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Symptom-driven ICS/LABA Therapy for Adolescent Patients With Asthma Non-adherent to Daily Maintenance Inhalers

Primary Purpose

Asthma in Children, Nonadherence, Medication

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma in Children

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able to understand and provide informed consent. Age 18-75 at the time of study enrollment. Provider diagnosed mild or moderate persistent asthma and prescribed maintenance ICS treatment and as needed SABA for at least 6 months prior to enrollment. Suboptimal adherence to prescribed maintenance ICS therapy defined as missing at least expected 2 ICS refills in the prior 6 months based on examination of pharmacy records or a Medication Adherence Report Scale for Asthma (MARS-A) score <4.5. An Asthma Control Test (ACT) score at enrollment greater than or equal to 12 but less than or equal to 20 indicating partially controlled or moderately uncontrolled asthma. iPhone or Android smartphone with an active data plan and willingness to use the Adherium device. Exclusion Criteria: Relevant comorbid pulmonary diseases including, but not limited to a diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or alpha 1 anti-trypsin deficiency. Current use of a biologic medication or investigational treatment for asthma. History of asthma requiring ICU admission in the last year. Unwillingness to use or pay for an inhaler that is compatible with the Adherium sensor (fluticasone propionate or budesonide/formoterol). Of note, fluticasone and budesonide/formoterol are formulary tier 1-2 for Missouri Medicaid and most commercial insurances and are believed to be equally or less expensive as alternative inhalers for most patients. Any clinically significant abnormalities on physical exam, laboratory testing, or baseline diagnostic testing that the study team believes will make the study unsafe. Patients who do not complete at least 70% of the twice-daily texts during the two weeks after screening.

Sites / Locations

  • Washington University in St. Louis School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

As needed inhaled corticosteroid and long-acting beta-agonist

Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonist

Arm Description

Symptom-driven ICS/LABA treatment strategy

Continue maintenance ICS and SABA therapy

Outcomes

Primary Outcome Measures

Adherence to inhaler strategy delineated using an electronic inhaler sensor
The primary outcome will be adherence with an inhaler management strategy delineated using the Adherium inhaler sensor and smartphone application as compared between groups. Adherence to the treatment strategy for the maintenance ICS inhaler group will be calculated as the proportion of maintenance ICS actuations per prescription recommendation. Adherence for the symptom-based ICS treatment strategy will be calculated as the proportion of ICS/LABA actuations per recommendation based on self-report of symptoms (definition: ICS/LABA inhaler actuation during a day or night period divided by a period wherein a patient identified symptoms as >1 on REDCap-delivered smartphone questionnaire).

Secondary Outcome Measures

Number of asthma exacerbations
Frequency of study-defined asthma exacerbations between groups (adjusted for time on treatment). Asthma exacerbations will be defined as an urgent medical visit for asthma symptoms, prescription of oral corticosteroids for asthma symptoms, or high use of a rescue inhaler (>16 actuations of SABA or >8 actuations of ICS/LABA within 24 hours on two consecutive days as assessed via the Adherium device).
Time to asthma exacerbation
Time to first exacerbation between groups. Asthma exacerbations will be defined as an urgent medical visit for asthma symptoms, prescription of oral corticosteroids for asthma symptoms, or high use of a rescue inhaler (>16 actuations of SABA or >8 actuations of ICS/LABA within 24 hours on two consecutive days as assessed via the Adherium device)
ICS exposure
Converted cumulative dose of ICS between groups.
Adverse and serious adverse events
Occurrence of any severe and non-severe adverse events between groups.
Change in Asthma Control Questionnaire (ACQ)
Change in Asthma Control Questionnaire (ACQ) from baseline to the final study visit.
Change in asthma control test (ACT)
Change in Asthma Control Test (ACT) from baseline to the final study visit.
Change in Asthma Quality of Life Questionnaire (AQLQ)
Change in Asthma Quality of Life Questionnaire (AQLQ) from baseline to the final study visit.
Change in Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire
Change in Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire from baseline to the final study visit.
Change in IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)
Change in IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM) from baseline to the final study visit.
Change in The Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ)
Change in The Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ) from baseline to the final study visit.
Change in Feeling of Satisfaction with Inhaler (FSI-10) questionnaire
Change in Feeling of Satisfaction with Inhaler (FSI-10) questionnaire from baseline to the final study visit.

