Indoor Air Quality Asthma Study: The Effect of Indoor Air Quality and Mitigation of Same on Persistent Asthma

NCT05843045 | Unknown

• 1 other identifier: 22-039
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to determine whether continuous sensing, control and mitigation of home indoor air quality influences the frequency of asthma related symptoms, as measured by Serum IgE, Spirometry with exhaled Nitric Oxide, missed school and workdays, need for pharmacologic intervention (albuterol, oral steroids), frequency of sick visits to pulmonologist or primary care provider (PCP), urgent care / emergency department visits, and hospitalizations

Conditions

Persistent Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma Control Test questionnaire

  Monthly Asthma Control Test by History. Possible scores ranging from 0 (worst control)-27 (best control) for patients ages 6-11 or 0 (worst control)- 25 (best control) for patients ages 12-16.

  Through study completion, approximately 2 years

Secondary Outcomes (13)

• Number of asthma related visits to Primary Care Physician, Emergency Department or Urgent Care

  Through study completion, approximately 2 years

• Number of missed school and work days

  Through study completion, approximately 2 years

• Frequency of asthma Medication Use

  Through study completion, approximately 2 years

• Spirometry with exhaled nitric oxide

  Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105

• Physical examination

  Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105

Study Arms (2)

Pre-mitigation

NO INTERVENTION

Information will be collected from participants about their health status and asthma symptoms. Information about the air quality inside the participants' homes will also be collected.

Indoor Air Quality Mitigation

EXPERIMENTAL

Indoor air quality mitigation strategies of a smart home thermostat, smart bath fan switch, and a high-quality furnace filter will be employed within the participants' homes. Information will continue to be collected about participants' health status and asthma symptoms as well as the air quality inside their homes.

Device: Indoor Air Quality Mitigation

Interventions

Indoor Air Quality Mitigation DEVICE

Mitigation of indoor air quality with use of smart thermostat, smart bath fan control, and high quality furnace filters

Also known as: Sensi Touch Smart Thermostat, Enbrighten Z-Wave Switch, 3M Filtrete MPR 2800 Ultrafine Particle Reduction Air Filters

Indoor Air Quality Mitigation

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child aged 5.0-15.9 years at the time of informed consent with mild, moderate, or severe persistent asthma diagnosis. In addition, participants
• Agree to attend visits as outlined by protocol
• Agree to respond to Asthma Control Test (ACT) and asthma control questions as outlined in protocol by telephone call, text, or email.
• Are willing to comply with asthma treatment plan prescribed by physician.
• Are willing to practice an acceptable form of birth control to avoid pregnancy. Acceptable forms of birth control include: true abstinence, male or female condom with or without spermicide, female barrier contraception (such as diaphragm, cervical cap, or sponge) with spermicide, continuous use of an intrauterine device throughout the study, hormonal contraceptives (including oral, patch, implanted, or injected), if used consistently and correctly throughout the study.
• Reside in single-family dwellings and must either be homeowners or have written permission from their landlords to participate in the study.
• In order to participate in the study, homes of participants must
• have working ducted forced air HVAC systems
• a 4-wire thermostat that is determined by Emerson technician to be capable of communicating with Sensi Touch Smart Thermostat
• a bathroom fan switch with neutral wire and wall plate, controlling a bathroom fan that is vented to the outdoors
• access to the internet with a modem or router.
• A smartphone capable of pairing with the Atmotube Pro wearable sensor

Sponsors & Collaborators

• Dayton Children's Hospital: lead
• Cairify LLC: collaborator
• Copeland LP: collaborator

Study Sites (1)

Dayton Childrens Hospital

Dayton, Ohio, 45404, United States

Location

Study Officials

• Daniel A. Evans, MD

  Dayton Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All participants, care providers, and investigators will be blinded to the indoor air quality data as it is collected and the responses of the indoor air quality to mitigation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Pulmonary Medicine at Dayton Children's Hospital

Model Details: The study will consist of two phases with each participant acting as their own control. Data will be collected from participants and their homes for approximately 1 year without mitigation and compared to a second period of approximately 1 year with mitigation.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: May 6, 2023
• Study Start: August 18, 2023
• Primary Completion: August 31, 2025
• Study Completion: January 12, 2026
• Last Updated: January 8, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)