The INTERvening for LUNG Health Trial

Starting soon · Phase 4

Conditions studied: Spirometry

In brief

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.

Key facts

Study ID

NCT07540000

Run by

Johns Hopkins University

People needed

800

Starts

2026-08-10

Expected to finish

2030-07-01

Last updated by the study team

2026-07-13

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 informed consent or assent.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States
• Tribhuvan University — Maharajgunj, Kathmandu, Nepal

Full record on ClinicalTrials.gov

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