What side effects are associated with this type of intervention?

Common treatments for asthma, such as inhaled corticosteroids (ICS) like Fluticasone Propionate and short-acting beta-agonists (SABAs) like Albuterol Sulfate, have known side effects. ICS can cause oral thrush, hoarseness, and, with long-term use, systemic effects like adrenal suppression, osteoporosis, and cataracts. SABAs can lead to tremors, nervousness, headache, tachycardia, and palpitations. Combining these treatments can improve asthma control but necessitates monitoring for these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for asthma that combine corticosteroids and bronchodilators, similar to the fluticasone propionate/albuterol sulfate combination being studied. Notable examples include the combination of fluticasone furoate and vilanterol, which has been shown to improve lung function and reduce exacerbations in patients with asthma. Additionally, other combinations like mometasone furoate/formoterol fumarate have been approved for their efficacy in managing asthma symptoms. These treatments work by reducing airway inflammation and relaxing airway muscles, thereby improving breathing and reducing the frequency of asthma attacks.

What other types of research exist?

Promising novel alternatives to Fluticasone Propionate/Albuterol Sulfate for asthma treatment in 2024 include: 1) Biologics such as Dupilumab, which targets the IL-4 receptor and has shown efficacy in reducing asthma exacerbations and improving lung function. 2) Tezepelumab, an anti-TSLP monoclonal antibody, which has demonstrated significant reductions in asthma exacerbations in clinical trials. 3) Combination therapies like Budesonide/Formoterol and Mometasone/Formoterol, which combine an inhaled corticosteroid with a long-acting beta-agonist for improved symptom control and reduced exacerbations.

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Bronchodilator

Fluticasone + Albuterol for Asthma

Phase 3

Recruiting

Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The participant has a diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines.

The participant has a diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines

Must not have

The participant is a current tobacco smoker or has a smoking history of ≥10 pack-years, or the participant used tobacco within the past 6 months

The participant has been hospitalized for psychiatric disorder or attempted suicide within 1 year of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 35 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests different doses of a combination of fluticasone and albuterol in an electronic inhaler for asthma patients. The goal is to reduce severe asthma attacks by decreasing lung inflammation and opening airways. Fluticasone is a potent anti-inflammatory medication, and albuterol helps to open airways.

Who is the study for?

This trial is for asthma patients with a history of severe exacerbations in the past year, using stable asthma medication for at least a month. It's not for pregnant women or those trying to conceive, recent participants in other drug studies, heavy drinkers/drug users, current/recent smokers, people with life-threatening asthma history or psychiatric hospitalizations.

What is being tested?

The study tests high and low doses of Fluticasone Propionate/Albuterol Sulfate (Fp/ABS) via an inhaler against Albuterol Sulfate alone to prevent severe asthma attacks. Participants will be observed for at least 28 weeks to assess efficacy and safety.

What are the potential side effects?

Potential side effects may include irritation in the throat or mouth, headaches, shaking hands (tremors), fast heart rate (palpitations), muscle cramps, coughing and nervousness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have had a severe asthma attack in the last year.

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I have had a severe asthma attack in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently smoke or have a history of smoking equivalent to 10 pack-years.

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I have not been hospitalized for mental health issues or attempted suicide in the last year.

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I have had severe asthma attacks needing a breathing tube in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 35 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 35 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Annualized Severe CAE Rate

Asthma Control Questionnaire-5 (ACQ-5) Response

Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: TEV-56248 Low DoseExperimental Treatment1 Intervention

Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.

Group II: TEV-56248 High DoseExperimental Treatment1 Intervention

Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.

Group III: Albuterol sulfateActive Control1 Intervention

Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TEV-56248

2024

Completed Phase 1

~30

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for asthma include corticosteroids and bronchodilators. Fluticasone Propionate (Fp) is a corticosteroid that reduces inflammation in the airways, helping to prevent asthma exacerbations and maintain long-term control. Albuterol Sulfate (ABS) is a short-acting beta agonist (SABA) that acts as a bronchodilator, relaxing the muscles around the airways to provide quick relief from acute symptoms. Combining these medications can offer both immediate symptom relief and long-term control, which is essential for effectively managing asthma.

Inhaled fluticasone propionate. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in asthma.