Albuterol + Budesonide for Asthma

(ANCHOR Trial)

Recruiting at 4 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: AstraZeneca

Must be taking: Albuterol, Budesonide

Must not be taking: Oral corticosteroids

Disqualifiers: COPD, Lung cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

2000 Participants Needed

Trial Summary

What is the purpose of this trial?

ANCHOR is a prospective, multi-center, phase IV, interventional, single-arm, open-label study of 2,000 adult participants with symptomatic asthma requiring the use of rescue therapy aimed to compare the asthma exacerbation rates before and after switching from albuterol or levalbuterol to albuterol plus budesonide inhalation aerosol as rescue therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be willing to switch to using albuterol and budesonide as your rescue inhaler. If you are using oral corticosteroids regularly, you may not be eligible to participate.

What data supports the effectiveness of the drug Albuterol + Budesonide Inhalation Aerosol for asthma?

Research shows that using albuterol and budesonide together in a single inhaler can reduce severe asthma attacks more effectively than using albuterol alone. ^{1 2 3 4 5}

Is the combination of Albuterol and Budesonide safe for humans?

The combination of albuterol and budesonide, known as Airsupra, is generally considered safe for treating asthma. Studies have shown that while there may be minor side effects like oral candidiasis (a fungal infection in the mouth), tremor, and throat pain, the benefits of using this combination for asthma relief outweigh these risks. ^{1 5 6 7 8}

What makes the drug Airsupra unique for treating asthma?

Airsupra is unique because it combines albuterol, a fast-acting medication that opens airways, with budesonide, a steroid that reduces inflammation, in a single inhaler to treat acute asthma attacks. This combination can reduce severe asthma exacerbations more effectively than albuterol alone. ^{1 2 7 9 10}

Research Team

Njira Lugogo, MD

Principal Investigator

University of Michigan, Michigan, USA

Neil Skolnik, MD

Principal Investigator

Jefferson Health, Pennsylvania, USA

Eligibility Criteria

This trial is for adults with asthma who often need rescue therapy. Participants should be currently using albuterol or levalbuterol and willing to switch to a combination of albuterol and budesonide as their rescue medication.

Inclusion Criteria

I have had at least one asthma attack in the last year.

I have been diagnosed with asthma in the last year.

I have had both medical and pharmacy insurance for the past year and plan to keep it for the next year.

Exclusion Criteria

I am currently pregnant or breastfeeding.

I haven't had any cancer except skin cancer in the last year.

I have not taken oral steroids regularly in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-switch Observation

Participants' asthma exacerbation rates and medication use are monitored before switching therapy

12 months

Post-switch Observation

Participants switch to albuterol plus budesonide inhalation aerosol and are monitored for asthma exacerbation rates and medication use

12 months

Follow-up

Participants are monitored for safety and effectiveness after the post-switch observation period

3 months

Treatment Details

Interventions

• Albuterol and Budesonide Inhalation Aerosol

Trial Overview The study tests if using a combo inhaler with both albuterol (a bronchodilator) and budesonide (an anti-inflammatory steroid) can reduce the number of severe asthma attacks compared to previous treatments with just albuterol or levalbuterol.

Participant Groups

Group I: Albuterol and budesonide inhalation aerosol Experimental Treatment 1 Intervention

Participants will receive a fixed-dose combination of albuterol (90mcg) and budesonide (80mcg) administered as 2 inhalations (180mcg/160mcg) via pressurized metered dose inhaler (pMDI) as needed for asthma symptoms, for up to 12 inhalations (6 doses) in a 24-hour period.

Albuterol and Budesonide Inhalation Aerosol is already approved in United States for the following indications:

Approved in United States as Airsupra for:

• Treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in patients with asthma 18 years of age and older

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Premier HealthCare Solutions Inc.

Collaborator

Trials

1

Recruited

2,000+

Findings from Research

Airsupra, a new asthma medication, effectively combines albuterol (a short-acting bronchodilator) with budesonide (a corticosteroid) to manage acute asthma attacks.

Patients are advised to continue their regular asthma maintenance therapy even when using Airsupra, ensuring comprehensive asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Combination Asthma Drug. Aschenbrenner, DS.[2023]

The study evaluated the efficacy of a fixed-dose combination rescue inhaler containing albuterol and budesonide for asthma management, demonstrating improved control of asthma symptoms compared to standard treatments.

In a large clinical trial, the combination inhaler was found to provide effective relief during asthma attacks while also reducing the need for additional rescue medication, indicating its potential as a safer and more effective option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In moderate-to-severe asthma, as-needed albuterol-budesonide reduced severe exacerbations vs. albuterol alone. Confalonieri, M.[2022]

In a 52-week study involving 202 children aged 2 to 4 years with mild persistent asthma, both budesonide inhalation suspension (BIS) and montelukast were found to provide acceptable asthma control, with no significant difference in the time to first additional asthma medication.

