Evidence Driven Indoor Air Quality Improvement

NCT05992389 | Unknown

• 1 other identifier: SCH-EU101057497
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to identify the underlying disease mechanisms driving specific asthma phenotypes as well as certain disease outcomes and their relation to impaired indoor air quality. This may also help in underpinning specific target mechanisms in order to personalize and improve current treatment options in childhood asthma and develop more successful prevention strategies. This will be done by combining data from detailed clinical phenotyping with multiple -omics data.

Conditions

Asthma in Children; Pollution; Exposure

Keywords

indoor air quality; asthma

Outcome Measures

Primary Outcomes (1)

• Change in the number of asthma exacerbations and severity

  The exacerbation rate and exacerbation severity will be recorded along with the treatment use (reliever medication, use of oral and parenteral corticosteroids etc.) During the patient examination the questionnaire will be used to record the number of asthma exacerbations and the therapy used. Asthmatic patients will be regularly controlled even more often in case of exacerbations.

  6 months

Secondary Outcomes (4)

• Change of asthma control

  6 months

• Lung function tests

  6 months

• Fractional exhaled nitric oxide (FeNO)

  6 months

• Use of controller medication

  6 months

Study Arms (2)

Children with asthma

School aged participants (6-14 yrs) with an established diagnosis of asthma

Non-asthmatic subjects (healthy control)

School aged participants (6-14 yrs), non-asthmatic subjects (negative history of allergic diseases)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Total of 200 children will be recruited for this study. 150 school aged children with asthma (6-14 years) from the Croatian capital and its surroundings (Zagreb) will be recruited to this study. These participants will be recruited from the outpatient clinic at the Srebrnjak Children's Hospital in Zagreb, Croatia, as well as matching control participants (non-asthmatic subjects, N=50).

You may qualify if:

• school aged participants with asthma (patients with a clinical diagnosis of asthma (according to European Respiratory Society (ERS) and American Thoracic Society (ATS) guidelines) for at least a year , being on a stable dose of anti-inflammatory treatment for at least one month with partially controlled or uncontrolled asthma according to GINA guidelines)
• non-asthmatic school aged participants (matching control subjects)
• signed informed consent, .

You may not qualify if:

• known inborn or perinatal pulmonary disease;
• pulmonary malformation;
• oxygen therapy after birth with a duration of more than 24h;
• ventilator support or mechanical ventilation after birth;
• diagnosis of cystic fibrosis;
• primary ciliary dyskinesia;
• heart failure diagnosed after birth affecting pulmonary circulation;
• major respiratory diseases such as e.g. interstitial lung disease,
• acute respiratory infection at recruitment,
• use of systemic corticosteroids,
• recent asthma-related visit to emergency department (in the past three weeks)
• coexistence of other serious chronic illness. Moreover, children will be excluded from study visits and biomaterial collection in the case of fever of at least 38.5°C during the last two weeks prior to the planned visit.

Sponsors & Collaborators

• Children's Hospital Srebrnjak: lead

Study Sites (1)

Children's Hospital Srebrnjak

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Mirjana Turkalj, Prof., MD

CONTACT

+38516391164; mturkalj@bolnica-srebrnjak.hr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: August 15, 2023
• Study Start: April 3, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

CR (1)