search
Back to results

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

Primary Purpose

Persistent Asthma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indoor Air Quality Mitigation
Sponsored by
Dayton Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Asthma

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dayton Childrens HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pre-mitigation

Indoor Air Quality Mitigation

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of asthma related visits to Primary Care Physician, Emergency Department or Urgent Care
Sick Visits due to asthma
Number of missed school and work days
Number of missed school and work days due to asthma symptoms
Frequency of asthma Medication Use
Use of asthma rescue inhaler and systemic steroids
Spirometry with exhaled nitric oxide
measurement of Forced Expiratory Volume in 1 second measured quarterly
Physical examination
head, eyes, ears, nose, throat (HEENT), lungs, cardiovascular, abdominal, neurologic, and musculoskeletal exam by a licensed physician.
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)
Concentration in serum of immunoglobulin E (IgE)
blood test measuring IgE
height
standing height in centimeters without shoes
weight
weight in kilograms without shoes
heart rate
heart beats per minute
respiratory rate
number of breaths per one minute
blood pressure
systolic over diastolic blood pressure measured in mm/Hg
oxygen saturation
percent of hemoglobin saturated by oxygen in blood

Full Information

First Posted
March 6, 2023
Last Updated
August 18, 2023
Sponsor
Dayton Children's Hospital
Collaborators
Cairify LLC, Copeland LP
search

1. Study Identification

Unique Protocol Identification Number
NCT05843045
Brief Title
Indoor Air Quality Asthma Study: The Effect of Indoor Air Quality and Mitigation of Same on Persistent Asthma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dayton Children's Hospital
Collaborators
Cairify LLC, Copeland LP

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-mitigation
Arm Type
No Intervention
Arm Description
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.
Arm Title
Indoor Air Quality Mitigation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Indoor Air Quality Mitigation
Other Intervention Name(s)
Sensi Touch Smart Thermostat, Enbrighten Z-Wave Switch, 3M Filtrete MPR 2800 Ultrafine Particle Reduction Air Filters
Intervention Description
Mitigation of indoor air quality with use of smart thermostat, smart bath fan control, and high quality furnace filters
Primary Outcome Measure Information:
Title
Asthma Control Test questionnaire
Description
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.
Time Frame
Through study completion, approximately 2 years
Secondary Outcome Measure Information:
Title
Number of asthma related visits to Primary Care Physician, Emergency Department or Urgent Care
Description
Sick Visits due to asthma
Time Frame
Through study completion, approximately 2 years
Title
Number of missed school and work days
Description
Number of missed school and work days due to asthma symptoms
Time Frame
Through study completion, approximately 2 years
Title
Frequency of asthma Medication Use
Description
Use of asthma rescue inhaler and systemic steroids
Time Frame
Through study completion, approximately 2 years
Title
Spirometry with exhaled nitric oxide
Description
measurement of Forced Expiratory Volume in 1 second measured quarterly
Time Frame
Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Title
Physical examination
Description
head, eyes, ears, nose, throat (HEENT), lungs, cardiovascular, abdominal, neurologic, and musculoskeletal exam by a licensed physician.
Time Frame
Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Title
Mini Paediatric Asthma Quality of Life Questionnaire (MiniPAQLQ)
Description
Questionnaire assessing quality of life for patients with asthma. Possible scores range from 13 (worst quality of life)- 91 (best quality of life)
Time Frame
Weeks 1, 49, 53, 105
Title
Concentration in serum of immunoglobulin E (IgE)
Description
blood test measuring IgE
Time Frame
Weeks 1, 53, 105
Title
height
Description
standing height in centimeters without shoes
Time Frame
Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Title
weight
Description
weight in kilograms without shoes
Time Frame
Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Title
heart rate
Description
heart beats per minute
Time Frame
Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Title
respiratory rate
Description
number of breaths per one minute
Time Frame
Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Title
blood pressure
Description
systolic over diastolic blood pressure measured in mm/Hg
Time Frame
Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105
Title
oxygen saturation
Description
percent of hemoglobin saturated by oxygen in blood
Time Frame
Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel A. Evans, MD
Phone
9376413440
Email
evansd@childrensdayton.org
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Jones, MSN, RN
Phone
937-641-3693
Email
jonesa11@childrensdayton.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel A. Evans, MD
Organizational Affiliation
Dayton Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dayton Childrens Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Evans, MD
Phone
937-641-3109
Email
evansd@childrensdayton.org
First Name & Middle Initial & Last Name & Degree
Amy Jones, MSN, RN
Phone
937-641-3693
Email
jonesa11@childrensdayton.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs