Attitude to HealthNCT03510585
Mucociliary Clearance, Airway Inflammation and Nasal Symptoms in Urban Motorcycle-drivers
A study testing saline and sniffing and sniffing in people with Attitude to Health, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
Professionals working in polluted areas may present increased airways symptoms and dysfunction. Rhinopharyngeal retrograde clearance (RRC) has been used to improve mucus clearance in infants with bronchitis and bronchiolitis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Attitude to Health
- What is being tested?
- saline and sniffing and sniffing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2012to Aug 2012
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Professional motorcyclists aged 18 years to 45 years
- Agreement with the written informed consent
Who cannot join
- inability to understand and to follow commands,
- previous nasal surgery,
- respiratory infection in the previous 30 days
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais
Faculdade de Medicina da Universidade de São Paulo
São Paulo, 1246-903
About this study
Professionals working in polluted areas may present increased airways symptoms and dysfunction. Rhinopharyngeal retrograde clearance (RRC) has been used to improve mucus clearance in infants with bronchitis and bronchiolitis. Flushing the nasal cavity with saline (S) has been used to reduce nasal inflammation in rhinitis and sinupathies. The aim of this study was to assess the effects of RRC and RRC plus S (RRC+S) on the airways in professional motorcyclists. Twenty-four male motorcyclists (mean age 36 years) were randomly assigned to RRC or RRC+S. Subjects were assessed at baseline and 15 days after interventions for airways assessments by saccharin test, mucus contact angle, cellularity in nasal lavage and airways symptoms with the use of SNOT-20 questionnaire. Data were analyzed by nonparametric ANOVA for repeated measures with Bonferroni´s correction. A passive nitrogen dioxide monitoring system was used to assess the mean personal air pollution exposure along the study period (NO2). The association between NO2 and the airways outcomes was analyzed by Spearman correlation test. At baseline, the two groups were similar in clinical, demographics and working aspects. From them, 100% had airways symptoms complaints and 33% had nasal MCC impairment. After treatments, both groups presented improvements in airways symptoms and nasal MCC. However, increased number of macrophages and ciliated cells were observed in nasal lavage of both groups. No associations between nitrogen dioxide and the outcome variables were detected. Rhinopharyngeal retrograde clearance seems to be useful in the clinical management of the upper airways symptoms and dysfunction in adults.
Read the detailed description
The nonsmokers subjects aged 18 years to 45 years were enrolled in this study after agreement with the written informed consent. Subjects were randomly assigned to 15-days of one of the following interventions: RRC and RRC+S. Non pharmacological respiratory approaches may be useful in the management of the respiratory symptoms and dysfunctions air pollution-related. The purpose of this study was to determine whether saline instillation and/or retrograde rhinopharyngeal retrograde clearance are effective in the treatment of upper airways dysfunction through nasal mucociliary clearance, mucus properties, pH, cellularity and cytokines in nasal lavage and pH in exhaled breath condensate, as well as the airways symptoms (cough, wheeze, runny nose, hoarseness, among others) in motorcyclists due to urban air pollution.
- Conditions
- Attitude to Health
- Being tested
- saline and sniffing, sniffing
- Keywords
- mucociliary clearance, air pollution, nasal lavage, exhaled breath condensate, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saline and sniffingOther
This technique is a combination of positioning (laying down), saline instilation (5 ml in each side), sniffing (the side that received saline instilation) and throat vibration. Then the other side.
sniffingOther
This technique is a combination of positioning (laying down), sniffing (the side that received saline instilation) and throat vibration. Then the other side.
| Study group | Role | What they receive |
|---|---|---|
| saline and sniffing | Experimental | This RRC is the combination of positioning (laying down), sniffing (only one side), throat vibration and saline instillation. And then the other side. Receives: Other: saline and sniffing |
| sniffing | Placebo comparator | Pacient will be in a lay down condition and will perform sniffing with throat vibration several times each side (but with no saline instillation) Receives: Other: sniffing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal mucociliary clearance
Saccharine transit time test.
Measured: 15 days
Secondary outcomes (1)
Mucus physical properties
Contact angle
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study startJul 2012
- Primary completionAug 2012
- Study completionAug 2012
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 Attitude to HealthStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Naomi Kondo Nakagawa, University of Sao Paulo
- Investigators
- Paulo HN Saldiva, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510585
- Sponsor's protocol ID
- CEP-FMUSP 221/11
- Status last verified
- Apr 2018
- First submitted
- 18 Jun 2013
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brant TC, Yoshida CT, Carvalho Tde S, Nicola ML, Martins JA, Braga LM, Oliveira RC, Leyton V, Andre CS, Saldiva PH, Rubin BK, Nakagawa NK. Mucociliary clearance, airway inflammation and nasal symptoms in urban motorcyclists. Clinics (Sao Paulo). 2014;69(12):867-70. doi: 10.6061/clinics/2014(12)13.
