Effects of CPAP in Severe Therapy-resistant Asthma

NCT03215303 | Completed

• 1 other identifier: CPAP
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Continuous positive airway pressure; Oxygen consumption

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  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 Outcomes (5)

• Exercise tolerance

  Immediately after intervention

• Exercise duration

  Immediately after intervention

• Peripheral oxygen saturation

  Immediately after intervention

• Peak expiratory flow

  Immediately after intervention

• Subjective feeling of dyspnea

  Immediately after intervention

Study Arms (2)

Continuous Positive Airway Pressure (CPAP)

EXPERIMENTAL

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)

CONTROL

PLACEBO COMPARATOR

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)

Interventions

Continuous Positive Airway Pressure (CPAP) DEVICE

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.

CONTROL; Continuous Positive Airway Pressure (CPAP)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead

Study Sites (1)

Pontifífia Universidade Católica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Location

Related Publications (15)

• Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald JM, Gibson P, Ohta K, O'Byrne P, Pedersen SE, Pizzichini E, Sullivan SD, Wenzel SE, Zar HJ. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008 Jan;31(1):143-78. doi: 10.1183/09031936.00138707.

  PMID: 18166595 BACKGROUND

• Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet. 1998 Apr 25;351(9111):1225-32.

  PMID: 9643741 BACKGROUND

• McDonald VM, Vertigan AE, Gibson PG. How to set up a severe asthma service. Respirology. 2011 Aug;16(6):900-11. doi: 10.1111/j.1440-1843.2011.02012.x.

  PMID: 21692918 BACKGROUND

• Jang AS, Lee JH, Park SW, Shin MY, Kim DJ, Park CS. Severe airway hyperresponsiveness in school-aged boys with a high body mass index. Korean J Intern Med. 2006 Mar;21(1):10-4. doi: 10.3904/kjim.2006.21.1.10.

  PMID: 16646558 BACKGROUND

• O'Donnell DE, Sanii R, Giesbrecht G, Younes M. Effect of continuous positive airway pressure on respiratory sensation in patients with chronic obstructive pulmonary disease during submaximal exercise. Am Rev Respir Dis. 1988 Nov;138(5):1185-91. doi: 10.1164/ajrccm/138.5.1185.

  PMID: 3059891 BACKGROUND

• Wang CH, Lin HC, Huang TJ, Yang CT, Yu CT, Kuo HP. Differential effects of nasal continuous positive airway pressure on reversible or fixed upper and lower airway obstruction. Eur Respir J. 1996 May;9(5):952-9. doi: 10.1183/09031936.96.09050952.

  PMID: 8793457 BACKGROUND

• Busk M, Busk N, Puntenney P, Hutchins J, Yu Z, Gunst SJ, Tepper RS. Use of continuous positive airway pressure reduces airway reactivity in adults with asthma. Eur Respir J. 2013 Feb;41(2):317-22. doi: 10.1183/09031936.00059712. Epub 2012 Jul 26.

  PMID: 22835615 BACKGROUND

• Pianosi PT, Davis HS. Determinants of physical fitness in children with asthma. Pediatrics. 2004 Mar;113(3 Pt 1):e225-9. doi: 10.1542/peds.113.3.e225.

  PMID: 14993581 BACKGROUND

• Ferrazza AM, Martolini D, Valli G, Palange P. Cardiopulmonary exercise testing in the functional and prognostic evaluation of patients with pulmonary diseases. Respiration. 2009;77(1):3-17. doi: 10.1159/000186694. Epub 2009 Jan 14.

  PMID: 19145106 BACKGROUND

• Hallstrand TS, Bates PW, Schoene RB. Aerobic conditioning in mild asthma decreases the hyperpnea of exercise and improves exercise and ventilatory capacity. Chest. 2000 Nov;118(5):1460-9. doi: 10.1378/chest.118.5.1460.

  PMID: 11083702 BACKGROUND

• Chatkin M, Menezes AM, Albernaz E, Victora CG, Barros FC. [Asthmatic children's risk factors for emergency room visits, Brazil]. Rev Saude Publica. 2000 Oct;34(5):491-8. doi: 10.1590/s0034-89102000000500009. Portuguese.

  PMID: 11105113 BACKGROUND

• Schuh C, Fritscher LG, Chapman KR, Fritscher CC. The prevalence of asthma and atopy in schoolchildren from Porto Alegre, Brazil, has plateaued. Respir Med. 2015 Mar;109(3):308-11. doi: 10.1016/j.rmed.2015.01.014. Epub 2015 Jan 31.

  PMID: 25683031 BACKGROUND

• Barbosa e Silva O, Saraiva LC, Sobral Filho DC. Treadmill stress test in children and adolescents: higher tolerance on exertion with ramp protocol. Arq Bras Cardiol. 2007 Dec;89(6):391-7. English, Portuguese.

  PMID: 18317622 BACKGROUND

• Beaver WL, Wasserman K, Whipp BJ. A new method for detecting anaerobic threshold by gas exchange. J Appl Physiol (1985). 1986 Jun;60(6):2020-7. doi: 10.1152/jappl.1986.60.6.2020.

  PMID: 3087938 BACKGROUND

• Santuz P, Baraldi E, Filippone M, Zacchello F. Exercise performance in children with asthma: is it different from that of healthy controls? Eur Respir J. 1997 Jun;10(6):1254-60. doi: 10.1183/09031936.97.10061254.

  PMID: 9192925 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Marcio VF Donadio, PHD

  Pontificia Universidade Católica do Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 12, 2017
• Study Start: July 25, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)