- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03311048
Airway Inflammatory Profile Among Cleaning Workers From Different Workplaces
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Sao Paulo
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São Paulo, Sao Paulo, Brazil, 01246903
- Children's Institute of the Clinical Hospital of University of Sao Paulo
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hospital
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.
|
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.
|
Experimental: University
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.
|
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.
|
Experimental: Housekeeper
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.
|
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.
|
Experimental: Control
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of respiratory symptoms
Time Frame: One day
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Questionnaires to analyze respiratory symptons
|
One day
|
Cell differentiation for the evaluation of nasal epithelial inflammation
Time Frame: One day
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Nasal swab will be collected to analyze cell differentiation
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One day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: BEATRIZ BS Mangueira Saraiva-Romanholo, PhD, Universidade Cidade de Sao Paulo
- Study Chair: Edineia R Paz, Master, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Publications and helpful links
General Publications
- Manzano RM, Carvalho CR, Saraiva-Romanholo BM, Vieira JE. Chest physiotherapy during immediate postoperative period among patients undergoing upper abdominal surgery: randomized clinical trial. Sao Paulo Med J. 2008 Sep;126(5):269-73. doi: 10.1590/s1516-31802008000500005.
- Tatton-Brown K, Rahman N. EZH2-Related Overgrowth. 2013 Jul 18 [updated 2018 Aug 2]. In: Adam MP, Everman DB, 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/
- Aun MV, Saraiva-Romanholo BM, Almeida FM, Bruggemann TR, Kalil J, Martins Mde A, Arantes-Costa FM, Giavina-Bianchi P. Sensitization by subcutaneous route is superior to intraperitoneal route in induction of asthma by house dust mite in a murine mode. Einstein (Sao Paulo). 2015 Oct-Dec;13(4):560-6. doi: 10.1590/S1679-45082015AO3389.
- da Silva RA, Almeida FM, Olivo CR, Saraiva-Romanholo BM, Perini A, Martins MA, Carvalho CR. Comparison of the effects of aerobic conditioning before and after pulmonary allergic inflammation. Inflammation. 2015;38(3):1229-38. doi: 10.1007/s10753-014-0090-0.
- 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.
- Possa SS, Charafeddine HT, Righetti RF, da Silva PA, Almeida-Reis R, Saraiva-Romanholo BM, Perini A, Prado CM, Leick-Maldonado EA, Martins MA, Tiberio Ide F. Rho-kinase inhibition attenuates airway responsiveness, inflammation, matrix remodeling, and oxidative stress activation induced by chronic inflammation. Am J Physiol Lung Cell Mol Physiol. 2012 Dec 1;303(11):L939-52. doi: 10.1152/ajplung.00034.2012. Epub 2012 Sep 21.
- 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.
- Saraiva-Romanholo BM, Barnabe V, Carvalho AL, Martins MA, Saldiva PH, Nunes Mdo P. Comparison of three methods for differential cell count in induced sputum. Chest. 2003 Sep;124(3):1060-6. doi: 10.1378/chest.124.3.1060.
- 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.
- Paro-Heitor ML, Bussamra MH, Saraiva-Romanholo BM, Martins MA, Okay TS, Rodrigues JC. Exhaled nitric oxide for monitoring childhood asthma inflammation compared to sputum analysis, serum interleukins and pulmonary function. Pediatr Pulmonol. 2008 Feb;43(2):134-41. doi: 10.1002/ppul.20747.
- Saraiva-Romanholo BM, Machado FS, Almeida FM, Nunes Mdo P, Martins MA, Vieira JE. Non-asthmatic patients show increased exhaled nitric oxide concentrations. Clinics (Sao Paulo). 2009;64(1):5-10. doi: 10.1590/s1807-59322009000100002.
- Mendes FA, Goncalves RC, Nunes MP, Saraiva-Romanholo BM, Cukier A, Stelmach R, Jacob-Filho W, Martins MA, Carvalho CR. Effects of aerobic training on psychosocial morbidity and symptoms in patients with asthma: a randomized clinical trial. Chest. 2010 Aug;138(2):331-7. doi: 10.1378/chest.09-2389. Epub 2010 Apr 2.
- Hizume DC, Toledo AC, Moriya HT, Saraiva-Romanholo BM, Almeida FM, Arantes-Costa FM, Vieira RP, Dolhnikoff M, Kasahara DI, Martins MA. Cigarette smoke dissociates inflammation and lung remodeling in OVA-sensitized and challenged mice. Respir Physiol Neurobiol. 2012 Apr 30;181(2):167-76. doi: 10.1016/j.resp.2012.03.005. Epub 2012 Mar 15.
- Silva RA, Almeida FM, Olivo CR, Saraiva-Romanholo BM, Martins MA, Carvalho CR. Exercise reverses OVA-induced inhibition of glucocorticoid receptor and increases anti-inflammatory cytokines in asthma. Scand J Med Sci Sports. 2016 Jan;26(1):82-92. doi: 10.1111/sms.12411. Epub 2015 Feb 4.
- da Paz ER, de Lima CMF, Felix SN, Schaeffer B, Galvao CES, Correia AT, Righetti RF, de Arruda Martins M, de Fatima Lopes Calvo Tiberio I, Saraiva-Romanholo BM. Airway inflammatory profile among cleaning workers from different workplaces. BMC Pulm Med. 2022 Apr 29;22(1):170. doi: 10.1186/s12890-022-01949-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Otorhinolaryngologic Diseases
- Occupational Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Asthma
- Inflammation
- Rhinitis
- Asthma, Occupational
Other Study ID Numbers
- 15149013.3.0000.5463
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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Informed Consent Form
Information identifier: Sistema Nacional de Informação
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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