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Trial record 8 of 12 for:    Endocrine Disruptors

The JOIN Project: The Air in Diagnosis and Prevention of Asthma and Allergy (JOIN)

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ClinicalTrials.gov Identifier: NCT02802891
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Universidade do Porto

Brief Summary:
The JOIN project combines the health and indoor environment research areas to contribute in the development and validation of a new asthma diagnosis method through exhaled VOC analysis. This method is more sensitive, more specific, and completely non-invasive. Moreover, the JOIN project will assess the impact of exposure to the indoor environment, namely endocrine disruptors, on asthma and allergy development in children.

Condition or disease
Asthma Atopy

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Projeto JOIN - o ar Como Meio de prevenção e a diagnóstico da Asma e Alergia
Actual Study Start Date : December 2015
Actual Primary Completion Date : September 13, 2017
Actual Study Completion Date : September 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
Recruitment group

Group of individuals (aged 6 to 18 years old) recruited for the JOIN project. Consent was obtained from legal guardians for individuals under 18.

Exclusion criteria:

  • Individuals who refused to partake in the clinical assessment, despite the legal guardians consent.
  • Individuals who provided an insufficient amount of sample (ex: low volume of EBC)



Primary Outcome Measures :
  1. Volatile organic compounds in the exhaled breath condensate [ Time Frame: 4 to 8 months after recruitment ]
    Volatile organic compounds, released from EBC through heating, will be measured by an electronic nose system


Secondary Outcome Measures :
  1. Endocrine disruptors in the urine [ Time Frame: 4 to 8 months after recruitment ]
  2. ISAAC-based questionnaire [ Time Frame: 4 to 8 months after recruitment ]
  3. 24h food questionnaire [ Time Frame: 4 to 8 months after recruitment ]
  4. Endocrine disruptors in the house dust [ Time Frame: 4 to 8 months after recruitment ]

Other Outcome Measures:
  1. Skin prick tests [ Time Frame: During recruitment ]
    Performed during the regular examination in the outpatient clinic. Requested by the physician.

  2. Spirometry with bronchodilation [ Time Frame: During recruitment ]
    Performed during the regular examination in the outpatient clinic. Requested by the physician.


Biospecimen Retention:   Samples With DNA

Exhaled breath condensate (no DNA)

Urine (DNA)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children performing skin prick tests and spirometry with bronchodilation while attending immunoallergology consultations in the outpatients clinic of S. João Hospital Centre.
Criteria

Inclusion Criteria:

  • Individuals (6 to 18 years old) with skin prick tests and spirometry with bronchodilation results.

Exclusion Criteria:

  • Individuals with chronic diseases (other than asthma and atopy)
  • Planning to change home address in the next 4 months
  • Low volume of EBC
  • Refused to participate despite signing written consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802891


Locations
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Portugal
Centro Hospitalar S. João
Porto, Portugal
Sponsors and Collaborators
Universidade do Porto
Investigators
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Principal Investigator: André Moreira, MD PhD Universidade do Porto

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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT02802891     History of Changes
Other Study ID Numbers: SFRH/BD/108605/2015
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: September 2017

Keywords provided by Universidade do Porto:
Asthma
Allergy
Diagnosis
Endocrine disruptors
Children

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases