What side effects are associated with this type of intervention?

Common side effects of inhaled corticosteroids (ICS) like Budesonide include oral thrush, hoarseness, and throat irritation. Long-acting beta-agonists (LABA) such as Formoterol can cause side effects like tremors, palpitations, and muscle cramps. When used in combination, these medications can effectively manage asthma symptoms but may also increase the risk of pneumonia and other respiratory infections. It is important for patients to use these medications as prescribed and to rinse their mouth after inhalation to minimize side effects.

What prior FDA approvals exist?

The FDA has approved several combination inhalers for the treatment of asthma that include both a corticosteroid and a long-acting beta2-agonist (LABA). Notable examples include fluticasone propionate/salmeterol (Advair), budesonide/formoterol (Symbicort), and mometasone furoate/formoterol (Dulera). These medications work by reducing inflammation in the airways and relaxing the muscles around the airways, making it easier to breathe. These combinations are similar to the budesonide and formoterol fumarate metered dose inhaler being studied in the VATHOS trial.

What other types of research exist?

Promising novel alternatives to Budesonide and Formoterol Fumarate for asthma treatment include: 1) Fluticasone Furoate-Umeclidinium-Vilanterol (FF/UM/VI), a triple therapy inhaler that has shown improved lung function and reduced exacerbations in clinical trials. 2) Beclomethasone-Glycopyrronium-Formoterol, another triple combination inhaler under investigation, which may offer enhanced control of asthma symptoms. These alternatives provide a combination of anti-inflammatory and bronchodilatory effects, similar to Budesonide and Formoterol Fumarate, but with potential additional benefits.

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Corticosteroid

Budesonide + Formoterol Inhaler for Asthma (VATHOS Trial)

Q: What is the mechanism of action of this treatment?

Inhaled corticosteroids (ICS) like Budesonide reduce inflammation in the airways, helping to prevent asthma attacks and control chronic symptoms. Long-acting beta-agonists (LABA) such as Formoterol Fumarate relax the smooth muscles around the airways, leading to bronchodilation and easier breathing. Combining these treatments provides both immediate relief and long-term control of asthma symptoms, which is crucial for improving quality of life and reducing the frequency of exacerbations in asthma patients.

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of ≥ 12% and ≥ 200 mL for participants ≥ 18 years of age OR a post-albuterol increase in FEV1 of ≥ 12% for participants 12 to < 18 years of age, either in the 12 months prior to Visit 1 or at Visit 2 or Visit 3

Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with the ICS doses, for at least 8 weeks prior to Visit 1

Must not have

Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1

For women only - currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 24

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests an inhaler that combines two medications to help people with poorly controlled asthma. It aims to see if this new inhaler can better manage their symptoms by reducing inflammation and keeping airways open. Combination products often have useful clinical benefits in asthma. The scientific rationale for combination therapy includes the fact that different agents have complementary modes of action.

Who is the study for?

Adults and adolescents aged 12-80 with poorly controlled asthma, stable on inhaled corticosteroids or combination therapy for at least 8 weeks. Must have a history of asthma for over 6 months, non-smokers or those who quit smoking more than 6 months ago, not pregnant or breastfeeding, without life-threatening asthma events or recent hospitalizations.

What is being tested?

The trial is testing different doses of Budesonide and Formoterol Fumarate Metered Dose Inhaler (BFF MDI) against an open-label Symbicort inhaler to see which is better at controlling asthma symptoms over a period of 24 weeks.

What are the potential side effects?

Possible side effects include throat irritation, hoarseness, headache, rapid heartbeat, tremors, nervousness. Long-term use can sometimes lead to infections like thrush in the mouth and airways.

Eligibility Criteria

Inclusion Criteria

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

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My lung function improves significantly after using albuterol.

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I have been on a stable asthma medication regimen for at least 8 weeks.

Exclusion Criteria

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

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My cancer cannot be removed by surgery and has not been fully gone for 5 years.

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I am pregnant, breastfeeding, planning to become pregnant, or not using birth control.

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I have had severe asthma attacks that required breathing support.

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I will be hospitalized during the study.

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I currently smoke or have a history of heavy smoking.

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I received my COVID-19 vaccine less than a week ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24

Secondary study objectives

Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks

Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1

Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 24

+3 more

Side effects data

From 2019 Phase 3 trial • 8588 Patients • NCT02465567

11%

Nasopharyngitis

Chronic obstructive pulmonary disease

Upper respiratory tract infection

Pneumonia

Acute respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

BGF MDI 320/14.4/9.6 μg

BGF MDI 160/14.4/9.6 μg

GFF MDI 14.4/9.6 μg

BFF MDI 320/9.6 μg

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

4Treatment groups

Experimental Treatment

Active Control

Group I: BFF MDI 320/9.6 μgExperimental Treatment1 Intervention

Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg

Group II: BFF MDI 160/9.6 μgExperimental Treatment1 Intervention

Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg

Group III: BD MDI 320 μgExperimental Treatment1 Intervention

Budesonide MDI (BD MDI), 320 μg

Group IV: Open-label Symbicort TBH 320/9 μgActive Control1 Intervention

Open-Label Comparator Symbicort Turbuhaler 320/9 μg

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BFF MDI 320/9.6 μg

2014

Completed Phase 3

~11790

BFF MDI 160/9.6 μg

2014

Completed Phase 3

~2570

BD MDI 320 μg

2014

Completed Phase 3

~2570

0 / 8Eligibility 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

Inhaled corticosteroids (ICS) like Budesonide reduce inflammation in the airways, helping to prevent asthma attacks and control chronic symptoms. Long-acting beta-agonists (LABA) such as Formoterol Fumarate relax the smooth muscles around the airways, leading to bronchodilation and easier breathing. Combining these treatments provides both immediate relief and long-term control of asthma symptoms, which is crucial for improving quality of life and reducing the frequency of exacerbations in asthma patients.