Nepal trial tests community program to prevent lung disease

NCT ID NCT07540000

Prevention Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 7 times

Summary

This study tests whether a program led by community health workers can improve lung health for 800 people in Bhaktapur, Nepal, who are at risk for chronic respiratory diseases. The program includes tobacco cessation counseling, mask use during high pollution, handwashing, and flu vaccines. Participants will be followed for 40 months with breathing tests and activity monitors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: community health worker-delivered multi-component respiratory health program (behavioral intervention)
What this could lead to: If successful, this could show that community-based programs can prevent chronic lung diseases like asthma and COPD in high-risk populations.
What could go wrong: This is a single-site trial in Nepal, so results may not apply elsewhere. The intervention is complex and depends on consistent participation over 40 months.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 informed consent or assent.

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Conditions

The condition(s) this trial relates to.

Motor Activity influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spirometry

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites in 2 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Nepal trial tests community program to prevent lung disease

What the study statuses mean