However, BIS showed statistically significant advantages over montelukast in several secondary outcomes, including a lower percentage of patients requiring oral steroids (21.9% vs 37.1%) and fewer additional courses of medication, indicating it may be a more effective option for managing asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budesonide inhalation suspension versus montelukast in children aged 2 to 4 years with mild persistent asthma. Szefler, SJ., Carlsson, LG., Uryniak, T., et al.[2021]

In a 12-week study involving 128 older asthmatics, the combination of montelukast with low-dose inhaled budesonide (MON-400BUD) was found to be as effective as increasing the dose of inhaled budesonide (800BUD) in achieving well-controlled asthma status.

However, the MON-400BUD group experienced significantly fewer asthma exacerbations requiring oral corticosteroids and fewer cases of sore throat compared to the 800BUD group, suggesting a safer profile for the lower-dose combination treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of Montelukast to Low-Dose Inhaled Corticosteroid Leads to Fewer Exacerbations in Older Patients Than Medium-Dose Inhaled Corticosteroid Monotherapy. Ye, YM., Kim, SH., Hur, GY., et al.[2020]

In a study involving 2200 adult asthma patients, the use of Bufomix Easyhaler® significantly improved asthma control, with the percentage of patients achieving well-controlled asthma rising from 46.6% to 90.8% over three visits.

Patient adherence to the medication also increased from 88% to 95.3%, and overall satisfaction with the inhaler improved, with only one reported adverse drug reaction, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficiency of Single-Inhaler Combination Therapy with Budesonide/Formoterol Fumarate in Patients with Bronchial Asthma in Daily Clinical Practice. Pirożyński, M., Hantulik, P., Almgren-Rachtan, A., et al.[2019]

In a study involving 3132 patients with uncontrolled moderate-to-severe asthma, the fixed-dose combination of albuterol and budesonide significantly reduced the risk of severe asthma exacerbations by 26% compared to albuterol alone.

The safety profile was similar across all treatment groups, indicating that the combination therapy is not only more effective but also safe for patients already on inhaled glucocorticoid maintenance therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. Papi, A., Chipps, BE., Beasley, R., et al.[2023]

The combination inhaler of budesonide and formoterol provides both maintenance and quick relief for asthma, effectively reducing exacerbations and preventing overuse of short-acting beta-agonists.

Safety concerns regarding long-acting beta-agonists have not been supported by studies on the budesonide/formoterol inhaler, suggesting that its benefits outweigh any potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budesonide/formoterol in the treatment of asthma. Hodgson, D., Mortimer, K., Harrison, T.[2015]

In a 52-week study involving 708 patients with moderate to severe asthma, the combination of budesonide/formoterol showed a significantly lower rate of asthma exacerbations compared to budesonide alone, indicating improved efficacy in asthma management.

The safety profile of budesonide/formoterol was acceptable, with no significant differences in adverse events or clinical abnormalities compared to budesonide, suggesting that adding a long-acting beta(2)-adrenergic agonist (LABA) to inhaled corticosteroids (ICSs) is safe for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and asthma control with budesonide/formoterol versus budesonide pressurized metered-dose inhaler in asthma patients. Peters, SP., Prenner, BM., Mezzanotte, WS., et al.[2022]

A new high-performance thin-layer chromatography (HPTLC) method was developed to simultaneously estimate budesonide and levosalbutamol, which are used together to treat asthma and chronic obstructive pulmonary disease, optimizing conditions through a systematic design of experiments approach.

The study found that both drugs degrade under acidic and basic conditions, but the method effectively separates the degraded products from the pure drugs, ensuring accurate analysis and quantification, which is crucial for maintaining drug safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability-Indicating Analytical Method Development Using Quality by Design (QbD) Approach for Simultaneous Estimation of Budesonide and Levosalbutamol. Gandhi, N., Ezhava, S.[2022]

In a study involving 321 adults with asthma, the budesonide/formoterol single inhaler showed significantly better treatment adherence, with only 9% of patients withdrawing compared to 19% for the separate inhalers (P=0.008).

Both treatment methods demonstrated similar long-term safety and efficacy, with no significant differences in adverse events, lung function improvements, or quality of life scores over 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year safety and efficacy of budesonide/formoterol in a single inhaler (Symbicort Turbuhaler) for the treatment of asthma. Rosenhall, L., Elvstrand, A., Tilling, B., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

New Combination Asthma Drug. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

In moderate-to-severe asthma, as-needed albuterol-budesonide reduced severe exacerbations vs. albuterol alone. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Budesonide inhalation suspension versus montelukast in children aged 2 to 4 years with mild persistent asthma. [2021]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Addition of Montelukast to Low-Dose Inhaled Corticosteroid Leads to Fewer Exacerbations in Older Patients Than Medium-Dose Inhaled Corticosteroid Monotherapy. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficiency of Single-Inhaler Combination Therapy with Budesonide/Formoterol Fumarate in Patients with Bronchial Asthma in Daily Clinical Practice. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Budesonide/formoterol in the treatment of asthma. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Long-term safety and asthma control with budesonide/formoterol versus budesonide pressurized metered-dose inhaler in asthma patients. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Stability-Indicating Analytical Method Development Using Quality by Design (QbD) Approach for Simultaneous Estimation of Budesonide and Levosalbutamol. [2022]

10. England pubmed.ncbi.nlm.nih.gov

One-year safety and efficacy of budesonide/formoterol in a single inhaler (Symbicort Turbuhaler) for the treatment of asthma. [2019]