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Effect of Phenotype-Guided Versus GINA-Based Asthma Management on Asthma Control in Children and Adolescents in Southeast Nigeria

Effect of Phenotype-Guided Versus GINA-Based Asthma Management on Asthma Control in Children and Adolescents in Southeast Nigeria

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202510769379142
Enrollment
100
Registered
2025-10-20
Start date
2025-10-31
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory

Interventions

Phenotype Asthma Management
GINA Based Asthma Management

Sponsors

UNTH Enugu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children and adolescents aged 6 to 17 years Physician-diagnosed asthma for at least 6 months Stable clinical condition at enrollment (no acute exacerbation within the past 2 weeks) Ability to attend three scheduled clinic visits over a 12-month period Parent or guardian able to provide written informed consent Child able to provide assent, where applicable Resident within the study catchment area for the duration of follow-up Willingness to comply with study procedures and follow-up schedule

Exclusion criteria

Exclusion criteria: Children with other chronic respiratory conditions (e.g., cystic fibrosis, bronchiectasis) History of congenital heart disease or other significant cardiac pathology Presence of immunodeficiency or chronic systemic illness Acute asthma exacerbation within the past 2 weeks Use of systemic corticosteroids within the past 4 weeks Inability to perform spirometry or complete study assessments Planned relocation or inability to complete 12-month follow-up Refusal or inability to provide informed consent or assent

Design outcomes

Primary

MeasureTime frame
Asthma control status at 12 months, measured using the GINA asthma control tool (categorized as well-controlled, partly controlled, or uncontrolled).;Change in Health Belief Model (HBM) constructs, including perceived severity, susceptibility, benefits, barriers, cues to action, and self-efficacy — assessed via structured caregiver questionnaire at baseline, 6 weeks, and 12 months;Outcome Time Points Clarification -Day 0 (Baseline Visit): Pre-intervention — This visit includes enrollment, eligibility confirmation, and collection of baseline data (spirometry, IgE testing, skin prick test, and questionnaires: C-ACT, PAQLQ, MAQ, HBM). These assessments serve as the pre-intervention reference. Immediately after data collection, the intervention begins primarily consisting of tailored asthma education and reinforcement of individualized management strategies based on group assignment. 6 Weeks (Mid-point Visit): During intervention — Follow-up assessment to monitor early treatment response, reinforce education, adjust medications if needed, and re-administer selected questionnaires. 12 Months (Final Visit): *Post-intervention* — Final evaluation of asthma control, quality of life, and adherence after sustained treatment. Repeat spirometry and all questionnaires to assess long-term outcomes.

Secondary

MeasureTime frame
Frequency of asthma exacerbations over the 12-month follow-up period ;School absenteeism due to asthma symptoms ;Emergency room visits or hospitalizations for asthma-related events ;Changes in spirometry parameters (FEV1, FVC) between baseline and final visit Medication adherence, assessed via caregiver report and clinic documentation ;Quality of life, measured using a validated pediatric asthma questionnaire

Countries

Nigeria

Contacts

Public ContactCynthia Emeworo

Nurse study coordinator LLA ENUGU

cynthiaifedinma2019@gmail.com2348107095467

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026