40 Participants NeededMy employer runs this trial

Albuterol + Budesonide for Asthma

MM
SD
Overseen BySonia Dipti Meena Velmurugan, MS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Miami
Must be taking: Inhaled corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two inhalers to assess their impact on lung function in people with asthma. Researchers aim to understand how these treatments might alter airflow in the lungs and enhance breathing. Participants will first use an albuterol inhaler, followed by a combined albuterol-budesonide inhaler. This trial suits adults diagnosed with asthma who have used a consistent dose of inhaled steroids for at least three months. As a Phase 4 trial, the research focuses on understanding how the already FDA-approved treatment can benefit more patients.

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

You need to have been on a steady dose of inhaled corticosteroids (ICS) for at least 3 months before joining the trial. You cannot use systemic glucocorticosteroids or oral methyl-xanthines within 30 days of the study visit.

What is the safety track record for Albuterol-Budesonide and Albuterol Sulfate?

Research shows that the combination of albuterol and budesonide, known as AIRSUPRA, is generally well-tolerated. Studies have found that this combination significantly reduces the risk of severe asthma attacks compared to albuterol alone, lowering the risk by up to 47%. Importantly, no major safety concerns have emerged with this treatment.

Albuterol sulfate alone is a common asthma medication and is considered safe. A review found that it can sometimes cause palpitations or a fast heartbeat, but no serious safety issues have been reported. Overall, both treatments have undergone thorough testing and are considered safe options for managing asthma.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of Albuterol and Budesonide for asthma because it offers a novel approach to managing the condition. Unlike standard treatments that typically involve using a bronchodilator like Albuterol alone, this combination also includes Budesonide, a corticosteroid, which helps in reducing inflammation in the airways. This dual action not only provides immediate relief by opening up the airways but also addresses the underlying inflammation, potentially offering more comprehensive asthma control. The use of a metered-dose inhaler with a spacer ensures effective delivery of both medications, which could improve the overall management of asthma symptoms.

What is the effectiveness track record for Albuterol-Budesonide in treating asthma?

Research has shown that using albuterol with budesonide helps reduce asthma flare-ups. One study showed that this combination lowered the risk of severe asthma attacks by 27% compared to albuterol alone. Another study found a 47% reduction in severe asthma flare-ups with this treatment. It also decreased the yearly number of severe episodes, proving its effectiveness. In this trial, participants will first receive Albuterol Sulfate, followed by the combination of Albuterol/Budesonide, allowing for a direct comparison of their effectiveness in managing asthma symptoms.678910

Who Is on the Research Team?

TS

Trishul Siddharthan, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with asthma, who have been on a steady dose of inhaled steroid medication for at least 3 months and have moderately reduced lung function that improves with treatment. People who smoke, vape, are pregnant or breastfeeding, recently had a respiratory infection, or can't tolerate the study drugs cannot join.

Inclusion Criteria

I am between 18 and 75 years old.
I have used inhaled corticosteroids regularly for at least 3 months.
I have been diagnosed with asthma by my doctor.
See 1 more

Exclusion Criteria

Current nicotine vaping
Pregnant and breast-feeding women
Inhaled corticosteroids (ICS)/fast-acting beta agonist (FABA) intolerance
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants will inhale Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide) via metered-dose inhaler (MDI) with spacer

2 visits
2 visits (in-person)

Follow-up

Participants are monitored for changes in regional ventilation and perfusion using functional lung imaging

30-60 minutes after treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Albuterol-Budesonide
  • Albuterol Sulfate

Trial Overview

The study compares how two inhaler treatments—albuterol alone versus albuterol combined with budesonide—affect airflow and blood flow in the lungs of people with asthma. Participants receive these treatments and undergo imaging to measure changes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Australian Lung Health Initiative Pty Ltd

Collaborator

Citations

Albuterol–Budesonide Fixed-Dose Combination Rescue ...

The annualized rate of severe asthma exacerbations was 0.43 (95% CI, 0.33 to 0.58) in the higher-dose combination group and 0.58 (95% CI, 0.44 to 0.77) in the ...

AIRSUPRA® (albuterol/budesonide) demonstrated ...

Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca's AIRSUPRA ® (albuterol/budesonide) met the primary endpoint ...

Efficacy and safety of as-needed albuterol–budesonide versus ...

As-needed albuterol–budesonide 180/160 µg reduced the risk of severe exacerbations by 27% compared with as-needed albuterol 180 µg in patients aged ≥12 years, ...

Albuterol/Budesonide Reduces Overall Use of ...

Albuterol/budesonide significantly reduces severe asthma exacerbation risk compared to albuterol alone, as shown in the BATURA trial. The ...

As-needed albuterol-budesonide found to benefit mild asthma

Previous studies in patients with more moderate to severe asthma demonstrated a 26% reduction in exacerbations with albuterol-budesonide ...

Safety outcomes of salbutamol: A systematic review and meta ...

This meta‐analysis indicated that salbutamol was associated with a very common risk of palpitations or tachycardia.

N205-636 Albuterol sulfate Clinical PREA

Analysis of the safety data did not demonstrate an important safety signal with the use of Albuterol. MDPI and the results support the safety ...

Albuterol - StatPearls - NCBI Bookshelf

Albuterol is a commonly prescribed bronchodilator used for managing diverse respiratory conditions, including asthma and exercise-induced bronchospasm.

Comparative Efficacy and Safety of Albuterol Sulfate Spiros ...

Both active treatments were superior to the placebo treatment. The Spiros DPI was well tolerated and was as effective as the albuterol MDI in treating patients ...

Safety of Daily Albuterol in Infants with a History ...

The most frequently reported AEs were pyrexia in 7 (24%), 2 (7%), and 3 (11%) subjects in the albuterol 180µg, albuterol 90µg, and placebo groups, respectively.