NCT03311048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

2.2 years

First QC Date

May 19, 2017

Last Update Submit

March 28, 2018

Conditions

Keywords

Cleaning workersWork-related asthmaWork-related rhinitisRespiratory symptomsNasal swab

Outcome Measures

Primary Outcomes (2)

  • Measure of respiratory symptoms

    Questionnaires to analyze respiratory symptons

    One day

  • Cell differentiation for the evaluation of nasal epithelial inflammation

    Nasal swab will be collected to analyze cell differentiation

    One day

Study Arms (4)

Hospital

EXPERIMENTAL

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 swabOther: Questionnaires

University

EXPERIMENTAL

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 swabOther: Questionnaires

Housekeeper

EXPERIMENTAL

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 swabOther: Questionnaires

Control

EXPERIMENTAL

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 swabOther: Questionnaires

Interventions

Nasal swab was collect to upper airways inflammation evaluation.

ControlHospitalHousekeeperUniversity

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.

ControlHospitalHousekeeperUniversity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 01246903, Brazil

Location

Related Publications (15)

  • Ocansey S, Tatton-Brown K. EZH2-Related Overgrowth. 2013 Jul 18 [updated 2025 Jun 26]. In: Adam MP, Bick S, Mirzaa GM, Pagon RA, Wallace SE, Amemiya A, editors. GeneReviews(R) [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2026. Available from http://www.ncbi.nlm.nih.gov/books/NBK148820/

    PMID: 23865096BACKGROUND
  • 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.

    PMID: 26761554BACKGROUND
  • 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.

    PMID: 25537797BACKGROUND
  • 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.

    PMID: 25012028BACKGROUND
  • 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.

    PMID: 23002076BACKGROUND
  • 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.

    PMID: 19099160BACKGROUND
  • 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.

    PMID: 19488541BACKGROUND
  • 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.

    PMID: 12970038BACKGROUND
  • 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.

    PMID: 15951906BACKGROUND
  • 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.

    PMID: 18085692BACKGROUND
  • 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.

    PMID: 19142544BACKGROUND
  • 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.

    PMID: 20363839BACKGROUND
  • 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.

    PMID: 22446562BACKGROUND
  • 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.

    PMID: 25652754BACKGROUND
  • 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.

MeSH Terms

Conditions

InflammationSigns and SymptomsAsthma, OccupationalRhinitisSigns and Symptoms, Respiratory

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOccupational DiseasesRespiratory Tract InfectionsInfectionsNose DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants, divided in four groups based on workplace: Hospital, University, Housekeeper and Control.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: : 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 19, 2017

First Posted

October 16, 2017

Study Start

February 1, 2015

Primary Completion

April 1, 2017

Study Completion

December 1, 2017

Last Updated

March 30, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Informed Consent Form (Sistema Nacional de Informação)Access

Locations