PubMed 25628001
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucociliary Clearance, Airway Inflammation and Nasal Symptoms in Urban Motorcycle-drivers
- ClinicalTrials.gov ID
- NCT03510585
- Acronym / sponsor ID
- CEP-FMUSP 221/11
- Conditions
- Attitude to Health
- Keywords
- mucociliary clearance, air pollution, nasal lavage, exhaled breath condensate, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Apr 2018 (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.
Professionals working in polluted areas may present increased airways symptoms and dysfunction. Rhinopharyngeal retrograde clearance (RRC) has been used to improve mucus clearance in infants with bronchitis and bronchiolitis. Flushing the nasal cavity with saline (S) has been used to reduce nasal inflammation in rhinitis and sinupathies. The aim of this study was to assess the effects of RRC and RRC plus S (RRC+S) on the airways in professional motorcyclists. Twenty-four male motorcyclists (mean age 36 years) were randomly assigned to RRC or RRC+S. Subjects were assessed at baseline and 15 days after interventions for airways assessments by saccharin test, mucus contact angle, cellularity in nasal lavage and airways symptoms with the use of SNOT-20 questionnaire. Data were analyzed by nonparametric ANOVA for repeated measures with Bonferroni´s correction. A passive nitrogen dioxide monitoring system was used to assess the mean personal air pollution exposure along the study period (NO2). The association between NO2 and the airways outcomes was analyzed by Spearman correlation test. At baseline, the two groups were similar in clinical, demographics and working aspects. From them, 100% had airways symptoms complaints and 33% had nasal MCC impairment. After treatments, both groups presented improvements in airways symptoms and nasal MCC. However, increased number of macrophages and ciliated cells were observed in nasal lavage of both groups. No associations between nitrogen dioxide and the outcome variables were detected. Rhinopharyngeal retrograde clearance seems to be useful in the clinical management of the upper airways symptoms and dysfunction in adults.
Detailed description
The nonsmokers subjects aged 18 years to 45 years were enrolled in this study after agreement with the written informed consent. Subjects were randomly assigned to 15-days of one of the following interventions: RRC and RRC+S. Non pharmacological respiratory approaches may be useful in the management of the respiratory symptoms and dysfunctions air pollution-related. The purpose of this study was to determine whether saline instillation and/or retrograde rhinopharyngeal retrograde clearance are effective in the treatment of upper airways dysfunction through nasal mucociliary clearance, mucus properties, pH, cellularity and cytokines in nasal lavage and pH in exhaled breath condensate, as well as the airways symptoms (cough, wheeze, runny nose, hoarseness, among others) in motorcyclists due to urban air pollution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline and sniffing | Experimental | Other: saline and sniffingThis RRC is the combination of positioning (laying down), sniffing (only one side), throat vibration and saline instillation. And then the other side. |
| sniffing | Placebo comparator | Other: sniffingPacient will be in a lay down condition and will perform sniffing with throat vibration several times each side (but with no saline instillation) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Professional motorcyclists aged 18 years to 45 years
- Agreement with the written informed consent
Key exclusion criteria (3 listed)
- inability to understand and to follow commands,
- previous nasal surgery,
- respiratory infection in the previous 30 days
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 |
|---|---|---|
| saline and sniffingThis technique is a combination of positioning (laying down), saline instilation (5 ml in each side), sniffing (the side that received saline instilation) and throat vibration. Then the other side. | Other | saline and sniffing |
| sniffingThis technique is a combination of positioning (laying down), sniffing (the side that received saline instilation) and throat vibration. Then the other side. | Other | sniffing |
Primary outcome
Nasal mucociliary clearance
Time frame: 15 days
Saccharine transit time test.
1 secondary outcome
Mucus physical properties
Time frame: 15 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 27 Apr 2018.
- Results publication: PubMed 25628001Brant TC, Yoshida CT, Carvalho Tde S, Nicola ML, Martins JA, Braga LM, Oliveira RC, Leyton V, Andre CS, Saldiva PH, Rubin BK, Nakagawa NK. Mucociliary clearance, airway inflammation and nasal symptoms in urban motorcyclists. Clinics (Sao Paulo). 2014;69(12):867-70. doi: 10.6061/clinics/2014(12)13.
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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.
Paulo HN Saldiva, PhD study director
University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saline and sniffing and sniffing in people with Attitude to Health, run by University of Sao Paulo at 2 sites 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 2 inclusion and 3 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 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Nasal mucociliary clearance (time frame: 15 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 NCT03510585, 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 27 Apr 2018.