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

NCT07230912 | Not Yet Recruiting FDA Drug

• 1 other identifier: bronchial asthma in children
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

• 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.

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• -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.

  one year

Study Arms (1)

comparing the mean of FEV1 between two independent groups(comorbidity in bronchial asthma )

Drug: Short Acting Beta 2 Agonist

Interventions

Short Acting Beta 2 Agonist DRUG

short acting drug

comparing the mean of FEV1 between two independent groups(comorbidity in bronchial asthma )

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Roffel MP, Bracke KR, Heijink IH, Maes T. miR-223: A Key Regulator in the Innate Immune Response in Asthma and COPD. Front Med (Lausanne). 2020 May 19;7:196. doi: 10.3389/fmed.2020.00196. eCollection 2020.

  PMID: 32509795 RESULT

• Vafadar A, Alashti SK, Khazayel S, Babadi S, Eghtesadi M, Younesi M, Savardashtaki A, Negahdaripour M. Meta-analysis of microarray data to identify potential signature genes and MiRNAs associated with the pathogenesis of asthma. J Transl Med. 2025 Jul 15;23(1):796. doi: 10.1186/s12967-025-06646-5.

  PMID: 40665411 RESULT

• Martin J, Townshend J, Brodlie M. Diagnosis and management of asthma in children. BMJ Paediatr Open. 2022 Apr;6(1):e001277. doi: 10.1136/bmjpo-2021-001277.

  PMID: 35648804 RESULT

• Sobieraj DM, Weeda ER, Nguyen E, Coleman CI, White CM, Lazarus SC, Blake KV, Lang JE, Baker WL. Association of Inhaled Corticosteroids and Long-Acting beta-Agonists as Controller and Quick Relief Therapy With Exacerbations and Symptom Control in Persistent Asthma: A Systematic Review and Meta-analysis. JAMA. 2018 Apr 10;319(14):1485-1496. doi: 10.1001/jama.2018.2769.

  PMID: 29554195 RESULT

• Taherian MR, Fatemian F, Halimi A, Soleimani Y, Jorjani G, Nozari P, Mosavi Jarrahi A, Nazari SSH, Al-Yateem N, Al-Marzouqi A, Humid A, Rahman SA. Prevalence of asthma among children and adolescents in WHO's Eastern Mediterranean Region: a meta-analysis of over 0.5 million participants. BMC Public Health. 2024 Aug 7;24(1):2148. doi: 10.1186/s12889-024-18716-2.

  PMID: 39112964 RESULT

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

Study Officials

• Mohamed Mahrous El Tallawy, professor of pediatrics

  Assiut university children hospital

  STUDY CHAIR

• Yasser Gamal Abdel-Rahman, Assistant Professor

  Assiut university children hospital

  PRINCIPAL INVESTIGATOR

• Ahmed Zohri Yasin, Lecturer of Pediatrics

  Assiut university children hospital

  STUDY DIRECTOR

Central Study Contacts

Aghapy Gamal Zahy, assistant Lecturer

CONTACT

+20 1287584229; AghapyGamal@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecteurer of pediatrics

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: November 17, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share