ICS/LABA for Asthma Nonadherence

Not currently recruiting at 1 trial location

Overseen By Tammy Quinones

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Washington University School of Medicine

Must be taking: ICS, SABA

Must not be taking: Biologics, Investigational treatments

Disqualifiers: COPD, Cystic fibrosis, ICU history, others

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help people with asthma adhere better to their inhaler routines. It aims to determine if a different inhaler approach can reduce asthma-related issues, particularly for those who frequently miss doses. Participants will either maintain their usual inhaler routine or try a new method using a combination inhaler (Budesonide/Formoterol) only when symptoms appear. This trial suits individuals with mild or moderate asthma who have been skipping inhaler refills and own a smartphone. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to explore this new approach.

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

The trial does not specify if you need to stop taking your current medications. However, you must be willing to use an inhaler compatible with the Adherium sensor, like fluticasone propionate or budesonide/formoterol.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatment under testing, budesonide/formoterol, is generally safe for individuals with mild asthma. Studies have found no new safety issues with this inhaler. In double-blind trials, using budesonide/formoterol as needed reduced the risk of severe asthma attacks.

Additionally, formoterol, a component of this treatment, has been shown to lower the chances of serious asthma problems, resulting in fewer severe asthma issues. Overall, the evidence suggests that this treatment is safe for people with asthma. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for asthma?

Researchers are excited about the treatment strategy involving Budesonide/Formoterol for asthma because it offers a more flexible, symptom-driven approach. Unlike the standard regimen, which typically involves daily maintenance with inhaled corticosteroids and the occasional use of short-acting beta-agonists (SABAs) for relief, this method combines an inhaled corticosteroid (ICS) with a long-acting beta-agonist (LABA) to be used as needed. This could simplify asthma management by letting patients adjust their medication based on symptoms. It may also improve adherence by reducing the number of medications needed daily, potentially leading to better overall control of asthma symptoms.

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

Research shows that the budesonide/formoterol inhaler can help treat asthma. In this trial, one group of participants will use the budesonide/formoterol inhaler as needed. Previous studies have found this approach more effective at preventing asthma symptoms than using albuterol. Another study found that this treatment improved both the quality of life for people with asthma and their lung function. Importantly, using budesonide/formoterol for both regular use and quick relief made it easier for people to adhere to their treatment plan. Overall, the evidence suggests that this inhaler combination could be a promising option for managing asthma effectively. ^{3 6 7 8 9}

Who Is on the Research Team?

James Krings, MD MSc

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for people aged 18-75 with mild or moderate persistent asthma who have been non-adherent to their daily maintenance inhalers, missing at least two expected refills in the past six months. Participants must have partially controlled or moderately uncontrolled asthma and be willing to use a smartphone-connected device.

Inclusion Criteria

My asthma is partially controlled, with an ACT score between 12 and 20.

You have not been taking your prescribed asthma medication regularly, missing at least 2 refills in the past 6 months or scoring less than 4.5 on a medication adherence scale.

I have been diagnosed with persistent asthma and have been on a prescribed asthma treatment plan for at least 6 months.

Exclusion Criteria

I have completed less than 70% of the required texts after screening.

Any clinically significant abnormalities on physical exam, laboratory testing, or baseline diagnostic testing that the study team believes will make the study unsafe.

I have a lung condition like COPD, cystic fibrosis, or alpha 1 anti-trypsin deficiency.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive symptom-driven ICS/LABA treatment strategy or standard therapy for asthma

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Budesonide/Formoterol

Trial Overview The study tests if using budesonide/formoterol only when symptoms occur is as effective as sticking to regular maintenance inhaler therapy combined with symptom-driven SABA. It aims to address the issue of patients not regularly using their prescribed inhalers.

How Is the Trial Designed?

Group I: As needed inhaled corticosteroid and long-acting beta-agonist Active Control 1 Intervention

Symptom-driven ICS/LABA treatment strategy

Group II: Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonist Placebo Group 1 Intervention

Continue maintenance ICS and SABA therapy

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2148237/

Poor adherence with inhaled corticosteroids for asthma The present study found that using a single inhaler containing budesonide and formoterol for both maintenance and relief helped to overcome this problem because ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40956480/

A United Kingdom General Practice Cohort Study Patients who continued initiation treatment for a year without interruption had reduced exacerbation rates with FF/VI versus BUD/FOR.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1901963

Controlled Trial of Budesonide–Formoterol as Needed for ... In an open-label trial involving adults with mild asthma, budesonide–formoterol used as needed was superior to albuterol used as needed for the prevention of ...

4. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-022-02049-0

Adherence and quality of life assessment in patients with ... Treatment with FDC of budesonide/formoterol via the Elpenhaler device was associated with improvement in asthma-related quality of life and lung function over ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213219825002600

Long-Term Effectiveness of a Digital Inhaler on Medication ... Intervention and control patients received an electronic monitoring device attached to their budesonide/formoterol SYMBICORT Turbuhaler maintenance inhaler.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33548020/

Safety of As-Needed Budesonide-Formoterol in Mild Asthma Conclusions: Budesonide-formoterol anti-inflammatory reliever therapy is generally well-tolerated in patients with mild asthma and has a safety ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7994217/

Safety of As-Needed Budesonide-Formoterol in Mild Asthma Budesonide-formoterol anti-inflammatory reliever therapy is generally well-tolerated in patients with mild asthma. No new safety concerns were ...

8. publications.ersnet.org publications.ersnet.org/content/erj/43/1/103

Safety of formoterol in asthma clinical trials: an update Nonfatal asthma-related serious adverse events were significantly reduced with formoterol (relative risk 0.63, 95% CI 0.53–0.75), as were discontinuations due ...

9. symbicorttouchpoints.com symbicorttouchpoints.com/asthma-clinical-trials.html

Asthma Clinical Trial Data for SYMBICORT® (budesonide ... Sustained improvement in lung function was demonstrated in asthma patients ≥12 years of age in a 12-week efficacy and safety study.