Individualizing Treatment for Asthma in Primary Care

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Design. Current activities consist of a Feasibility study to test all activities prior to the full study. The Feasibility study will involve only 5 centers and each participant will be involved for only 3 months. The study will consist of a four arm, patient level randomized trial (N=125). Comparators: Rescue Inhaled Corticosteroids (R-ICS) versus azithromycin versus R-ICS plus azithromycin versus enhanced usual care patients. All arms will include home monitoring of asthma symptoms using various approaches. R-ICS therapy will consist of a corticosteriod/formoterol inhaler, or a stand-alone ICS inhaler used with usual rescue therapy or when available a combination corticosteroid/albuterol inhaler, the initial azithromycin dose will be 500mg (10mg/Kg) three times a week and may be titrated down to 250mg (10mg/Kg) three times per week for side effects. Exacerbations will be blindly adjudicated. Individuals who experience three exacerbations in \< 12 months in the full study will have their treatments "stepped-up,"unless in the dual treatment arm; control participants going to R-ICS and single therapy participants to dual therapy. In the full study, after a step-up participants will be followed for an additional 12 months. There will be no step-up during the Feasibility phase. Individuals completing either of the azithromycin arms will be offered 6 additional months of follow-up after stopping the azithromycin only.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patient randomized trial of three different drug combinations

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Enhanced Usual Care

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

Group Type OTHER

Asthma Symptom Monitoring online tools

Intervention Type 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

Rescue Inhaled Corticosteroids

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

Group Type ACTIVE_COMPARATOR

Inhaled Steroids

Intervention Type 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

Azithromycin

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

Group Type ACTIVE_COMPARATOR

Azithromycin Pill

Intervention Type 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

Rescue Inhaled Corticosteroids and azithromycin

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

Group Type ACTIVE_COMPARATOR

Inhaled Steroids

Intervention Type 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

Azithromycin Pill

Intervention Type 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

Interventions

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Asthma Symptom Monitoring online tools

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

Intervention Type OTHER

Inhaled Steroids

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

Intervention Type DRUG

Azithromycin Pill

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. A clinical asthma diagnosis for at least 1 year;
2. 12-75 years of age;
3. 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;
5. 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.

Exclusion Criteria

1. 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);
2. No ICS prescribed for the individual (does not have to be using the ICS inhaler);
3. Active treatment for hematological or solid organ cancer other than basal cell or skin squamous cell cancer;
4. 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);
5. On daily or every other day oral steroids for any reason;
6. 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.
7. 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.
8. 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).

Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No