Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children

April 15, 2019 updated by: Beatriz Mangueira Saraiva Romanholo, University of Sao Paulo

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

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
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01246903
        • Children's Institute of the Clinical Hospital of University of Sao Paulo

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

7 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sputum induction by physiotherapists maneuvers
Time Frame: 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.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sputum induction by hypertonic saline 3%
Time Frame: 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.
3 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sputum induction by hypertonic saline 3% associated with physiotherapists maneuvers
Time Frame: 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.
3 days

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Collaborators

Universidade Cidade de Sao Paulo

Investigators

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

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)

January 15, 2016

Primary Completion (ACTUAL)

August 31, 2017

Study Completion (ACTUAL)

July 5, 2018

Study Registration Dates

First Submitted

April 27, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (ACTUAL)

May 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNICID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. references
    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

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.

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