AsthmaNCT03136042
Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children
A study testing physiotherapy techniques, hypertonic saline 3% and saline + physiotherapy maneuvers in people with Asthma, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study evaluated whether physiotherapy is efficient in sputum induction and in evaluation of pulmonary inflammation in asthmatic children. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- physiotherapy techniques, hypertonic saline 3% and saline + physiotherapy maneuvers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jan 2016to 5 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Asthmathic children used inhaled corticosteroids not associated with long-acting beta2-agonist.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Children's Institute of the Clinical Hospital of University of Sao Paulo
São Paulo, São Paulo, 01246903
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- physiotherapy techniques, hypertonic saline 3%, saline + physiotherapy maneuvers
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapy techniquesOther
oscillating positive expiratory pressure during nonstop 5 minutes. After that more five minutes to a forced expiratory technique
hypertonic saline 3%Other
four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer
saline + physiotherapy maneuversOther
sputum induction by hypertonic saline at 3% for seven minutes. And more five minutes under physiotherapists maneuvers
| Study group | Role | What they receive |
|---|---|---|
| physiotherapists maneuvers | Experimental | physiotherapy techniques Receives: Other: physiotherapy techniques |
| hypertonic saline 3% | Active comparator | four nebulizations with 3% hypertonic saline. Receives: Other: hypertonic saline 3% |
| saline + physiotherapy maneuvers | Active comparator | 1 nebulizations + physiotherapy techniques Receives: Other: saline + physiotherapy maneuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (1)
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start15 Jan 2016
- Primary completion31 Aug 2017
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Cidade de Sao Paulo
- Responsible party
- Principal investigator, Beatriz Mangueira Saraiva Romanholo, University of Sao Paulo
- Investigators
- Beatriz s Romanholo, Dr, Principal investigator, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136042
- Sponsor's protocol ID
- UNICID
- Status last verified
- Apr 2019
- First submitted
- 27 Apr 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31994616
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Study of Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children.
- ClinicalTrials.gov ID
- NCT03136042
- Acronym / sponsor ID
- UNICID
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Universidade Cidade de Sao Paulo
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| physiotherapists maneuvers | Experimental | Other: physiotherapy techniquesphysiotherapy techniques |
| hypertonic saline 3% | Active comparator | Other: hypertonic saline 3%four nebulizations with 3% hypertonic saline. |
| saline + physiotherapy maneuvers | Active comparator | Other: saline + physiotherapy maneuvers1 nebulizations + physiotherapy techniques |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Asthmathic children used inhaled corticosteroids not associated with long-acting beta2-agonist.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiotherapy techniquesoscillating positive expiratory pressure during nonstop 5 minutes. After that more five minutes to a forced expiratory technique | Other | physiotherapists maneuvers |
| hypertonic saline 3%four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer | Other | hypertonic saline 3% |
| saline + physiotherapy maneuverssputum induction by hypertonic saline at 3% for seven minutes. And more five minutes under physiotherapists maneuvers | Other | saline + physiotherapy maneuvers |
Primary outcome
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.
1 secondary outcome
Sputum induction by hypertonic saline 3%
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Derived from this study: PubMed 31994616Felicio-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz s Romanholo, Dr principal investigator
Universidade Cidade de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy techniques, hypertonic saline 3% and saline + physiotherapy maneuvers in people with Asthma, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sputum induction by physiotherapists maneuvers (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.