Asthma in Children Clinical Trial
— ImptoxOfficial title:
An Innovative Analytical Platform to Investigate the Effect and Toxicity of Micro and Nano Plastics Combined With Environmental Contaminants on the Risk of Allergic Disease in Preclinical and Clinical Studies
Verified date | September 2023 |
Source | Children's Hospital Srebrnjak |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Single-center, case-control, longitudinal, observational, population based cohort study with stratified sample (by age group, gender, and residential area).
Status | Recruiting |
Enrollment | 630 |
Est. completion date | February 28, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | Inclusion Criteria: - Proven sensitization to at least one food allergen with a diagnosis of at least one allergic disease for at least one year - Clinical diagnosis of allergic rhinitis (AR) for at least 1 year with symptoms of the nose, induced after exposure to allergens via IgE-mediated hypersensitivity reactions (symptoms of watery rhinorrhea, nasal obstruction, nasal itching and sneezing). - Diagnosis of atopic dermatitis (AD) with AD symptoms lasting for more than 3 months, with or without food allergy Additional inclusion criteria: • Significant clinical allergy to indoor and outdoor allergens, an food allergens with positive skin prick test (SPT) and specific IgE levels (>0.35kUA/L) Exclusion Criteria: - Known inborn or perinatal pulmonary disease; - Pulmonary malformation - Oxygen therapy after birth with a duration of more than 24 h - 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 and other congenital and serious chronic disease - Fever of at least 38.5 °C during the last two weeks prior to the planned visit |
Country | Name | City | State |
---|---|---|---|
Croatia | Children's Hospital Srebrnjak | Zagreb |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Srebrnjak | University of Belgrade |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ISAC platform | Detailed assessment of allergic sensitization will be performed using ISAC platform with the analysis of >100 allergic components of food and/or inhalatory allergens. Serum concentrations of the specific IgEs reacting to 103 allergen components from 43 allergen sources will be measured using the Multiplex Component Diagnosis (ISAC) platform. ISAC is a semi-quantitative test and results are reported in ISAC standard units (ISU) indicating specific IgE-antibody levels; the operating range is 0.3-100 ISU-E. This range is about the same as a concentration range of 0.3-100 kilo international units of allergen-specific antibody per unit volume of sample (kUA/litre) of IgE (1 kUA/litre is equal to 2.4 nanograms/ml). | Blood samples will be collected twice (at baseline and after 6 months) | |
Primary | Lung function tests | Forced expiratory volume in one second (FEV1), Forced vital capacity (FVC) and the ratio of the two volumes (FEV1/FVC) will be recorded for each patient at each visit.
FEV1 is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration. It's measured in % of predicted values which are the average readings that would be expected in a healthy person of similar age, gender, body size, and ethnicity. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters. |
6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations. | |
Secondary | Fractional exhaled nitric oxide (FeNO) | FeNO test measures the level of nitric oxide gas in an exhaled sample of breath. It is measured in "parts per billion" (ppb). | 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations | |
Secondary | Childhood Asthma Control Test (C-ACT) | C-ACT questionnaire will be used to tell us if the asthma treatment plan is optimal and if asthma is being properly controlled. For children 4 to 11 years maximal score is 27, and for those older then 12 years maximal score is 25. Higher scores reflect greater asthma control, and if the score is 19 or less may be a sign that asthma is not controlled as well as it could be. | 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations | |
Secondary | Daily burden of disease (Global evaluation) | Participants' daily burden of disease will be evaluated by visual analogue scale (VAS) Visual analogue scale levels <20/100 were categorized as "Low" burden and VAS levels =50/100 as "High" burden. | 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations | |
Secondary | Daily burden of disease (affecting Nose) | Participants with AR will be evaluated by visual analogue scale (VAS).Visual analogue scale levels <20/100 were categorized as "Low" burden and VAS levels =50/100 as "High" burden. | 6 months | |
Secondary | Daily burden of disease (affecting Eyes) | Participants' daily burden of the disease affecting eyes will be evaluated by visual analogue scale (VAS).Visual analogue scale levels <20/100 were categorized as "Low" burden and VAS levels =50/100 as "High" burden. | 6 months | |
Secondary | Daily burden of disease (Asthma) | Participants' daily burden of asthma will be evaluated by visual analogue scale (VAS).Visual analogue scale levels <20/100 were categorized as "Low" burden and VAS levels =50/100 as "High" burden. | 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations | |
Secondary | SCORing Atopic Dermatitis (SCORAD) | SCORAD as a clinical tool will be used to assess the extent and severity of eczema. The SCORAD Index formula is: A/5 + 7B/2 + C. In this formula A is defined as the extent (0- 100), B is defined as the intensity (0- 18) and C is defined as the subjective symptoms (0- 20). The maximal score of the SCORAD Index is 103. | 6 months for patients with AD |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
Recruiting |
NCT05734261 -
Forced Oscillations Technique During a Metacholine Test in Children
|
N/A | |
Recruiting |
NCT06044051 -
Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma
|
N/A | |
Completed |
NCT04896502 -
Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
|
N/A | |
Completed |
NCT03503812 -
Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches
|
N/A | |
Recruiting |
NCT06003569 -
Reducing Asthma Attacks in Disadvantaged School Children With Asthma
|
N/A | |
Not yet recruiting |
NCT05902702 -
Isotonic Saline for Children With Bronchiolitis
|
N/A | |
Not yet recruiting |
NCT05547477 -
Continuous EMG Measurements in Children With Asthma During Sleep
|
||
Completed |
NCT04388098 -
Oral Health Status of Asthmatic Children
|
||
Terminated |
NCT03586544 -
Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity
|
Phase 4 | |
Recruiting |
NCT04821908 -
Consequences of COVID 19 Pandemic on Childhood Asthma
|
||
Not yet recruiting |
NCT03277170 -
Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations
|
Phase 2 | |
Enrolling by invitation |
NCT06239844 -
Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English
|
N/A | |
Not yet recruiting |
NCT05974917 -
Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
|
||
Not yet recruiting |
NCT05997784 -
Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
|
||
Recruiting |
NCT05366309 -
Performance and Adherence in Children Using Spacers
|
N/A | |
Completed |
NCT05684926 -
COVID-19 Pandemic Asthma Child Telerehabilitation Yoga
|
N/A | |
Recruiting |
NCT04166344 -
A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma
|
N/A | |
Completed |
NCT03673618 -
Soluble Corn Fiber Supplementation for Asthma
|
Phase 2 | |
Completed |
NCT03907410 -
The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial
|
N/A |