The INTERvening for LUNG Health Trial (NCT07540000) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The INTERvening for LUNG Health Trial
United States, Nepal800 participantsStarted 2026-07-01
Plain-language summary
This research study is being done to find out whether a community health volunteer-delivered, multi-component program can improve lung health for people at risk of chronic respiratory diseases (such as asthma or COPD) in Bhaktapur, Nepal. The program focuses on reducing tobacco smoke exposure, reducing indoor and outdoor air pollution exposure, preventing respiratory infections (including vaccination and mask use during viral seasons), and encouraging safe physical activity. The "index participant" is the main enrolled participant in the household who is randomized to the intervention or control arm.
The participant will be in the study for about 40 months and will have 11 research visits: one at baseline and then every 4 months through month 40. At visits, staff will do breathing tests (spirometry before and after an inhaled medicine), measure exhaled carbon monoxide, check blood pressure, measure height/weight at selected visits, and ask questions about symptoms, smoking, infections, vaccines, and quality of life. The participant will also wear an activity monitor (accelerometer) for 2 weeks at baseline and at follow-up visits. If individual is a household member (not the index participant), the participant may be asked to complete baseline and follow-up assessments every 4 months through month 40, will receive the influenza vaccine and will primarily be asked to use masks and handwashing during household respiratory illness episodes (only if the index participant is randomized to the intervention) and will not be asked to wear an activity monitor. If the participant is in the pilot phase, participation will last about 2 months. the participant will complete baseline procedures and pilot follow-up visits during those 2 months instead of the full 40-month schedule.
Who can participate
Age range
9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Age ≥9 years at enrollment.
* Resident of the Bhaktapur district and member of a household willing to participate in study procedures.
* Pre-bronchodilator FEV1/FVC at or below the 10th percentile (Z-score ≤ -1.28) based on Global Lung Function Initiative reference equations.
* Presence of at least one respiratory risk factor, including:
* usual cough or phlegm, wheezing in the past 12 months, self-reported prior pulmonary tuberculosis, physician-diagnosed asthma, ever smoking, or occupational exposure to dust or smoke.
* Willing and able to provide written informed consent (or assent with parental/guardian permission for participants \<18 years).
* Willing to participate in study assessments and follow-up visits during the 40-month study period.
Exclusion Criteria
* Medical condition that precludes safe performance of spirometry.
* Acute respiratory illness at the time of enrollment that would prevent reliable baseline spirometry testing.
* Plans to move out of the study area during the follow-up period. Inability or unwillingness to comply with study procedures or follow-up visits.
* Any other condition that, in the opinion of the investigators, would interfere with participation or interpretation of study results.
Household members:
* Household members of enrolled index participants may participate in certain assessments and receive selected intervention components if the index participant is randomized to the intervention arm and provides informe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.