Individualizing Treatment for Asthma in Primary Care (Full Study)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age13-75
SponsorDARTNet Institute
About this trial
While asthma therapy is becoming more individualized based on asthma phenotypes, more research is needed to tailor newer therapies to individuals. Inhaled corticosteroid (ICS) medications are the foundation of care for all individuals with persistent asthma. But ICS use is not without possible long term side effects.
This study will compare two currently available approaches to reduce AEX in primary care patients: (1) use of inhaled corticosteroids (ICS) as part of rescue therapy, also known as MART (Maintenance And Reliever Therapy) or PARTICS (Patient Activated Reliever Trigger Inhaled Corticosteriods) therapy - either of these therapies will be called Rescue-Inhaled Corticosteroids or R-ICS pronounced "Ricks," and (2) use of azithromycin (AZ) as a preventive therapy. These treatments will be studied both individually and in combination.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A clinical asthma diagnosis for at least 1 year;
13-75 years of age;
A prescription for an ICS either used regularly, or on an as needed controller, not reliever, schedule - ICS or ICS + LABA or ICS+LABA+LAMA;
A current ACT total score of <20 OR an exacerbation requiring 72 hours or more of systemic steroids or a hospitalization of at least 24 hours > 30 days and < 365 days prior to enrollment;
Disqualifiers
Another family member living in the same household already enrolled in study;
Life expectancy <1 year (operationalized by the question to the patient's asthma care clinician "Would you be surprised if this person died in the next 12 months? If yes - include, if no - exclude);
No ICS prescribed for the individual (does not have to be using the ICS inhaler);
Active treatment for hematological or solid organ cancer other than basal cell or skin squamous cell cancer (if participant is > 12 months out from original therapy and may be on a cancer maintenance drug that is not otherwise contraindicated they are eligible for the study);
Trial design
Design model
Parallel
Treatments tested in this trial
Inhaled corticosteroid (ICS)
DrugParticipants will use either a combination of budesonide/formoterol or mometasone/formoterol as both controller and rescue therapy or a stand alone inhaled steroid (beclomethasone, budesonide, fluticasone, mometasone, ciclesodine) of their choice with their current reliever therapy or be converted to budesonide/albuterol as rescue therapy.
Azithromycin
DrugParticipants will take 500mg of azithromycin three times a week or 10mg/kg if under 50Kg which may be reduced to 250mg/Kg for side effects.
Asthma Symptom Monitoring Web-based Application
Other interventionAll participants will be provided access to the Asthma Symptom Monitoring (ASM) tools. ASM can be integrated with electronic health records (EHR) or used as a stand alone application. Participants will answer 5 questions about their asthma each week. If symptoms are problematic, participants can request a call back from a person on their care team. Participants can view a graph of their data, watch videos, and record peak flows. Clinicians and members of the care team can view data in the EHR (not for stand alone web app).
Treatment groups
3,200 Participants
are divided into 4 treatment groupsGroup A: Inhaled corticosteroids as part of rescue therapy (R-ICS)Active comparator 2 interventions
Group B: Azithromycin (AZ)Active comparator 2 interventions
Group C: Enhanced Usual CareOther 1 intervention
Group D: Inhaled corticosteroids as part of rescue therapy (R-ICS) + AzithromycinActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Rate of Asthma Exacerbations Per Year
The primary outcome, the rate of asthma exacerbations per year, is defined as the number of exacerbations, emergency room visits, or hospitalizations requiring oral or parenteral corticosteroids, per patient per year, monthly through study completion.
Time frame
Follow-up is up to 16 months.Secondary outcomes
1
Asthma Control as Measured by the Asthma Control Test (ACT)
Asthma control represents the degree to which impairment (impact of asthma on patient's daily life) is minimized and the goals of therapy are met. The Asthma Control Test is a participant administered tool for assessing the level of asthma control. Total scores range from 5 to 25, with a score of 20 to 25 indicating well-controlled asthma, a score of 16 to 19 indicating asthma that was not well controlled, and a score of 5 to 15 indicating very poorly controlled asthma. The Asthma Control Test has a score range of 5 to 25 with higher scores indicating better control.
Time frame
Follow-up is up to 16 months.2
Asthma Quality of Life Questionnaire (AQLQ) as Measured by the Juniper Mini Asthma Quality of Life Questionnaire
The Asthma Quality of Life Questionnaire is a participant-administered tool for assessing functional impairment. Total scores range from 1 to 7, with a score of 7=no impairment and 1=maximum impairment.
Time frame
Follow-up is up to 16 months.3
Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma
Defined as days not able to work or go to school because of asthma symptoms OR days not able to carry out usual activities due to asthma.
Time frame
Follow-up is up to 16 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
DARTNet Institute
Lead sponsor
Penn State University
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
University of Colorado, Denver
Collaborator
RAND
Collaborator
University of Washington
Collaborator
University of North Carolina
Collaborator
Reliant Medical Group
Collaborator
Kelsey Research Foundation
Collaborator
University of Kansas
Collaborator
University of Missouri-Columbia
Collaborator
John Peter Smith Health Network
Collaborator
Rutgers University
Collaborator
AdventHealth
Collaborator
Wake Forest University Health Sciences
Collaborator
Source ClinicalTrials.gov