Radon Asthma Intervention Trial (ROME)

February 8, 2026 updated by: Wanda Phipatanakul, Boston Children's Hospital
To determine if radon mitigation can improve asthma

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Radon Mitigation
Active radon mitigation system
Other: radon mitigation system
standard radon mitigation system used to reduce radon in homes
Sham Comparator: Inactive radon mitigation system control( sham)
Inactive radon mitigation system looks and sounds like active but doesn't reduce radon ( sham)
Other: Sham (No Treatment)
inactive radon mitigation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma symptoms
Time Frame: past 2 weeks
Number of Days With Asthma Symptoms
past 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Wanda Phipatanakul, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Actual)

November 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P00050180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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