Clinical trial NCT03311048: Airway Inflammatory Profile Among Cleaning Workers From Different Workplaces
Official title: Airway Inflammatory Profile Among Cleaning Workers From Different Workplaces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Work Related Illnesses
Symptoms and Signs
Asthma, Occupational
Rhinitis
Keywords: Cleaning workers
Work-related asthma
Work-related rhinitis
Respiratory symptoms
Nasal swab
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Universidade Cidade de Sao Paulo
name: Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
First posted: 2017-10-16
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: : This study included 167 participants, divided in four groups based on workplace: Hospital, University, Housekeeper and Control. Nasal swab was collect to upper airways inflammation evaluation. Clinical profile and respiratory symptoms employees' evaluation were performed using specific questionnaires (European Community Respiratory Health Survey for occupational diseases evaluation (ECRHS), (adapted by Ribeiro et al, 2007) and the International Study of Asthma and Allergies in Childhood (ISAAC) - Asthma module, previously translated and validated.
Primary purpose: OTHER

Brief summary: There are consistent evidences through epidemiologic studies in different places, reinforced by occupational asthma records studies, that cleaning workers have a high risk in developing asthma. These risk determinants are not totally known. The air around the worker may have some higher and lower molecular weight with different concentration peaks from removed dust of the cleaning process and volatile substances from cleaning products. Cleaning activities may occur in different places. Although the relationship between rhinitis and asthma is already established, there are not many studies about occupational rhinitis-related work place. This study aimed to investigate airway inflammation and respiratory symptoms of cleaning workers from different workplaces.

Detailed description: Were recruited to participate in the study individuals from four different workplaces: Hospital; University; Housekeeper and Control (office workers). The research was performed in Cacoal city, Rondonia, Brazil. Smokers (active), pregnant, lactating, and individuals at continuing therapy for treating disorders of the airways were excluded.

Clinical profile and respiratory symptoms employees evaluation were performed using the European Community Respiratory Health Survey for occupational diseases evaluation (ECRHS), and the International Study of Asthma and Allergies in Childhood (ISAAC) - Asthma module.

Nasal swab was collected for evaluation of upper airways inflammation, according to Ronchetti et al protocol, using a sterile swab that was moistened with 1mL saline solution; both nostrils were scraped using this swab. Twenty minutes after this, laminas were stained using May-Grunwald-Giemsa to eosinophils, neutrophils, lymphocytes, macrophages and epithelial cells identification. Cells were analyzed using a Nikon E600 optical microscope (Nikon, Canada), of 1.000 x magnitude. Whenever possible a total of 200 cells were counted in two slides.

Statistical analysis were performed using Anova variance (Kruskal-Wallis) and Dunn's test for comparisons between groups. To evaluate the association between the qualitative variables we used the chi-square, Statistical software Sigma Plot 12.0 and SPSS 21.0. The confidence interval was 95% (p \<0.05).

Eligibility criteria: Inclusion Criteria:

* Cleaning workers from different workplaces
* Non-cleaning workers (control group)
* People legally capable (over 18 years old)
* Must be able to nasal swab collection and answer questionnaires
* Sign the informed consent form

Exclusion Criteria:

* Smokers (active)
* Pregnant (women)
* Lactating (women)
* Not accept the informed consent form
* Individuals at continuing therapy for airways treating disorders

Primary outcomes:
measure: Measure of respiratory symptoms
timeFrame: One day
measure: Cell differentiation for the evaluation of nasal epithelial inflammation
timeFrame: One day
Secondary outcomes:
Other outcomes:
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 BS Mangueira Saraiva-Romanholo, PhD
role: STUDY_CHAIR
affiliation: Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
name: Edineia R Paz, Master
role: STUDY_CHAIR
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