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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03215303
Recruitment Status : Completed
First Posted : July 12, 2017
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Marcio Vinicius Fagundes Donadio, 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.

Condition or disease Intervention/treatment Phase
Asthma Device: Continuous Positive Airway Pressure (CPAP) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patients will be randomized, through a sealed envelope, to initially compose the intervention group or the control group. The sequential order of randomization will be kept confidential with a single investigator, so that the other professionals involved and responsible for data collection will be blinded throughout the study period. Individuals who initially composed the intervention group will then perform, in a second moment, the procedures of the control group.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The randomization process will be kept confidential with a single investigator, not involved in data collection or recruitment, so that all other investigators involved will be blinded to the experimental groups throughout the study period.
Primary Purpose: Treatment
Official Title: Effects of Continuous Positive Airway Pressure (CPAP) on Exercise Capacity of Children and Adolescents With Severe Therapy-resistant Asthma
Actual Study Start Date : July 25, 2017
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Exercise tolerance [ Time Frame: Immediately after intervention ]
    Exercise tolerance will be assessed by measuring distance in the cardiopulmonary exercise test.

  2. Exercise duration [ Time Frame: Immediately after intervention ]
    Exercise tolerance will be assessed by measuring time in the cardiopulmonary exercise test.

  3. 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).

  4. Peak expiratory flow [ Time Frame: Immediately after intervention ]
    Peak expiratory flow will be assessed using a peak flow meter immediately after CPET.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


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): NCT03215303


Locations
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Brazil
Pontifífia Universidade Católica do Rio Grande do Sul
Porto Alegre, RS, Brazil, 90619-900
Sponsors and Collaborators
Pontificia Universidade Católica do Rio Grande do Sul
Investigators
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Principal Investigator: Marcio VF Donadio, PHD Pontificia Universidade Católica do Rio Grande do Sul
Publications:

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Responsible Party: Marcio Vinicius Fagundes Donadio, Professor, Pontificia Universidade Católica do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03215303    
Other Study ID Numbers: CPAP
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
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 Marcio Vinicius Fagundes Donadio, Pontificia Universidade Católica do Rio Grande do Sul:
Asthma
Continuous positive airway pressure
Oxygen consumption
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