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

NCT02802891 | Completed DMC

• 1 other identifier: SFRH/BD/108605/2015
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Atopy

Keywords

Asthma; Allergy; Diagnosis; Endocrine disruptors; Children

Outcome Measures

Primary Outcomes (1)

• Volatile organic compounds in the exhaled breath condensate

  Volatile organic compounds, released from EBC through heating, will be measured by an electronic nose system

  4 to 8 months after recruitment

Secondary Outcomes (4)

• Endocrine disruptors in the urine

  4 to 8 months after recruitment

• ISAAC-based questionnaire

  4 to 8 months after recruitment

• 24h food questionnaire

  4 to 8 months after recruitment

• Endocrine disruptors in the house dust

  4 to 8 months after recruitment

Other Outcomes (2)

• Skin prick tests

  During recruitment

• Spirometry with bronchodilation

  During recruitment

Study Arms (1)

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)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Centro Hospitalar S. João

Porto, Portugal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Exhaled breath condensate (no DNA) Urine (DNA)

MeSH Terms

Conditions

Asthma; Hypersensitivity; Disease

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• André Moreira, MD PhD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 16, 2016
• Study Start: December 1, 2015
• Primary Completion: September 13, 2017
• Study Completion: September 13, 2017
• Last Updated: January 8, 2018

Record last verified: 2017-09

Locations

PT (1)