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

Persistent Asthma Clinical Trial

— IAQ  

Official title:

Indoor Air Quality Asthma Study: A Cooperative Study Between Coepland LP, Cairify, and Dayton Children's Hospital to Determine the Effect of Indoor Air Quality and Mitigation of Indoor Air Quality on Persistent Asthma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05843045
• Other study ID #: 22-039
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 18, 2023
• Est. completion date: January 12, 2026

Study information

• Verified date: July 2023
• Source: Dayton Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Participants will be in the research study for approximately 2 years. There will be 11 visits to the clinic for monitoring of asthma symptoms and pulmonary function and 16 interval contacts with research staff made by either telephone or email to monitor asthma symptoms. There will also be 5 visits to participants' homes by technicians from Emerson Climate Technologies and/or an electrician in cooperation with Emerson. During these visits Emerson employees will assess participants' homes to determine if they qualify for the study and install study equipment to monitor air quality for the first half of the study and monitor and mitigate air quality for the second half of the study. At the end of the study, the technicians and/or electrician from Emerson will reset the study equipment or replace participants' original equipment, if that is their wish. Participants will be enrolled in the research study for approximately 2 years. The first year, technicians from the study sponsor will install indoor air quality monitoring equipment in the participants' homes and information about the air quality in their home as well as baseline health and asthma information will be collected. This will be done through continuous sensing via an Atmocube air quality sensor, and a portable air quality sensor, the Atmotube. Beginning in the second half of the study, mitigation strategies of a smart home thermostat, the Sensi Touch Smart Thermostat, a smart bath fan control, the Enbrighten Z-wave Switch, and high quality furnace filter, 3M Filtrete MPR 2800 Ultrafine Particle Reduction Air Filter, will be employed. Information about the participants' asthma, health status, and air quality in the homes will continue to be collected.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: January 12, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Exclusion criteria: Age <5.0 or >15.9 years at the time of informed consent, inability to commit to being in the same home for the length of the study, and/or not meeting the above inclusion criteria.

Related Conditions & MeSH terms

• Asthma
• Persistent Asthma

Intervention

Device:
• Indoor Air Quality Mitigation
Mitigation of indoor air quality with use of smart thermostat, smart bath fan control, and high quality furnace filters

Locations

Country	Name	City	State
United States	Dayton Childrens Hospital	Dayton	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Dayton Children's Hospital	Cairify LLC, Copeland LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of asthma related visits to Primary Care Physician, Emergency Department or Urgent Care	Sick Visits due to asthma	Through study completion, approximately 2 years
Secondary	Number of missed school and work days	Number of missed school and work days due to asthma symptoms	Through study completion, approximately 2 years
Secondary	Frequency of asthma Medication Use	Use of asthma rescue inhaler and systemic steroids	Through study completion, approximately 2 years
Secondary	Spirometry with exhaled nitric oxide	measurement of Forced Expiratory Volume in 1 second measured quarterly	Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Secondary	Physical examination	head, eyes, ears, nose, throat (HEENT), lungs, cardiovascular, abdominal, neurologic, and musculoskeletal exam by a licensed physician.	Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Secondary	Mini Paediatric Asthma Quality of Life Questionnaire (MiniPAQLQ)	Questionnaire assessing quality of life for patients with asthma. Possible scores range from 13 (worst quality of life)- 91 (best quality of life)	Weeks 1, 49, 53, 105
Secondary	Concentration in serum of immunoglobulin E (IgE)	blood test measuring IgE	Weeks 1, 53, 105
Secondary	height	standing height in centimeters without shoes	Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Secondary	weight	weight in kilograms without shoes	Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Secondary	heart rate	heart beats per minute	Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Secondary	respiratory rate	number of breaths per one minute	Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Secondary	blood pressure	systolic over diastolic blood pressure measured in mm/Hg	Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Secondary	oxygen saturation	percent of hemoglobin saturated by oxygen in blood	Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105