An interventional study of Nasal swab and Questionnaires in Inflammation, Work Related Illnesses and Symptoms and Signs, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-30.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Other
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.
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).
221 studies on the registry are indexed under Signs and Symptoms; 22 are open to participants now.
This study's enrollment of 167 is above the median of 78 across 152 interventional studies indexed under Signs and Symptoms.
Browse Signs and Symptoms studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Signs and Symptoms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Nasal swab · Other: 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.
Other: Nasal swab · Other: 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.
Other: Nasal swab · Other: 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.
Other: Nasal swab · Other: Questionnaires
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.
Measure of respiratory symptoms
Questionnaires to analyze respiratory symptons
Time frame: One day
Cell differentiation for the evaluation of nasal epithelial inflammation
Nasal swab will be collected to analyze cell differentiation
Time frame: One day
Plan to share: No
Ran from Feb 2015 to primary completion in Apr 2017, 26 months.
Of 58 non-industry interventional studies with no phase under Signs and Symptoms, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 26 months is above that.
Counting every sponsor, half of 69 studies reached it within 17 months; a quarter within 6 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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