. Participants in the intervention group will use noninvasive ventilation (NIV) in CPAP mode with 10cmH2O of positive end-expiratory pressure (PEEP), fraction of inspired oxygen (FiO2) of 0.21, for a period of 40 minutes. Participants in the control group will use NIV (CPAP), with a minimum PEEP of 1cmH20 and a FiO2 of 0.21 also for 40 minutes. Afterwards, patients from both groups will perform a maximum cardiopulmonary exercise test (CPET). A sample size of 18 individuals to be included in the study was estimated. The variables studied will be maximal oxygen consumption and the anaerobic threshold (that measures exercise capacity), distance and time (to measure exercise tolerance), peripheral oxygen saturation, peak expiratory flow and the sensation of dyspnea at the end of the CPET.

Study Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Study Start: 2017-07-25
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Individuals with a clinical diagnosis of severe therapy-resistant asthma (STRA), of both sexes, aged between 6 and 18 years, who are under regular follow-up in the asthma outpatient clinic at São Lucas Hospital, PUCRS.

The criteria for the classification of STRA is based on the Global Initiative for Asthma (GINA) guidelines:

• Asthma requiring treatment in steps 4-5 of GINA (≥800 mg/day of budesonide or equivalent, associated with long-acting ß2-adrenergic agonist (LABA);
• Use of continuous oral corticoid or omalizumab, presenting uncontrolled disease;
• Uncontrolled disease characterized by: 1) persistent symptoms or asthma control test (ACT) <20 (> 3 months); 2) acute exacerbations (with intensive care unit admission, at least 2 hospitalizations, or 2 courses of oral corticoid over the last 12 months); Or 3) non-reversible obstruction of pulmonary function, even after corticoid use.

Exclusion Criteria

• Subjects with cognitive/motor limitations or other chronic diseases (neurological diseases, cardiac anomalies, congenital or immunodeficiencies), which may compromise the evaluation of asthma, as well as the procedures proposed by the present study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Continuous Positive Airway Pressure (CPAP)	Continuous Positive Airway Pressure (CPAP)	Participants in the intervention group will use CPAP device, for a period of 40 minutes, with the following parameters: PEEP of 10cmH2O and FiO2 0.21.
CONTROL	Continuous Positive Airway Pressure (CPAP)	Participants in the control group will use CPAP device, for a period of 40 minutes, with the following parameters: PEEP of 1cmH2O and FiO2 0.21.

Primary Outcome Measures

Name	Time	Method
Exercise capacity	Immediately after intervention	Exercise capacity will be assessed by the VO2max, evaluated during a cardiopulmonary exercise test. Gas capture measurement will be performed by an ergospirometric system using a VO2000 (Medical Graphics Corporation, St. Paul, Minnesota-USA) gas analyzer, which provides information on ventilatory variables every 20s.

Secondary Outcome Measures

Name	Time	Method
Peripheral oxygen saturation	Immediately after intervention	Peripheral oxygen saturation will be evaluated at rest, every 60s and at the end of the CPET using a portable pulse oximeter (Nonin®, Minneapolis, USA).
Peak expiratory flow	Immediately after intervention	Peak expiratory flow will be assessed using a peak flow meter immediately after CPET.
Subjective feeling of dyspnea	Immediately after intervention	Subjective feeling of dyspnea will be evaluated using the Modified Borg Scale, which uses a graduation from 0 to 10, at the end of the CPET.
Exercise duration	Immediately after intervention	Exercise tolerance will be assessed by measuring time in the cardiopulmonary exercise test.
Exercise tolerance	Immediately after intervention	Exercise tolerance will be assessed by measuring distance in the cardiopulmonary exercise test.

Trial Locations

Locations (1)

Pontifífia Universidade Católica do Rio Grande do Sul; 🇧🇷 Porto Alegre, RS, Brazil