NCT07069192

Brief Summary

This study evaluates the effect of passive smoke exposure on childhood asthma and the role of structured counseling in reducing SHS exposure and improving asthma control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 7, 2025

Last Update Submit

July 16, 2025

Conditions

Keywords

Asthma.Passive Smoke Exposure,Secondhand Smoke,Counsel Intervention,Childhood Asthma,Asthma Control Test,Caregiver Education

Outcome Measures

Primary Outcomes (1)

  • Asthma control test (ACT) Score Improvement

    Change in ACT Score from baseline to 3 months after intervention. ACT score of 19 is considered as normal Asthma control, less then 19 is considered as poor Asthma control and more than 19 ACT score is considered as good Asthma control

    3 months

Study Arms (2)

Control

NO INTERVENTION

usual care without counselling

Counselling

EXPERIMENTAL

Counselling

Behavioral: Counselling

Interventions

CounsellingBEHAVIORAL

Received structured caregiver counseling - weekly sessions for 1 month and biweekly for the next 2 months.

Counselling

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed Asthma, Passive smoke exposure

You may not qualify if:

  • Comorbidity, sever asthma requiring hospitalisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital, Rawalpindi

Rawalpindi, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Asthma

Interventions

Counseling

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The primary purpose is to offer practical insights into reducing the burden of childhood asthma by fusing exposure reduction techniques with asthma management education. It is anticipated that the results will guide evidence-based policy and public health campaigns to lower exposure to SHS, improve asthma outcomes, and improve the lives of children with the condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Public health Officer

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

January 1, 2025

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Not Required

Locations