Community Program for Chronic Respiratory Diseases

(INTERLUNG Trial)

Not yet recruiting at 1 trial location
WC
EM
Overseen ByErika Miller, MHS
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a community health volunteer-led program can improve lung health for people in Bhaktapur, Nepal, who are at risk of chronic respiratory diseases like asthma or COPD. The program, a multi-component respiratory health intervention, focuses on reducing tobacco smoke, air pollution, and respiratory infections while promoting physical activity. Participants are divided into two groups: one receives regular health advice and support, while the other continues with their normal care. Residents of Bhaktapur who often experience coughing, wheezing, or have had asthma or tuberculosis might be a good fit for this study. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for the community health worker-delivered multi-component respiratory health intervention?

Research has shown that programs led by community health workers are generally safe and well-tolerated. Studies have found that these programs help people manage conditions like asthma and COPD without significant side effects. For example, community health workers have successfully improved asthma control and quality of life without major problems. They teach people how to reduce triggers at home, and no serious adverse events have been reported.

This study is in Phase 4, indicating that earlier stages have already tested the treatment for safety. Earlier phases focus heavily on safety, so by the time a study reaches Phase 4, the treatment is generally considered safe. It is now being tested in real-world settings to confirm its benefits and any long-term effects.12345

Why are researchers enthusiastic about this trial?

Researchers are excited about this community health worker-delivered intervention for chronic respiratory diseases because it takes a comprehensive, hands-on approach to improving respiratory health. Unlike standard treatments that may focus on medication and occasional doctor visits, this intervention includes home visits by trained community health workers who provide guidance and tools like HEPA air purifiers and vacuum cleaners to reduce environmental risk factors. It also emphasizes preventive measures such as tobacco cessation, mask usage during high pollution or illness seasons, and vaccinations against flu and pneumonia. This holistic approach aims not just to treat symptoms but to enhance overall respiratory health by addressing environmental and behavioral factors.

What evidence suggests that this community health program is effective for improving lung health in chronic respiratory diseases?

Research shows that programs led by community health workers can improve lung health. In this trial, participants in the intervention arm will receive a multi-component intervention delivered by community health workers. This intervention aims to reduce environmental and infectious respiratory risk factors and promote healthy behaviors. Studies have found that such programs enhance asthma management by improving communication between families and healthcare providers. Participants often experience significant improvements in asthma control, with benefits continuing even after the program ends. Evidence also suggests that community health workers can help reduce diseases like chronic obstructive pulmonary disease (COPD). This approach effectively manages breathing problems by encouraging healthier habits and reducing risk factors.13678

Who Is on the Research Team?

WC

William Checkley, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for people aged 9 or older living in Bhaktapur, Nepal, who have reduced lung function and at least one risk factor for breathing problems (like cough, wheezing, past TB, asthma diagnosis, smoking history, or exposure to dust/smoke). Participants must be willing to attend regular visits over about 40 months.

Inclusion Criteria

Willing to participate in study assessments and follow-up visits during the 40-month study period
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
See 3 more

Exclusion Criteria

Medical condition that precludes safe performance of spirometry
Plans to move out of the study area during the follow-up period
I do not have a current respiratory illness that affects my breathing tests.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment including spirometry, questionnaires, and accelerometry

1 visit
1 visit (in-person)

Intervention/Control

Participants receive either the multi-component intervention or usual care

40 months
11 visits (in-person) every 4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

The study tests if a program led by community health workers—focusing on reducing smoke and pollution exposure, preventing infections with vaccines/masks/handwashing, and promoting safe physical activity—can improve lung health compared to usual care. Participants are randomly assigned to the intervention or control group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention
Group II: Usual care (control) armActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Trials
294
Recruited
1,233,000+

Medstar Health Research Institute

Collaborator

Trials
202
Recruited
187,000+

Tribhuvan University

Collaborator

Trials
2
Recruited
190+

Georgetown University

Collaborator

Trials
355
Recruited
142,000+

Tribhuvan University, Nepal

Collaborator

Trials
26
Recruited
46,800+

Citations

Community Health Workers' Role in Supporting Pediatric ...

CHW-led interventions can assist in decreasing asthma disparities by 1) enhancing asthma management through improved communication between families, health care ...

Outcomes of a Remote Multi-Component Asthma ...

Conclusion: Findings demonstrate positive outcomes of an asthma program delivered remotely by a CBO. They add to the evidence regarding CBO ...

Community Health Worker Asthma Interventions for Children ...

Both intervention groups showed significant improvement in asthma control scores over time. Asthma control was maintained after interventions ended.

Community Health Workers: Delivering Home-Based ...

74 The results from the intervention suggest that home-based asthma programs are likely to be more successful with a clear connection to a clinical provider. In ...

Role of Community Health Workers in Chronic Obstructive ...

The authors concluded that a CHW-based intervention to support management of acute exacerbations of COPD did not result in any significant ...

The INTERvening for LUNG Health Trial (INTERLUNG)

This research study is being done to find out whether a community health volunteer-delivered, multi-component program can improve lung ...

Community Health Workers at Scale In New York City

viii Research shows that. CHW-led interventions significantly improve chronic disease outcomesix,x and contribute to increased self- efficacy, medication ...

Community Health Workers Linking Clinics and Schools ...

This randomized clinical trial investigates if the participation of community health workers in an intervention to connect home, school, ...