Full Information

First Posted
January 9, 2023
Last Updated
January 9, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT05689983
Brief Title
Symptom-driven ICS/LABA Therapy for Adolescent Patients With Asthma Non-adherent to Daily Maintenance Inhalers
Official Title
Symptom-driven ICS/LABA Therapy for Adolescent Patients With Asthma Non-adherent to Daily Maintenance Inhalers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Inhaler nonadherence is a common problem that has been estimated to account for approximately 60% of all asthma-related hospitalizations. Unfortunately, prior interventions to improve inhaler nonadherence have shown a lack of long-term success. This study proposes to assess the problem of non-adherence using a D&I research lens while testing a new inhaler approach to potentially ameliorate the detrimental consequences of maintenance inhaler nonadherence.
Detailed Description
While inhaled corticosteroids (ICS) are considered the essential foundation of most asthma therapy, ICS inhaler non-adherence is a notoriously common problem and a significant cause of asthma-related morbidity. Partially acknowledging the problem of non-adherence, international organizations recently made paradigm-shifting recommendations that all patients with mild or mild-to-moderate persistent asthma be considered for symptom-driven ICS-containing inhalers rather than relying on adherence to traditional maintenance ICS inhalers and symptom-driven beta-agonists. With this novel approach, asthma patients are at least exposed to the important anti-inflammatory effects of ICS-containing inhalers when their inhaler is deployed due to symptoms. The proposed study aims to (Aim 1) undertake a pragmatic pilot randomized-controlled trial to evaluate if an inhaler strategy that utilizes symptom-driven ICS inhalers is particularly accepted and beneficial in maintenance ICS inhaler non-adherent adolescent asthma patients, and (Aim 2) use a D&I science conceptual framework to better understand patients' and providers' views of inhaler non-adherence. This study will use an electronic sensor to monitor inhaler adherence and include semi-structured interviews using the Consolidated Framework for Implementation Research (CFIR).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children, Nonadherence, Medication

