Effects of CPAP in Severe Therapy-resistant Asthma (CPAP-STRA)

February 24, 2020 updated by: Marcio Vinicius Fagundes Donadio, Pontificia Universidade Católica do Rio Grande do Sul

Effects of Continuous Positive Airway Pressure (CPAP) on Exercise Capacity of Children and Adolescents With Severe Therapy-resistant Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90619-900
        • Pontifífia Universidade Católica do Rio Grande do Sul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Continuous Positive Airway Pressure (CPAP)
In the first moment, CPAP will be installed, and the researcher will hold a mask in the position in which it is coherent, explaining the method to the patient and allowing their gradual adaptation. Patients will adapt for a few minutes to make sure the mask is consistent with the specifications, so that the patient is comfortable. Participants in the intervention group will start with a PEEP of 1cmH2O that will increase by 2 cmH2O until a PEEP of 10 cmH2O is reached. Therefore, participants in the intervention group will remain with CPAP, PEEP of 10cmH2O, FiO2 0.21, for a period of 40 minutes.
Placebo Comparator: CONTROL
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.
Device: Continuous Positive Airway Pressure (CPAP)
In the first moment, CPAP will be installed, and the researcher will hold a mask in the position in which it is coherent, explaining the method to the patient and allowing their gradual adaptation. Patients will adapt for a few minutes to make sure the mask is consistent with the specifications, so that the patient is comfortable. Participants in the intervention group will start with a PEEP of 1cmH2O that will increase by 2 cmH2O until a PEEP of 10 cmH2O is reached. Therefore, participants in the intervention group will remain with CPAP, PEEP of 10cmH2O, FiO2 0.21, for a period of 40 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise capacity
Time Frame: 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.
Immediately after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise tolerance
Time Frame: Immediately after intervention
Exercise tolerance will be assessed by measuring distance in the cardiopulmonary exercise test.
Immediately after intervention
Exercise duration
Time Frame: Immediately after intervention
Exercise tolerance will be assessed by measuring time in the cardiopulmonary exercise test.
Immediately after intervention
Peripheral oxygen saturation
Time Frame: 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).
Immediately after intervention
Peak expiratory flow
Time Frame: Immediately after intervention
Peak expiratory flow will be assessed using a peak flow meter immediately after CPET.
Immediately after intervention
Subjective feeling of dyspnea
Time Frame: 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.
Immediately after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Investigators

  • Principal Investigator: Marcio VF Donadio, PHD, Pontificia Universidade Católica do Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2017

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

July 7, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 12, 2017

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on Continuous Positive Airway Pressure (CPAP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe