Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
physiotherapy techniques
hypertonic saline 3%
saline + physiotherapy maneuvers
Sponsored by

About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Asthmathic children used inhaled corticosteroids not associated with long-acting beta2-agonist.
Exclusion Criteria:
- Asthmathic children to diagnose with other chronic pulmonary pathologies (cystic fibrosis, ciliary dyskinesia, bronchiolitis obliterans, and bronchopulmonary dysplasia) before study, no significant pulmonary pathologies, incapacity to realize pulmonary function and insufficient sample.
Sites / Locations
- Children's Institute of the Clinical Hospital of University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
physiotherapists maneuvers
hypertonic saline 3%
saline + physiotherapy maneuvers
Arm Description
physiotherapy techniques
four nebulizations with 3% hypertonic saline.
1 nebulizations + physiotherapy techniques
Outcomes
Primary Outcome Measures
Sputum induction by physiotherapists maneuvers
children were seated in a position where the thorax was inclined forwards by 45°, they were instructed to perform calm and long exhalations by oscillating positive expiratory pressure (OPEP) during nonstop 5 minutes holding a Flutter® (Scandipharm, Birmingham, AL, EUA). After that, children were positioned in supine zero degree and underwent for more five minutes to a forced exhalation with the open mouth/glottis (huffing) associated to acceleration by forced expiratory technique (FET), performed by the therapist by positioning a hand on xiphoid process and the other in the manubrium sternum.
Secondary Outcome Measures
Sputum induction by hypertonic saline 3%
children received until four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer (Ultraneb 99; DeVilbiss, Somerset, PA) each challenge was monitored with PEF between nebulizations.
Full Information
NCT ID
NCT03136042
First Posted
April 27, 2017
Last Updated
April 15, 2019
Sponsor
University of Sao Paulo
Collaborators
Universidade Cidade de Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03136042
Brief Title
Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children
Official Title
A Randomized Crossover Study of Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2016 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
July 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Universidade Cidade de Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study evaluated whether physiotherapy is efficient in sputum induction and in evaluation of pulmonary inflammation in asthmatic children.
Detailed Description
The hypertonic saline is a traditional technique to collect induced sputum, it´s safe and viable in asthmatic children, as well as the technique of sputum induction and processing has been standardized for schoolchildren.
Sometimes researchers have difficulties to obtain induced sputum in stable patients and it´s possible to use physiotherapy maneuvers to induced sputum. The manouvers are safe for adult and children asthmatics stable.
This study aimed to evaluate the effectiveness to collect induced sputum by physiotherapy maneuvers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomized in first visits into crossover techniques: (i) hypertonic saline (3%) - HS technique; (ii) physiotherapy techniques (oscillatory positive expiratory pressure, forced expiration and acceleration of expiratory flow) - P technique; (iii) hypertonic saline + physiotherapy techniques - HSP technique. All children attended three visits and 90 samples were collected. All patients underwent induced sputum and pulmonary function before and after bronchodilator.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
physiotherapists maneuvers
Arm Type
Experimental
Arm Description
physiotherapy techniques
Arm Title
hypertonic saline 3%
Arm Type
Active Comparator
Arm Description
four nebulizations with 3% hypertonic saline.
Arm Title
saline + physiotherapy maneuvers
Arm Type
Active Comparator
Arm Description
1 nebulizations + physiotherapy techniques
Intervention Type
Other
Intervention Name(s)
physiotherapy techniques
Intervention Description
oscillating positive expiratory pressure during nonstop 5 minutes. After that more five minutes to a forced expiratory technique
Intervention Type
Other
Intervention Name(s)
hypertonic saline 3%
Intervention Description
four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer
Intervention Type
Other
Intervention Name(s)
saline + physiotherapy maneuvers
Intervention Description
sputum induction by hypertonic saline at 3% for seven minutes. And more five minutes under physiotherapists maneuvers
Primary Outcome Measure Information:
Title
Sputum induction by physiotherapists maneuvers
Description
children were seated in a position where the thorax was inclined forwards by 45°, they were instructed to perform calm and long exhalations by oscillating positive expiratory pressure (OPEP) during nonstop 5 minutes holding a Flutter® (Scandipharm, Birmingham, AL, EUA). After that, children were positioned in supine zero degree and underwent for more five minutes to a forced exhalation with the open mouth/glottis (huffing) associated to acceleration by forced expiratory technique (FET), performed by the therapist by positioning a hand on xiphoid process and the other in the manubrium sternum.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Sputum induction by hypertonic saline 3%
Description
children received until four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer (Ultraneb 99; DeVilbiss, Somerset, PA) each challenge was monitored with PEF between nebulizations.
Time Frame
3 days
Other Pre-specified Outcome Measures:
Title
Sputum induction by hypertonic saline 3% associated with physiotherapists maneuvers
Description
Firstly, children underwent sputum induction by hypertonic saline at 3% for seven minutes. Second, they underwent five minutes OPEP and then five minutes of huffing and FET, as described above.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Asthmathic children used inhaled corticosteroids not associated with long-acting beta2-agonist.
Exclusion Criteria:
Asthmathic children to diagnose with other chronic pulmonary pathologies (cystic fibrosis, ciliary dyskinesia, bronchiolitis obliterans, and bronchopulmonary dysplasia) before study, no significant pulmonary pathologies, incapacity to realize pulmonary function and insufficient sample.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz s Romanholo, Dr
Organizational Affiliation
Universidade Cidade de Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Institute of the Clinical Hospital of University of Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31994616
Citation
Felicio-Junior EL, Barnabe V, de Almeida FM, Avona MD, de Genaro IS, Kurdejak A, Eller MCN, Verganid KP, Rodrigues JC, Tiberio IFLC, Martins MA, Saraiva-Romanholo BM. Randomized trial of physiotherapy and hypertonic saline techniques for sputum induction in asthmatic children and adolescents. Clinics (Sao Paulo). 2020 Jan 24;75:e1512. doi: 10.6061/clinics/2020/e1512. eCollection 2020. Erratum In: Clinics (Sao Paulo). 2021 Aug 27;76:e1512err.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
references
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pubmed/
Available IPD/Information Comments
GINA. Global Strategy for Asthma Management and Prevention NHLBI/WHO Workshop Report 2012. 2012 ISAAC. Worldwide variations in the prevalence of asthma symptoms: the International Study of Asthma and Allergies in Childhood (ISAAC). Eur Respir J 1998; 12:315-335 Solé D, Wandalsen GF, Camelo-Nunes IC, et al. Prevalence of symptoms of asthma, rhinitis, and atopic eczema among Brazilian children and adolescents identified by the International Study of Asthma and Allergies in Childhood (ISAAC) - Phase 3. J Pediatr (Rio J) 2006; 82:341-346 Barnabé V, Saraiva B, Stelmach R, et al. Chest physiotherapy does not induce bronchospasm in stable asthma. Physiotherapy 2003; 89:714-719 ATS. Standardization of Spirometry - American Thoracic Society. Am J Respir Crit Care Med 1995; 152:1107-1136 Saraiva-Romanholo BM, Barnabe V, Carvalho AL, et al. Comparison of three methods for differential cell count in induced sputum. Chest 2003; 124:1060-1066
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Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children
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