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomization will occur using a 1:1 ratio with random numbers generated using SAS 9.4
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
As needed inhaled corticosteroid and long-acting beta-agonist
Arm Type
Active Comparator
Arm Description
Symptom-driven ICS/LABA treatment strategy
Arm Title
Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonist
Arm Type
Placebo Comparator
Arm Description
Continue maintenance ICS and SABA therapy
Intervention Type
Drug
Intervention Name(s)
Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA
Intervention Description
In this study, we propose a pragmatic, pilot, open-label trial where we are comparing adherence to different inhaler regimens. Patients who were previously sub-optimally adherent to maintenance ICS inhalers will either continue receiving maintenance ICS inhalers and symptom-driven SABA inhalers or symptom-driven ICS/LABA inhalers only.
Primary Outcome Measure Information:
Title
Adherence to inhaler strategy delineated using an electronic inhaler sensor
Description
The primary outcome will be adherence with an inhaler management strategy delineated using the Adherium inhaler sensor and smartphone application as compared between groups. Adherence to the treatment strategy for the maintenance ICS inhaler group will be calculated as the proportion of maintenance ICS actuations per prescription recommendation. Adherence for the symptom-based ICS treatment strategy will be calculated as the proportion of ICS/LABA actuations per recommendation based on self-report of symptoms (definition: ICS/LABA inhaler actuation during a day or night period divided by a period wherein a patient identified symptoms as >1 on REDCap-delivered smartphone questionnaire).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Number of asthma exacerbations
Description
Frequency of study-defined asthma exacerbations between groups (adjusted for time on treatment). Asthma exacerbations will be defined as an urgent medical visit for asthma symptoms, prescription of oral corticosteroids for asthma symptoms, or high use of a rescue inhaler (>16 actuations of SABA or >8 actuations of ICS/LABA within 24 hours on two consecutive days as assessed via the Adherium device).
Time Frame
24 weeks
Title
Time to asthma exacerbation
Description
Time to first exacerbation between groups. Asthma exacerbations will be defined as an urgent medical visit for asthma symptoms, prescription of oral corticosteroids for asthma symptoms, or high use of a rescue inhaler (>16 actuations of SABA or >8 actuations of ICS/LABA within 24 hours on two consecutive days as assessed via the Adherium device)
Time Frame
24 weeks
Title
ICS exposure
Description
Converted cumulative dose of ICS between groups.
Time Frame
24 weeks
Title
Adverse and serious adverse events
Description
Occurrence of any severe and non-severe adverse events between groups.
Time Frame
24 weeks
Title
Change in Asthma Control Questionnaire (ACQ)
Description
Change in Asthma Control Questionnaire (ACQ) from baseline to the final study visit.
Time Frame
24 weeks
Title
Change in asthma control test (ACT)
Description
Change in Asthma Control Test (ACT) from baseline to the final study visit.
Time Frame
24 weeks
Title
Change in Asthma Quality of Life Questionnaire (AQLQ)
Description
Change in Asthma Quality of Life Questionnaire (AQLQ) from baseline to the final study visit.
Time Frame
24 weeks
Title
Change in Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire
Description
Change in Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire from baseline to the final study visit.
Time Frame
24 weeks
Title
Change in IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)
Description
Change in IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM) from baseline to the final study visit.
Time Frame
24 weeks
Title
Change in The Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ)
Description
Change in The Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ) from baseline to the final study visit.
Time Frame
24 weeks
Title
Change in Feeling of Satisfaction with Inhaler (FSI-10) questionnaire
Description
Change in Feeling of Satisfaction with Inhaler (FSI-10) questionnaire from baseline to the final study visit.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to understand and provide informed consent. Age 18-75 at the time of study enrollment. Provider diagnosed mild or moderate persistent asthma and prescribed maintenance ICS treatment and as needed SABA for at least 6 months prior to enrollment. Suboptimal adherence to prescribed maintenance ICS therapy defined as missing at least expected 2 ICS refills in the prior 6 months based on examination of pharmacy records or a Medication Adherence Report Scale for Asthma (MARS-A) score <4.5. An Asthma Control Test (ACT) score at enrollment greater than or equal to 12 but less than or equal to 20 indicating partially controlled or moderately uncontrolled asthma. iPhone or Android smartphone with an active data plan and willingness to use the Adherium device. Exclusion Criteria: Relevant comorbid pulmonary diseases including, but not limited to a diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or alpha 1 anti-trypsin deficiency. Current use of a biologic medication or investigational treatment for asthma. History of asthma requiring ICU admission in the last year. Unwillingness to use or pay for an inhaler that is compatible with the Adherium sensor (fluticasone propionate or budesonide/formoterol). Of note, fluticasone and budesonide/formoterol are formulary tier 1-2 for Missouri Medicaid and most commercial insurances and are believed to be equally or less expensive as alternative inhalers for most patients. Any clinically significant abnormalities on physical exam, laboratory testing, or baseline diagnostic testing that the study team believes will make the study unsafe. Patients who do not complete at least 70% of the twice-daily texts during the two weeks after screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail Zulich
Phone
314-747-3063
Email
azulich@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tammy Quinones
Phone
314-747-3063
Email
tkoch@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Krings, MD MSc
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy Quinones, RN
Phone
314-747-3063
Email
tquinones@wustl.edu
First Name & Middle Initial & Last Name & Degree
James Krings, MD MSc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Symptom-driven ICS/LABA Therapy for Adolescent Patients With Asthma Non-adherent to Daily Maintenance Inhalers

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