A Phase 4 interventional study of Community health worker-delivered multi-component respiratory health intervention in Spirometry, sponsored by Johns Hopkins University. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Johns Hopkins University · Phase 4, Interventional, and Prevention
Among 22 studies in Motor Activity by Johns Hopkins University — 4 open to participants now, 5 under way, none of them phase 3. Motor Activity · Johns Hopkins University.
Among the 22 studies in Motor Activity by Johns Hopkins University, this one is the 2nd largest by planned enrollment of the 20 interventional ones, is one of 2 that started in 2026, is the only one in phase 4, and was the 22nd registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 800 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →4 of the 22 studies in Motor Activity by Johns Hopkins University are open now, in 2 countries. Each count lists the studies.
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 9 Years and older · all sexes · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2026.
Median enrollment 79 across the 20 interventional studies, 605 across the 2 observational. Of the 16 that completed or were terminated, 5 (31%) have results posted.
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
2 of the studies in Motor Activity by Johns Hopkins University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05611918Johns Hopkins UniversityREpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study | 2026-12-31 |
| NCT06364644Johns Hopkins UniversityUnderstanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure | 2027-09 |
Among the 22 studies in Motor Activity by Johns Hopkins University, from their registry updates:
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.
Chronic respiratory diseases (CRDs), including asthma, chronic obstructive pulmonary disease (COPD), and chronic bronchitis, represent a major global health challenge, accounting for over 455 million cases and 4 million deaths annually, with the greatest burden in low- and middle-income countries (LMICs). INTERvening for LUNG health (INTERLUNG) is a 40-month randomized controlled trial in Bhaktapur, Nepal, aimed at evaluating a multi-component, community health worker (CHW)-driven intervention for CRD prevention, targeting both environmental and infectious risk factors. The intervention integrates tobacco prevention (education, peer support, nicotine replacement therapy, quit lines), reduction of indoor and ambient air pollution (HEPA purifiers, vacuum cleaners, N95 masks for high pollution days), infectious risk mitigation (annual influenza vaccination and a one-time pneumococcal vaccination, surgical mask use during viral seasons or household illness, and handwashing support), and promotion of physical activity. Human-centered design (HCD) workshops and in-depth interviews with community members, healthcare practitioners, government officials, and multilateral organizations conducted in 2025 and early in 2026 informed adaptation to local context, addressing key implementation factors such as partner and community engagement, compatibility, and resource availability. Eight hundred index participants aged 9 years with impaired lung function (10th percentile or lower in FEV1/FVC Z-score) and chronic respiratory symptoms, along with household members, will be randomized to intervention or usual care, with outcomes assessed at 40 months. Clinical outcomes include improvements in lung function (primary outcome) and respiratory health-related quality of life (St. Georges Respiratory Questionnaire); secondary outcomes encompass implementation metrics such as adoption, acceptability, appropriateness, fidelity, and scalability, evaluated through mixed methods including surveys, adherence monitoring, and qualitative interviews. The project leverages a multidisciplinary team with extensive experience in CRD research, implementation science, and community-based interventions in Nepal, and builds on robust infrastructure for population health research and environmental monitoring. By integrating evidence-based strategies for tobacco control, air pollution reduction, vaccination, and physical activity promotion into a scalable CHW-driven model, INTERLUNG addresses critical gaps in CRD prevention and management in LMICs, aligns with global health priorities and Sustainable Development Goals, and provides a framework for future scale-up and policy integration. The anticipated impact includes improved lung function trajectories and quality of life for at-risk populations, enhanced health system capacity for chronic disease management, and generation of actionable data to inform broader implementation of multi-component respiratory health interventions in urban LMIC settings. The intervention is adaptable for both children and adults, reflecting a life-course approach. It also addresses the need for culturally relevant education and training for primary healthcare staff. The inclusion of environmental monitoring and objective adherence measures (e.g., air quality sensors, pedometer logs) will strengthen outcome assessments and inform best practices for future implementation. By focusing on both clinical effectiveness and implementation outcomes, INTERLUNG will provide critical insights into the feasibility, acceptability, and scalability of comprehensive CRD interventions in resource-limited urban settings. The results are expected to inform national and regional policy, support integration into universal health coverage packages, and contribute to the global evidence base for CRD prevention and management in LMICs. Ultimately, INTERLUNG aims to reduce the burden of CRDs, improve respiratory health equity, and advance sustainable health system strengthening in Nepal and similar contexts.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Household members:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
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.
Time frame: 40 months
Pre-bronchodilator FVC Z-score
Mean pre-bronchodilator forced vital capacity (FVC) Z-score measured by spirometry using Global Lung Function Initiative reference equations. 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.
Time frame: 40 months
Pre-bronchodilator FEV₁/FVC Z-score
Mean pre-bronchodilator FEV₁/FVC Z-score measured by spirometry using Global Lung Function Initiative reference equations. 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.
Time frame: 40 months
Post-bronchodilator Spirometry Z-scores
Post-bronchodilator spirometry measurements (FEV1, FVC, and FEV1/FVC Z-scores) obtained 15 minutes after administration of inhaled bronchodilator. 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.
Time frame: 40 months
Respiratory Health-Related Quality of Life
Health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ). Scores range from 0 to 100, with higher scores indicating worse respiratory health status. The minimal clinically important difference for the SGRQ is 4 points.
Time frame: 40 months
Program Sustainability Assessment Tool
The Program Sustainability Assessment Tool (PSAT) score measures the program's capacity for long-term sustainability across domains such as funding stability, partnerships, organizational capacity, evaluation, and strategic planning, with higher scores indicating greater readiness to sustain intervention activities beyond the study period. The Program Sustainability Assessment Tool (PSAT) score ranges from 1 to 7, with higher scores indicating greater capacity of the program to sustain intervention activities over time across domains such as funding stability, partnerships, organizational capacity, evaluation, and strategic planning.
Time frame: 40 months
Plan to share: Yes — De-identified individual participant data underlying the results reported in publications will be shared. Shared data will include baseline characteristics, spirometry measurements, questionnaire responses, environmental exposure measurements, and other study variables necessary to reproduce published analyses. Data will be de-identified in accordance with NIH and institutional data sharing policies to protect participant confidentiality.
Supporting information: Study protocol, Statistical analysis plan, 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2030, 40 months later.
Of 34 phase 4 interventional studies under Motor Activity, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's planned 40 months is above that.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 8, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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