Airway Inflammatory Profile Among Cleaning Workers From Different Workplaces

Not Applicable

Completed

• Conditions: Asthma, Occupational; Inflammation; Rhinitis; Work Related Illnesses; Symptoms and Signs
• Interventions: Other: Nasal swab; Other: Questionnaires

• Registration Number: NCT03311048
• Lead Sponsor: University of Sao Paulo

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-02-01
• Primary Completion: 2017-04-01
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-16
• Study Completion: 2017-12-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hospital	Nasal swab	Hospital cleaning workers 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.
University	Questionnaires	Campus (university) cleaning workers 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.
Control	Nasal swab	Office workers (no relationship to cleaning) 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.
Housekeeper	Nasal swab	Housemaid (cleaning workers) 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.
Housekeeper	Questionnaires	Housemaid (cleaning workers) 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.
Control	Questionnaires	Office workers (no relationship to cleaning) 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.
Hospital	Questionnaires	Hospital cleaning workers 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.
University	Nasal swab	Campus (university) cleaning workers 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 Outcome Measures

Name	Time	Method
Cell differentiation for the evaluation of nasal epithelial inflammation	One day	Nasal swab will be collected to analyze cell differentiation
Measure of respiratory symptoms	One day	Questionnaires to analyze respiratory symptons

Trial Locations

Locations (1)

Children's Institute of the Clinical Hospital of University of Sao Paulo; 🇧🇷 São Paulo, Sao Paulo, Brazil