Inhaled Corticosteroids + Azithromycin for Asthma

(iTREAT-PC Trial)

Recruiting at 12 trial locations

Overseen By Brian K Manning, MPH

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: DARTNet Institute

Must be taking: Inhaled corticosteroids

Must not be taking: Oral steroids, R-ICS, antibiotics

Disqualifiers: Cancer, Liver disease, Heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

3200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to treat asthma by comparing different approaches to using inhaled steroids and azithromycin, an antibiotic. It examines how these treatments work alone and together to manage asthma symptoms and reduce flare-ups. Individuals who have had asthma for at least a year and currently use inhaled steroids, yet still experience frequent symptoms or serious flare-ups, might be suitable candidates for this trial. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research seeks to understand how it benefits more patients.

Do I have to stop taking my current medications to join the trial?

The trial does not specify that you must stop taking your current medications, but if you are on certain antibiotics or medications that interact with azithromycin, you may need to stop them or undergo additional monitoring. If you're on antibiotics for less than 30 days, you can join after stopping them for 72 hours.

What is the safety track record for these treatments?

Past studies have shown that inhaled corticosteroids (ICS), commonly used to treat asthma, are generally safe at low doses. Research indicates that low-dose ICS does not significantly increase the risk of serious side effects. However, moderate to high doses may slightly raise the risk of heart problems and pneumonia.

Studies have indicated that azithromycin is well-tolerated by people with asthma. Participants in these trials did not experience more side effects, such as stomach issues or skin problems, when taking azithromycin.

Although the combination of inhaled corticosteroids and azithromycin has not been extensively studied, both have shown safety when used individually. This suggests they might be safe to use together, although further research would be beneficial to confirm this. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of inhaled corticosteroids (ICS) and azithromycin for asthma because it explores a potentially enhanced approach to managing symptoms. While standard asthma treatments often rely on inhaled corticosteroids for maintenance and short-acting bronchodilators for relief, this trial investigates the use of ICS as part of rescue therapy, which could offer more immediate symptom control. Additionally, azithromycin, an antibiotic typically used to fight infections, is being considered for its anti-inflammatory properties, which might provide further benefit beyond typical asthma medications. This combination aims to improve asthma management by reducing inflammation and providing quick relief, potentially leading to better overall control of asthma symptoms.

What evidence suggests that this trial's treatments could be effective for asthma?

Research has shown that inhaled corticosteroids (ICS) effectively reduce asthma symptoms and lower the risk of severe asthma attacks. Regular use of ICS can cut the number of these attacks by more than half. In this trial, some participants will receive ICS as part of rescue therapy. Azithromycin, an antibiotic, also reduces asthma flare-ups and improves the quality of life for people with severe asthma. Another group in this trial will receive Azithromycin alone. When ICS and Azithromycin are used together, as in one of the trial arms, they significantly reduce severe asthma attacks compared to using quick-relief inhalers alone. This combination offers a promising way to better control asthma symptoms. ^{2 4 6 7 8}

Who Is on the Research Team?

Wilson D Pace, MD, FAAFP

Principal Investigator

DARTNet Institute

Dave Mauger, PhD

Principal Investigator

Penn State University

Are You a Good Fit for This Trial?

This trial is for individuals with persistent asthma. Participants should be currently receiving primary care and willing to try new approaches to reduce asthma exacerbations (AEX). Specific eligibility criteria are not provided, but typically participants must meet certain health conditions.

Inclusion Criteria

I have been diagnosed with asthma for at least a year.

I am prescribed an inhaler for regular or as-needed control, not just for quick relief.

My asthma is not well-controlled, or I've had a severe flare-up needing steroids or hospitalization in the last year.

