Childhood AsthmaAsthmaNCT07069192
The Invisible Trigger: A Quasi-Experimental Study on the Effect of Passive Smoke Exposure and Counselling Intervention in Childhood Asthma
A study testing Counselling in people with Childhood Asthma and Passive Smoke Exposure, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Childhood Asthma, Passive Smoke Exposure
- What is being tested?
- Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed Asthma, Passive smoke exposure
Who cannot join
- Comorbidity, sever asthma requiring hospitalisation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Fauji Foundation Hospital, Rawalpindi
Rawalpindi, Punjab Province, 44000
About this study
Official title: The Effect of Passive Smoke Exposure and Counselling Intervention in Childhood Asthma
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.
Read the detailed description
A quasi-experimental study conducted at Fauji Foundation Hospital using a pre-post test design. The intervention group received structured caregiver counseling about the dangers of passive smoking and asthma management. The study used ACT scores to assess improvement in asthma control.
- Conditions
- Childhood Asthma, Passive Smoke Exposure
- Being tested
- Counselling
- Keywords
- Asthma., Passive Smoke Exposure,, Secondhand Smoke,, Counsel Intervention,, Childhood Asthma,, Asthma Control Test,, Caregiver Education
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounsellingBehavioural
Received structured caregiver counseling - weekly sessions for 1 month and biweekly for the next 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | usual care without counselling |
| Counselling | Experimental | Counselling Receives: Behavioral: Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Jan 2025
- Primary completion1 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Saeed, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069192
- Sponsor's protocol ID
- FUMCRCT1
- Acronym
- Asthma
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not Required
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Passive Smoke Exposure and Counselling Intervention in Childhood Asthma
- ClinicalTrials.gov ID
- NCT07069192
- Acronym / sponsor ID
- Asthma / FUMCRCT1
- Conditions
- Childhood Asthma, Passive Smoke Exposure
- Keywords
- Asthma., Passive Smoke Exposure,, Secondhand Smoke,, Counsel Intervention,, Childhood Asthma,, Asthma Control Test,, Caregiver Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A quasi-experimental study conducted at Fauji Foundation Hospital using a pre-post test design. The intervention group received structured caregiver counseling about the dangers of passive smoking and asthma management. The study used ACT scores to assess improvement in asthma control.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –usual care without counselling |
| Counselling | Experimental | Behavioral: CounsellingCounselling |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosed Asthma, Passive smoke exposure
Key exclusion criteria (1 listed)
- Comorbidity, sever asthma requiring hospitalisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounsellingReceived structured caregiver counseling - weekly sessions for 1 month and biweekly for the next 2 months. | Behavioural | Counselling |
Primary outcome
Asthma control test (ACT) Score Improvement
Time frame: 3 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No. Not Required
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselling in people with Childhood Asthma and Passive Smoke Exposure, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control test (ACT) Score Improvement (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.