Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children

NCT03136042 | Completed

• 1 other identifier: UNICID
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  3 days

Secondary Outcomes (1)

• Sputum induction by hypertonic saline 3%

  3 days

Other Outcomes (1)

• Sputum induction by hypertonic saline 3% associated with physiotherapists maneuvers

  3 days

Study Arms (3)

physiotherapists maneuvers

EXPERIMENTAL

physiotherapy techniques

Other: physiotherapy techniques

hypertonic saline 3%

ACTIVE COMPARATOR

four nebulizations with 3% hypertonic saline.

Other: hypertonic saline 3%

saline + physiotherapy maneuvers

ACTIVE COMPARATOR

1 nebulizations + physiotherapy techniques

Other: saline + physiotherapy maneuvers

Interventions

physiotherapy techniques OTHER

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

physiotherapists maneuvers

hypertonic saline 3% OTHER

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

hypertonic saline 3%

saline + physiotherapy maneuvers OTHER

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

saline + physiotherapy maneuvers

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Asthmathic children used inhaled corticosteroids not associated with long-acting beta2-agonist.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Universidade Cidade de Sao Paulo: collaborator

Study Sites (1)

Children's Institute of the Clinical Hospital of University of Sao Paulo

São Paulo, São Paulo, 01246903, Brazil

Location

Related Publications (1)

• 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.

  PMID: 31994616 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Physical Therapy Modalities; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Beatriz s Romanholo, Dr

  Universidade Cidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 2, 2017
• Study Start: January 15, 2016
• Primary Completion: August 31, 2017
• Study Completion: July 5, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)