Clinical trial NCT03136042: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Universidade Cidade de Sao Paulo
First posted: 2017-05-02
Enrollment: 33
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Sputum induction by physiotherapists maneuvers
timeFrame: 3 days
Secondary outcomes:
measure: Sputum induction by hypertonic saline 3%
timeFrame: 3 days
Other outcomes:
measure: Sputum induction by hypertonic saline 3% associated with physiotherapists maneuvers
timeFrame: 3 days
Locations:
city: São Paulo
country: Brazil
facility: Children's Institute of the Clinical Hospital of University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: Universidade Cidade de Sao Paulo
name: Beatriz s Romanholo, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.