Exclusion Criteria

Another family member living in the same household already enrolled in study

Life expectancy <1 year

Allergy to macrolides or conditions for which macrolide administration may possibly be hazardous

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Rescue-Inhaled Corticosteroids (R-ICS), azithromycin, or a combination of both, with home monitoring of asthma symptoms

12 months

Regular home monitoring and online communication

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on asthma exacerbations and control

4 months

Open-label extension (optional)

Participants in the azithromycin arms may opt into up to 12 additional months of follow-up after stopping azithromycin

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Azithromycin
• Inhaled corticosteroid (ICS)

Trial Overview The study compares two treatments: Rescue-Inhaled Corticosteroids (R-ICS) used during an asthma attack, and Azithromycin as a preventive therapy. It will evaluate these treatments both separately and together, using a web-based application for symptom monitoring.

How Is the Trial Designed?

Group I: Enhanced Usual Care Experimental Treatment 1 Intervention

Participants will be asked to use an online Asthma Symptom Monitoring (ASM) tool to enhance communication with the medical team as well as self-awareness of their asthma symptoms. There are no "study drugs" in this intervention.

Group II: Inhaled corticosteroids as part of rescue therapy (R-ICS) Active Control 2 Interventions

Maintenance And Reliever Therapy (MART), or Patient Activated Reliever Triggered Inhaled Corticosteroids (PARTICS) - this includes budesonide-albuterol (AirSupra)

Group III: Azithromycin (AZ) Active Control 2 Interventions

Azithromycin - 500mg three times per week. Can be reduced to 250 mg three times per week for side effects.

Group IV: Inhaled corticosteroids as part of rescue therapy (R-ICS) + Azithromycin Active Control 3 Interventions

R-ICS either as MART therapy or PARTICS + Azithromycin

Who Is Running the Clinical Trial?

DARTNet Institute

Lead Sponsor

Trials

5

Recruited

13,700+

Reliant Medical Group

Collaborator

Trials

7

Recruited

78,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

RAND

Collaborator

Trials

145

Recruited

617,000+

AdventHealth

Collaborator

Trials

118

Recruited

31,800+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Kelsey Research Foundation

Collaborator

Trials

6

Recruited

1,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6926362/

Efficacy of azithromycin in severe asthma from the ... Long-term, low-dose azithromycin reduced asthma exacerbations and improved the quality of life in patients with severe asthma, regardless of how ...

2. journal.chestnet.org journal.chestnet.org/article/S0012-3692(24)00284-8/fulltext

Effect of Azithromycin on Asthma Remission in Adults With ... In this study, adults with persistent symptomatic asthma achieved a higher remission rate when treated with azithromycin. Remission on treatment ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0012369224002848

Effect of Azithromycin on Asthma Remission in Adults With ... In this study, adults with persistent symptomatic asthma achieved a higher remission rate when treated with azithromycin. Remission on treatment may be an ...

4. journals.lww.com journals.lww.com/ebp/fulltext/2019/07000/does_the_addition_of_azithromycin_improve_outcomes.1.aspx

Does the addition of azithromycin improve outcomes in the... There was a significant shortening of the asthma-like episode in the azithromycin group compared with placebo (3.4 vs 7.7 days; percent reduction, 63%; 95% CI, ...

5. publications.ersnet.org publications.ersnet.org/content/erj/54/5/1901381

Does maintenance azithromycin reduce asthma ... Azithromycin was effective at reducing the overall rate of exacerbations in both eosinophilic and noneosinophilic asthma. However, different definitions of ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S221253452400008X

Efficacy and safety of macrolide therapy for adult asthma Additional treatment with azithromycin did not increase adverse events including gastrointestinal and skin symptoms in pediatric asthma in the intervention ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6378181/

The efficacy and safety of azithromycin in asthma These findings demonstrate no beneficial clinical outcome of azithromycin in asthma control, and we propose that further prospective cohorts are warranted.

8. severeasthma.org.au severeasthma.org.au/azithromycin/

Azithromycin for Severe Asthma Safety profile. In clinical trials assessing azithromycin treatment in people with severe asthma, treatment was generally well tolerated (2). ...