Individualizing Treatment for Asthma in Primary Care

NCT06272370 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: PLACER-2021C3-24737-IC
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

This is a patient level randomized trial for teenagers and adults with asthma who will be randomized to four arms - enhance usual care, rescue inhaled corticosteroids, azithromycin and both rescue inhaled corticosteroids and azithromycin. Participants in all arms will be offered access to an online asthma symptom monitoring system.

Conditions

Asthma; Bronchial Diseases; Respiratory Tract Infections; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Immune System Diseases

Keywords

asthma

Outcome Measures

Primary 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.

  Follow up is up to 3 months.

Secondary Outcomes (1)

• Asthma Quality of Life Questionnaire (AQLQ) as Measured by the Juniper Mini Asthma Quality of Life Questionnaire

  Total follow-up period is up to 3 months per participant.

Study Arms (4)

Enhanced Usual Care

OTHER

Participants will be asked to use an online Asthma Symptom Monitoring tool to enhance communication with the medical team as well as self-awareness of their asthma symptoms. There are no "study drugs" in this arm. All 4 arms of the study will use these tools

Other: Asthma Symptom Monitoring online tools

Rescue Inhaled Corticosteroids

ACTIVE COMPARATOR

Participants in this arm will either have budesonide/formoterol (Symbicort) or mometasone/formoterol (Dulera), or a stand-alone ICS (beclomethasone/QVAR, or budesonide/Pulmicort, or fluticasone Flovent HFA, Flovent Diskus, ArmonAir RespiClick, Arnuity Ellipta, or mometasone, Asmanex HFA, Asmanex Twisthaler or ciclesodine Alvesco HFA) added to the participants usual treatment or a combination inhaler of corticosteroid and albuterol (AirSupra) that was recently approved

Drug: Inhaled Steroids

Azithromycin

ACTIVE COMPARATOR

Participants will use azithromycin (Zithromax) 500mg three times a week (10mg.kg for participants under 50Kg) which can be dropped to 250 mg three times a week for dose related side effects

Drug: Azithromycin Pill

Rescue Inhaled Corticosteroids and azithromycin

ACTIVE COMPARATOR

This arm includes both the inhaled corticosteroid comparator and the azithromycin comparator as described in those two arms Participants in this arm will either have budesonide/formoterol (Symbicort) or mometasone/formoterol (Dulera), or a stand-alone ICS (beclomethasone/QVAR, or budesonide/Pulmicort, or fluticasone Flovent HFA, Flovent Diskus, ArmonAir RespiClick, Arnuity Ellipta, or mometasone, Asmanex HFA, Asmanex Twisthaler or ciclesodine Alvesco HFA) added to the participants usual treatment or a combination inhaler of corticosteroid and albuterol (AirSupra) that was recently approved AND Participants will use azithromycin (Zithromax) 500mg three times a week (10mg.kg for participants under 50Kg) which can be dropped to 250 mg three times a week for dose related side effects

Drug: Inhaled Steroids; Drug: Azithromycin Pill

Interventions

Asthma Symptom Monitoring online tools OTHER

All participants will be provided access to the Asthma Symptom Monitoring tools and 3/4's will be randomized to one of the other three arms above

Enhanced Usual Care

Inhaled Steroids DRUG

participants 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

Rescue Inhaled Corticosteroids; Rescue Inhaled Corticosteroids and azithromycin

Azithromycin Pill DRUG

Participants 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

Azithromycin; Rescue Inhaled Corticosteroids and azithromycin

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical asthma diagnosis for at least 1 year;
• years of age;
• A current ACT total score of \<20 OR an exacerbation requiring 72 hours or more of parenteral steroids or a hospitalization of at least 24 hours \> 30 days and \< 365 days prior to enrollment;
• Patients with a coexisting clinical diagnosis of COPD are eligible if they meet any one of the following criteria: (i) Never smoker without secondary lung disease causing airway obstruction. (ii) Current or former smoker with obstruction on PFTs, but normal diffusing capacity of the lungs for carbon monoxide (DLCO) in the past 24 months.

