Radon Asthma Intervention Trial (ROME)

Boston Children's Hospital

Status: Not yet enrolling

Conditions: Asthma

Treatments: Other: Sham (No Treatment); Other: radon mitigation system

Study type: Interventional

Funder types: Other

Identifiers

NCT06706336

P00050180

Details and patient eligibility

About

To determine if radon mitigation can improve asthma

Full description

We will conduct a randomized, double-blind, sham controlled trial to investigate the efficacy of radon mitigation in the homes of susceptible individuals to provide evidence for health benefits by improving indoor air quality. The trial will include 180 children with asthma. We will install a standard radon specific mitigation system in the participant's home. Health outcomes will be followed over 48 weeks to determine the outcomes of the intervention versus inactive (sham) control.

Enrollment: 180 estimated patients

Sex: All

Ages: 5 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Have physician-diagnosed asthma at least 1 year prior to the screening visit
2. Have evidence of uncontrolled disease as defined by at least one of the following:

Use of an asthma medication during the prior 12 months, report of asthma symptoms over the prior 12 months (wheezing/whistling in the chest)(3)

OR

One or more asthma-related hospitalization, emergency room visit

OR

Unscheduled clinic or urgent care facility visit resulting in a burst of systemic steroids (3 days or more of prednisone or equivalent; 1 or more doses of dexamethasone) in the previous 12 months

Exclusion Criteria

1. Not residing at the household for at least 5 days a week or family planning to move from the current home within the next twelve months, or homes with active radon mitigation systems (if home uses a HEPA filter air purifier, family must agree to disable the purifier for 28 days prior to randomization).
2. Lung disease, other than asthma, that requires daily medication (inflammatory diseases, chronic lung diseases aside from asthma, congenital cardiopulmonary conditions requiring medication or surgical treatment),
3. Homes with active HEPA filters will be excluded (even though the role of HEPA filters on radon and radon particles s is expected to be minimum and other exposures can be adjust for in the analysis)
4. Cardiovascular disease that requires daily medication, excluding hypertension
5. Taking a beta-blocker
6. Currently receiving unstable level of Immunotherapy (allergy shots)
7. Coordinator/PI judgment
8. Inability to perform lung function testing
9. Intake of abuse drugs or alcohol, have psychiatric disorders or severe mental disability that interferes with answering questions or following instructions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Active Radon Mitigation

Active Comparator group

Description:

Active radon mitigation system

Treatment:

Other: radon mitigation system

Inactive radon mitigation system control( sham)

Sham Comparator group

Description:

Inactive radon mitigation system looks and sounds like active but doesn't reduce radon ( sham)

Treatment:

Other: Sham (No Treatment)