Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT03136042

Collaborator

Universidade Cidade de Sao Paulo (Other)

Enrollment

Location

Arms

29.6

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluated whether physiotherapy is efficient in sputum induction and in evaluation of pulmonary inflammation in asthmatic children.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Other: physiotherapy techniques Other: hypertonic saline 3% Other: saline + physiotherapy maneuvers	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

A Randomized Crossover Study of Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children.

Actual Study Start Date :

Jan 15, 2016

Actual Primary Completion Date :

Aug 31, 2017

Actual Study Completion Date :

Jul 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: physiotherapists maneuvers physiotherapy techniques	Other: physiotherapy techniques oscillating positive expiratory pressure during nonstop 5 minutes. After that more five minutes to a forced expiratory technique
Active Comparator: hypertonic saline 3% four nebulizations with 3% hypertonic saline.	Other: hypertonic saline 3% four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer
Active Comparator: saline + physiotherapy maneuvers 1 nebulizations + physiotherapy techniques	Other: saline + physiotherapy maneuvers sputum induction by hypertonic saline at 3% for seven minutes. And more five minutes under physiotherapists maneuvers

Arm

Intervention/Treatment

Experimental: physiotherapists maneuvers

physiotherapy techniques

Other: physiotherapy techniques

oscillating positive expiratory pressure during nonstop 5 minutes. After that more five minutes to a forced expiratory technique

Active Comparator: hypertonic saline 3%

four nebulizations with 3% hypertonic saline.

Other: hypertonic saline 3%

four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer

Active Comparator: saline + physiotherapy maneuvers

1 nebulizations + physiotherapy techniques

Other: saline + physiotherapy maneuvers

sputum induction by hypertonic saline at 3% for seven minutes. And more five minutes under physiotherapists maneuvers

Outcome Measures

Primary Outcome Measures

Sputum induction by physiotherapists maneuvers [3 days]
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% [3 days]
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.

Other Outcome Measures

Sputum induction by hypertonic saline 3% associated with physiotherapists maneuvers [3 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Institute of the Clinical Hospital of University of Sao Paulo	São Paulo	Sao Paulo	Brazil	01246903

Sponsors and Collaborators

University of Sao Paulo
Universidade Cidade de Sao Paulo

Investigators

Principal Investigator: Beatriz s Romanholo, Dr, Universidade Cidade de Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beatriz Mangueira Saraiva Romanholo, PhD, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT03136042

Other Study ID Numbers:

UNICID

First Posted:

May 2, 2017

Last Update Posted:

Apr 17, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Asthma

Study Results

No Results Posted as of Apr 17, 2019