Corticosteroids for Asthma

(AirPATH Trial)

Recruiting at 1 trial location

Overseen By Yonni Friedlander, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: McMaster University

Must not be taking: Oral corticosteroids, Biologic therapy

Disqualifiers: Current smoker, Pregnant, Non-English, 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: 5

242 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of corticosteroids, both inhaled and oral, for individuals with asthma that doesn't improve with regular inhalers. The researchers aim to determine if structural issues in the airways, which can block medication, reduce the effectiveness of inhalers, while oral treatments might still be effective. Participants will begin with a higher dose of inhaled medication and switch to oral if necessary. This trial suits adults diagnosed with asthma who continue to experience frequent symptoms despite treatment. As a Phase 4 trial, this research helps clarify how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used oral corticosteroids in the past month or biologic therapy in the past six months.

What is the safety track record for these treatments?

Previous studies found no extra risk with low doses of inhaled corticosteroids (ICS). However, higher doses were linked to increased risks, such as heart problems and pneumonia. For most issues, the number of people needing treatment for one person to experience harm ranged from 220 to 570.

Oral corticosteroids (OCS) are often used for asthma but can have significant side effects. They are usually given in short bursts and help reduce asthma flare-ups within a week. However, they can cause more severe side effects because they affect the whole body. Despite these risks, they remain commonly used, especially for people with severe asthma.

Both treatments carry risks, but understanding their safety helps participants make informed decisions about joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this approach to treating uncontrolled eosinophilic asthma because it focuses on optimizing and intensifying existing corticosteroid treatments in a strategic way. Unlike the standard of care which may include stable doses of inhaled corticosteroids or periodic oral corticosteroids, this method involves doubling the inhaled corticosteroid dose initially, with the option to add a short course of oral corticosteroids if asthma remains uncontrolled. This stepwise strategy aims to tailor treatment to patient response, potentially leading to better asthma control and fewer side effects than using oral corticosteroids as a first-line approach.

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

Research shows that inhaled corticosteroids (ICS), which participants in this trial may receive, reduce swelling in the airways of people with asthma. This reduction can lead to better asthma control and an improved quality of life. Studies have found that asthma symptoms improve significantly when patients use ICS as directed. However, some people may not follow their prescribed dosage, reducing the treatment's effectiveness.

In this trial, participants with uncontrolled eosinophilic asthma may also receive oral corticosteroids (OCS) if their asthma remains uncontrolled after an increased ICS dose. OCS effectively reduce swelling in severe asthma cases, especially in those with eosinophilic asthma, a type of asthma with high levels of a certain white blood cell. Research suggests that many patients can significantly reduce their need for OCS, and some can even stop using them completely after treatment. This reduction can help lessen the side effects linked to long-term steroid use. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for asthma patients who don't get better with regular inhaled meds. It's likely because the meds can't reach all parts of their lungs due to airway issues like narrowing or mucus. To join, they need a detailed lung scan using MRI or CT.

Inclusion Criteria

Able and willing to provide written informed consent

Able and willing to comply with the study protocol

ACQ ≥1.5 during the screening period

Exclusion Criteria

Non-English speaking

Unable to undergo MRI due to implanted devices or metal in body, severe claustrophobia, or other conditions preventing MRI performance.

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Phase I Treatment

Participants receive a doubling of their current ICS dose for 12 weeks

12 weeks

3 visits (in-person)

Phase II Treatment

Participants receive add-on oral prednisone for one week

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inhaled corticosteroid (ICS)
• Oral Corticosteroid (OCS)

Trial Overview The study tests if abnormal airways affect how well inhaled and oral asthma meds work. Using advanced imaging (MRI/CT), researchers will see if these structural problems make inhaled drugs less effective compared to oral ones.

How Is the Trial Designed?

Group I: Uncontrolled eosinophilic asthma Experimental Treatment 2 Interventions

In Phase I, participants will receive a doubling of their current ICS dose. If their asthma remains uncontrolled, they will receive an OCS burst in phase II.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8289909/

Dynamics of inhaled corticosteroid use are associated with ... Inhaled corticosteroids (ICS) suppress eosinophilic airway inflammation in asthma, but patients may not adhere to prescribed use.

2. archbronconeumol.org archbronconeumol.org/es-inhaled-corticosteroid-reduction-effects-on-avance-S0300289625002996

Inhaled Corticosteroid Reduction Effects on Asthma ... The use of LAMA was reduced 19% (Table 2). Two years after initiating benralizumab treatment, 56% (n=14) of patients had reduced ICS doses to ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(23)02284-5/fulltext

Reduction of daily maintenance inhaled corticosteroids in ... Our key finding is that 92% of patients were able to successfully reduce their high-dose ICS, with more than 60% reducing to anti-inflammatory ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1081120621012199

A real-world study of inhaled corticosteroid use in patients ... The results of this real-world study suggest that reduction in ICS dose or ICS discontinuation is achievable for some patients receiving mepolizumab.

5. bmjopen.bmj.com bmjopen.bmj.com/content/7/11/e018186

Effectiveness of inhaled corticosteroids in real life on ... There was a significant improvement in asthma control, asthma quality of life and airway hyper-responsiveness to methacholine by more than one doubling dilution ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11755353/

What Harm Are We Doing to Our Patients with Asthma by ... The use of medium to high doses of ICSs significantly elevated the risk for cardiovascular events, pulmonary embolism, and hospitalization for pneumonia.

7. jwatch.org jwatch.org/na58313/2025/01/23/how-safe-are-inhaled-corticosteroids-patients-with-asthma

How Safe Are Inhaled Corticosteroids for Patients with ... No excess risk was seen with low-dose ICS. Absolute event numbers were small, and numbers needed to harm (NNH) were 220 to 570 for most outcomes ...

8. annallergy.org annallergy.org/article/S1081-1206(20)30234-9/fulltext

Relative efficacy and safety of inhaled corticosteroids in ... Overall, a high starting dose of ICSs had no additional clinical benefit in 3 of the 4 efficacy parameters compared with low or moderate ICS ...

9. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-review-finds-no-significant-increase-risk-serious-asthma-outcomes

No significant increase in serious asthma outcomes with ... The results of all trials showed that the use of LABA with ICS does not significantly increase the risk of serious asthma outcomes compared to ICS alone.