Impact of Comorbidities, Some Biomarkers, Micro RNA in Childhood Asthma Phenotypes

ConditionBronchial Asthma

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age6-12

SponsorAssiut University

About this trial

* Assess response to treatment in children with bronchial asthma attending Assiut university children hospital. * Role of comorbidities in controlling symptoms of bronchial asthma. * Evaluate the role of the soluable interleukin 5 receptor, I C-telopeptide of type I collagen (ICTP), miR-223-3p and miR-191-5p in bronchial asthma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 6-12 years diagnosed asthma, inpatient or attending pediatric outpatient clinic of Assiut university children hospital.

Disqualifiers

- Chronic respiratory illness other than asthma (e.g., bronchiectasis, CF)

Known immunodeficiency or systemic illness

patients with skeletal deformities

patients suspected inborn errors of metabolism

Trial population

Data Collection Tools: History * Personal history * A detailed history including the outline of respiratory symptoms, triggers for cough, wheeze, shortness of breath * Asthma history (duration, triggers, control status) * Therapeutic history (medications used during previous 12 months) History suggestive of GERD as: heart burn, regurgitation, vomiting * Past history of other allergic diseases as: Allergic rhinitis ,urtcaria and food allergy * positive family history of asthma and other allergic diseases Complete physical examination * BMI to assess obesity * Chest examination Investigations: * CBC (neutrophils-esinophils) * Inflammatory markers (ESR-CRP) * Total IgE * lipid profile * The soluable interleukin 5 receptor 1 * I C-telopeptide of type I collagen (ICTP) * miR-223-3p * miR-191-5p chest xray Pulmonary function test (spirometry) follow up patients as regards asthma control,exacerbation in one year

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Short Acting Beta 2 Agonist
Drug
short acting drug

Treatment groups

82 Participants

are divided into 1 treatment group

Group A: comparing the mean of FEV1 between two independent groups(comorbidity in bronchial asthma )1 intervention

Trial outcomes

Primary outcomes

-proportion of participants achieving clinical treatment response (forced expiratory volume in one second (FEV1) increase >12% from baseline). -association between baseline circulating micro RNA (miR-223-3p- miR-191-5p) and clinical treatment response.

* number and percentage of children showing improvment in lung function defined as an increase in forced expiratory volume in one second \>12 from baseline measured by standardized spirometry (pre and post bronchodilator) at one year. * correlation and between- group differences in baseline serum micoRNA levels (miR-223-3p- miR-191-5p) comparing responders vs non-responders in 1 year.

Time frame

one year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: