The INTERvening for LUNG Health Trial

NCT07540000 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: IRB00548883R01ES037151
• Study Type: interventional
• Target: 800
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Spirometry

Keywords

Tobacco Prevention; Air Pollution; Physical Activity; Behavioral Intervention; Human-Centered Design; Infectious Risk

Outcome Measures

Primary Outcomes (1)

• Pre-bronchodilator FEV₁ Z-score at 40 months

  Mean pre-bronchodilator FEV₁ Z-score measured by spirometry using Global Lung Function Initiative reference equations. The primary analysis will compare mean values between intervention and control groups at the end of follow-up. Lung function will be expressed as Global Lung Function Initiative (GLI) z-scores. A Z-score of 0 represents the population mean.Values below 0 indicate lower lung function and values above 0 indicate higher lung function. The study is powered to detect a difference of 0.25 standard deviations between arms.

  40 months

Secondary Outcomes (4)

• Pre-bronchodilator FVC Z-score

  40 months

• Pre-bronchodilator FEV₁/FVC Z-score

  40 months

• Post-bronchodilator Spirometry Z-scores

  40 months

• Respiratory Health-Related Quality of Life

  40 months

Other Outcomes (1)

• Program Sustainability Assessment Tool

  40 months

Study Arms (2)

Usual care (control) arm

NO INTERVENTION

Participants randomized to the usual care (control) arm will continue routine healthcare and daily practices and will not receive the study intervention during the 40-month follow-up period. Control participants will complete the same schedule of research assessments as the intervention arm, including spirometry, questionnaires, accelerometry, and other study measurements conducted at baseline and every four months. The participant will not receive community health worker visits, vaccines facilitated through the study, air purifiers, vacuum cleaners, masks, or behavioral counseling during the trial. At the conclusion of the study, control households will receive educational materials and will be offered an air purifier and vacuum cleaner.

Intervention

EXPERIMENTAL

Participants randomized to the intervention arm will receive a community health worker-delivered, multi-component intervention designed to reduce environmental and infectious respiratory risk factors and promote healthy behaviors over a 40-month follow-up period. Components include tobacco cessation counseling for participants who use tobacco; use of N95/KN95 masks during periods of high ambient air pollution; use of surgical masks and handwashing during household respiratory illness or viral seasons; provision and use of a HEPA air purifier with periodic filter replacement and a HEPA-filter vacuum cleaner; promotion of regular physical activity through goal setting and self-monitoring; facilitation of annual influenza vaccination for household members; and pneumococcal conjugate vaccination (PCV20) for eligible participants. These components are reinforced through regular home visits by trained community health volunteers.

Behavioral: Community health worker-delivered multi-component respiratory health intervention

Interventions

Community health worker-delivered multi-component respiratory health intervention BEHAVIORAL

Participants receive a community health worker-delivered, multi-component intervention designed to reduce environmental and infectious respiratory risk factors and promote healthy behaviors over 40 months. Components include tobacco cessation counseling for participants who use tobacco; use of N95/KN95 masks during periods of high ambient air pollution; use of surgical masks and handwashing during household respiratory illness or viral seasons; provision and use of a HEPA air purifier with filter replacement and a HEPA-filter vacuum cleaner; promotion of regular physical activity through goal setting and self-monitoring; facilitation of annual influenza vaccination for household members; and pneumococcal conjugate vaccination (PCV20) for eligible participants. Intervention activities are reinforced through regular home visits by trained community health volunteers.

Also known as: INTERLUNG intervention, Multi-component chronic respiratory disease prevention program

Intervention

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Medstar Health Research Institute: collaborator
• Georgetown University: collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator
• Tribhuvan University: collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Tribhuvan University

Maharajgunj, Kathmandu, Nepal

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• William Checkley, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Checkley, MD, PhD

CONTACT

+1 443-287-4587; wcheckl1@jhmi.edu

Erika Miller, MHS

CONTACT

+1 443-287-4235; emille76@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: De-identified individual participant data and supporting documents will become available beginning 12 months after publication of the primary study results or completion of the study, whichever occurs first. Data will remain available for at least 5 years after publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by the study investigators and the Johns Hopkins data access committee will be able to access the data. Requests must include a brief research proposal and a data use agreement. Data will be shared in de-identified form through a secure data repository or controlled-access data transfer consistent with NIH data sharing policies.

Locations

US (1); NE (1)