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Airway Inflammatory Profile Among Cleaning Workers From Different Workplaces

Primary Purpose

Inflammation, Work Related Illnesses, Symptoms and Signs

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nasal swab
Questionnaires
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammation focused on measuring Cleaning workers, Work-related asthma, Work-related rhinitis, Respiratory symptoms, Nasal swab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Institute of the Clinical Hospital of University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Hospital

University

Housekeeper

Control

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 19, 2017
Last Updated
March 28, 2018
Sponsor
University of Sao Paulo
Collaborators
Universidade Cidade de Sao Paulo, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03311048
Brief Title
Airway Inflammatory Profile Among Cleaning Workers From Different Workplaces
Official Title
Airway Inflammatory Profile Among Cleaning Workers From Different Workplaces
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Universidade Cidade de Sao Paulo, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Work Related Illnesses, Symptoms and Signs, Asthma, Occupational, Rhinitis
Keywords
Cleaning workers, Work-related asthma, Work-related rhinitis, Respiratory symptoms, Nasal swab

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Participants, divided in four groups based on workplace: Hospital, University, Housekeeper and Control.
Allocation
Non-Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hospital
Arm Type
Experimental
Arm Description
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.
Arm Title
University
Arm Type
Experimental
Arm Description
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.
Arm Title
Housekeeper
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nasal swab
Intervention Description
Nasal swab was collect to upper airways inflammation evaluation.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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 Measure Information:
Title
Measure of respiratory symptoms
Description
Questionnaires to analyze respiratory symptons
Time Frame
One day
Title
Cell differentiation for the evaluation of nasal epithelial inflammation
Description
Nasal swab will be collected to analyze cell differentiation
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BEATRIZ BS Mangueira Saraiva-Romanholo, PhD
Organizational Affiliation
Universidade Cidade de Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Edineia R Paz, Master
Organizational Affiliation
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Institute of the Clinical Hospital of University of Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23865096
Citation
Tatton-Brown K, Rahman N. EZH2-Related Overgrowth. 2013 Jul 18 [updated 2018 Aug 2]. In: Adam MP, Mirzaa GM, Pagon RA, Wallace SE, Bean LJH, Gripp KW, Amemiya A, editors. GeneReviews(R) [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2023. Available from http://www.ncbi.nlm.nih.gov/books/NBK148820/
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Citation
Brito JM, Macchione M, Yoshizaki K, Toledo-Arruda AC, Saraiva-Romanholo BM, Andrade Mde F, Mauad T, Rivero DH, Saldiva PH. Acute cardiopulmonary effects induced by the inhalation of concentrated ambient particles during seasonal variation in the city of Sao Paulo. J Appl Physiol (1985). 2014 Sep 1;117(5):492-9. doi: 10.1152/japplphysiol.00156.2014. Epub 2014 Jul 10.
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PubMed Identifier
23002076
Citation
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Citation
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Results Reference
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PubMed Identifier
19488541
Citation
de Amorim CG, Sa Malbouisson LM, Saraiva BM, Pedro FM, Martins MA, Carmona MJ. Evaluation of exhaled nitric oxide in patients undergoing myocardial revascularization with cardiopulmonary bypass. Rev Bras Anestesiol. 2009 May-Jun;59(3):286-96. doi: 10.1590/s0034-70942009000300003. English, Portuguese.
Results Reference
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PubMed Identifier
12970038
Citation
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Results Reference
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PubMed Identifier
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Citation
Palomino AL, Bussamra MH, Saraiva-Romanholo BM, Martins MA, Nunes Mdo P, Rodrigues JC. [Induced sputum in children and adolescents with asthma: safety, clinical applicability and inflammatory cells aspects in stable patients and during exacerbation]. J Pediatr (Rio J). 2005 May-Jun;81(3):216-24. Portuguese.
Results Reference
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Citation
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19142544
Citation
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Citation
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Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
http://portal2.saude.gov.br/sisnep/pesquisador
Available IPD/Information Identifier
Sistema Nacional de Informação

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Airway Inflammatory Profile Among Cleaning Workers From Different Workplaces

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