ICS/LABA for Asthma Nonadherence
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.12345Why 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.36789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive symptom-driven ICS/LABA treatment strategy or standard therapy for asthma
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Active Control
Placebo Group
Symptom-driven ICS/LABA treatment strategy
Continue maintenance ICS and SABA therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Citations
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 ...
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.
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 ...
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 ...
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.
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 ...
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 ...
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 ...
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.
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