SpirometryPhase 4INTERLUNGNCT07540000
The INTERvening for LUNG Health Trial
A Phase 4 study testing Community health worker-delivered multi-component respiratory health intervention in people with Spirometry, run by Johns Hopkins University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Spirometry
- What is being tested?
- Community health worker-delivered multi-component respiratory health intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Nov 2026to 1 Jul 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
Johns Hopkins University
Baltimore, Maryland, 21287
William Checkley, MD, PhD, 443-287-4587, wcheckl1@jhmi.edu
Erika Miller, MHS, +1 443-287-4235, emille76@jhmi.edu
Nepal1 site
Tribhuvan University
Maharajgunj, Kathmandu
Arun Sharma, +977-985-1007462, docarunsharma@iom.edu.np
About this study
Official title: The INTERvening for LUNG Health (INTERLUNG) Trial: A Pragmatic Hybrid Implementation-Effectiveness Trial of Community-Based Interventions to Improve Respiratory Health in Bhaktapur, Nepal
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.
Read the detailed description
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.
- Conditions
- Spirometry
- Being tested
- Community health worker-delivered multi-component respiratory health intervention
- Keywords
- Tobacco Prevention, Air Pollution, Physical Activity, Behavioral Intervention, Human-Centered Design, Infectious Risk
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community health worker-delivered multi-component respiratory health interventionBehavioural
Also called INTERLUNG intervention, Multi-component chronic respiratory disease prevention program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community health worker-delivered multi-component respiratory health intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Nov 2026 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpirometryStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Medstar Health Research Institute, Tribhuvan University, Nepal, Georgetown University, National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- William Checkley, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540000
- Sponsor's protocol ID
- IRB00548883
- Other IDs
- R01ES037151
- Acronym
- INTERLUNG
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INTERvening for LUNG Health (INTERLUNG) Trial: A Pragmatic Hybrid Implementation-Effectiveness Trial of Community-Based Interventions to Improve Respiratory Health in Bhaktapur, Nepal
- ClinicalTrials.gov ID
- NCT07540000
- Acronym / sponsor ID
- INTERLUNG / IRB00548883
- Conditions
- Spirometry
- Keywords
- Tobacco Prevention, Air Pollution, Physical Activity, Behavioral Intervention, Human-Centered Design, Infectious Risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Medstar Health Research Institute, Tribhuvan University, Nepal, Georgetown University, National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Community health worker-delivered multi-component respiratory health interventionParticipants 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. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community health worker-delivered multi-component respiratory health interventionAlso: INTERLUNG intervention, Multi-component chronic respiratory disease prevention programParticipants 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. | Behavioural | Intervention |
Primary outcome
Pre-bronchodilator FEV₁ Z-score at 40 months
Time frame: 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.
4 secondary outcomes
Pre-bronchodilator FVC Z-score
Time frame: 40 months
Pre-bronchodilator FEV₁/FVC Z-score
Time frame: 40 months
Post-bronchodilator Spirometry Z-scores
Time frame: 40 months
Respiratory Health-Related Quality of Life
Time frame: 40 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Checkley, MD, PhD principal investigator
Johns Hopkins University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Community health worker-delivered multi-component respiratory health intervention in people with Spirometry, run by Johns Hopkins University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Checkley, MD, PhD (+1 443-287-4587, wcheckl1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-bronchodilator FEV₁ Z-score at 40 months (time frame: 40 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.