You may not qualify if:

• 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;
• Allergy to macrolides or conditions for which macrolide administration may possibly be hazardous (e.g., acute or chronic hepatitis, cirrhosis, or other liver disease; end-stage renal disease; uncorrected hypokalemia or hypomagnesemia; clinically significant bradycardia; or history of prolonged cardiac repolarization and QT interval or torsades de pointes);
• On daily or every other day oral steroids for any reason;
• Currently on R-ICS or AZ therapy. Individuals on biologics can be enrolled if they have been on a stable dose for \> 6 months and meet the ACT or exacerbation criteria as well as all other criteria.
• On a medication with known risk (i.e., that is associated with prolonged QT and associated with torsades de pointes even when taken as recommended) or possible risk (i.e., can cause prolonged QT but lacks evidence for risk of torsades de pointes when taken as recommended) - Full lists in Appendix 1.
• Specified medications for which close monitoring has been recommended in the setting of macrolide administration (digoxin, warfarin, theophylline, ergotamine or dihydroergotamine, cyclosporine, hexobarbital, phenytoin or nelfinavir).

Sponsors & Collaborators

• DARTNet Institute: lead
• Penn State University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• University of Colorado, Denver: collaborator
• RAND: collaborator
• University of Washington: collaborator
• Rutgers University: collaborator
• University of North Carolina: collaborator
• Brigham and Women's Hospital: collaborator
• Reliant Medical Group: collaborator
• Kelsey Research Foundation: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

DARTNet Insitute

Aurora, Colorado, 80045, United States

Location

Related Publications (5)

• Israel E, Cardet JC, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, Maher NE, Fagan M, Forth VE, Yawn BP, Arias Hernandez P, Kruse JM, Manning BK, Rodriguez-Louis J, Shields JB, Ericson B, Colon-Moya AD, Madison S, Coyne-Beasley T, Hammer GM, Kaplan BM, Rand CS, Robles J, Thompson O, Wechsler ME, Wisnivesky JP, McKee MD, Jariwala SP, Jerschow E, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang KL, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A, Pace WD. Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med. 2022 Apr 21;386(16):1505-1518. doi: 10.1056/NEJMoa2118813. Epub 2022 Feb 26.

  PMID: 35213105 BACKGROUND

• Ray A, Camiolo M, Fitzpatrick A, Gauthier M, Wenzel SE. Are We Meeting the Promise of Endotypes and Precision Medicine in Asthma? Physiol Rev. 2020 Jul 1;100(3):983-1017. doi: 10.1152/physrev.00023.2019. Epub 2020 Jan 9.

  PMID: 31917651 BACKGROUND

• Wenzel SE. Severe Adult Asthmas: Integrating Clinical Features, Biology, and Therapeutics to Improve Outcomes. Am J Respir Crit Care Med. 2021 Apr 1;203(7):809-821. doi: 10.1164/rccm.202009-3631CI.

  PMID: 33326352 BACKGROUND

• Calmes D, Huynen P, Paulus V, Henket M, Guissard F, Moermans C, Louis R, Schleich F. Chronic infection with Chlamydia pneumoniae in asthma: a type-2 low infection related phenotype. Respir Res. 2021 Feb 26;22(1):72. doi: 10.1186/s12931-021-01635-w.

  PMID: 33637072 BACKGROUND

• Global Initiative for Asthma. Global strategy for asthma management and prevention 2023 report. Accessed February 10, 2024. https://ginasthma.org/2023-gina-main-report/

  BACKGROUND

MeSH Terms

Conditions

Asthma; Bronchial Diseases; Respiratory Tract Infections; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Immune System Diseases

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Hypersensitivity, Immediate; Hypersensitivity; Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Limitations and Caveats

We approached the feasibility phase with a focus on testing processes and answering the questions posed by the Patient-centered Outcome Research Institute study reviewers. These were: 1) Could we find eligible people willing to be randomized? 2) Would participants be able to obtain their R-ICS? 3) Would participants use the ASM system? 4) Would participants complete outcome questionnaires? Results from the feasibility study will be used to inform the main study.

Results Point of Contact

• Title: Wilson Pace, MD
• Organization: DARTNet Institute

Wilson.pace@dartnet.info

800-434-0278

Study Officials

• Wilson D Pace, MD

  DARTNet Institute

  PRINCIPAL INVESTIGATOR

• David T Mauger, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: patient randomized trial of three different drug combinations

Study Record Dates

• First Submitted: February 10, 2024
• First Posted: February 22, 2024
• Study Start: February 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)