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Radon Asthma Intervention Trial

NCT ID: NCT06706336

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2030-04-01

Brief Summary

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To determine if radon mitigation can improve asthma

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active Radon Mitigation

Active radon mitigation system

Group Type ACTIVE_COMPARATOR

radon mitigation system

Intervention Type OTHER

standard radon mitigation system used to reduce radon in homes

Inactive radon mitigation system control( sham)

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

Group Type SHAM_COMPARATOR

Sham (No Treatment)

Intervention Type OTHER

inactive radon mitigation system

Interventions

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radon mitigation system

standard radon mitigation system used to reduce radon in homes

Intervention Type OTHER

Sham (No Treatment)

inactive radon mitigation system

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wanda Phipatanakul

S Jean Emans, MD Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wanda Phipatanakul

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Central Contacts

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Wanda Phipatanakul

Role: CONTACT

Phone: 857-218-5336

Email: [email protected]

Other Identifiers

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P00050180

Identifier Type: -

Identifier Source: org_study_id