Fluticasone + Albuterol for Asthma

Recruiting at 448 trial locations

Overseen By Teva U.S. Medical Information

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Must be taking: Inhaled asthma controllers

Disqualifiers: Life-threatening asthma, Recent CAE, Smoking, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks minimum

2196 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of combining fluticasone, a steroid that reduces inflammation, with albuterol, a medication that opens the airways, in preventing severe asthma attacks. Participants will use an inhaler that tracks usage and symptoms. The trial compares high-dose and low-dose combinations of the two medications against albuterol alone. It seeks individuals who have had asthma for at least a year and have experienced severe asthma attacks in the past year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking asthma treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be using a stable dose of their prescribed inhaled asthma controller medication for at least 1 month before the screening visit.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fluticasone propionate, a medication for asthma, is generally safe and well-tolerated. One study found that serious side effects were similar across different treatments, with no unexpected problems. Additionally, asthma flare-ups were rare, indicating a good safety record.

Another study examined the long-term use of fluticasone propionate in two different doses and confirmed its safety. There were no major concerns, which reassures those considering this treatment.

These findings suggest that both high and low doses of fluticasone propionate, when used with albuterol sulfate, are safe and manageable for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments TEV-56248 High Dose and TEV-56248 Low Dose because they offer a new approach to managing asthma symptoms. Unlike standard treatments like standalone albuterol or fluticasone inhalers, these investigational treatments combine both medications into a single inhalation powder, delivered via a multidose dry powder inhaler with an integrated electronic module (eMDPI). This innovative delivery method allows for precise dosing and monitoring, potentially improving adherence and outcomes for patients. By offering both high and low dose options, this treatment approach provides flexibility in managing varying asthma severity, which is a promising advancement in asthma care.

What evidence suggests that this trial's treatments could be effective for asthma?

Research has shown that fluticasone propionate can greatly improve lung function in people with asthma. It reduces asthma symptoms and prevents severe flare-ups. Studies have found that even lower doses of fluticasone, when used with a special inhaler, work better than a placebo. In this trial, participants may receive either a high or low dose of TEV-56248, which contains fluticasone. Albuterol sulfate, a well-known treatment, quickly eases asthma symptoms by relaxing the muscles in the airways. Participants in another arm of this trial will receive albuterol sulfate. Using fluticasone and albuterol together has been shown to prevent asthma flare-ups, providing a strong way to manage asthma. ^{6 7 8 9 10}

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am not pregnant, breastfeeding, trying to get pregnant, and won't for the study's duration.

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

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

Exclusion Criteria

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

You have used a lot of alcohol or illegal drugs in the past 2 years.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Run-in

Participants undergo a run-in period to stabilize their condition before the main treatment phase

2-4 weeks

Treatment

Participants receive either high dose or low dose fluticasone propionate/albuterol sulfate or albuterol sulfate alone to assess efficacy in preventing severe asthma exacerbations

24 weeks minimum

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 35 months

What Are the Treatments Tested in This Trial?

Interventions

• Albuterol Sulfate
• Fluticasone Propionate

Trial Overview 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.

How Is the Trial Designed?

Group I: TEV-56248 Low Dose Experimental Treatment 1 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 Dose Experimental Treatment 1 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 sulfate Active Control 1 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.

Albuterol Sulfate is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Albuterol Sulfate for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Bronchospasm

Approved in European Union as Salbutamol sulfate for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Bronchospasm

Approved in Canada as Salbutamol sulfate for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Bronchospasm

Approved in Japan as Salbutamol sulfate for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Bronchospasm

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D, Inc.

Lead Sponsor

Trials

258

Recruited

3,487,000+

Dr. Eric Hughes

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Biochemistry from the University of Manchester

Published Research Related to This Trial

The combination of fluticasone furoate (FF) and vilanterol (VI) was well tolerated over 52 weeks in patients with asthma, showing a similar safety profile to fluticasone propionate (FP) with no significant clinical concerns.

While FF/VI had a slightly higher incidence of oral candidiasis compared to FP, it did not cause clinically important changes in glucose, potassium levels, or heart rate, indicating its safety for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β2 agonist vilanterol administered once daily for 52 weeks in patients >=12 years old with asthma: a randomised trial. Busse, WW., O'Byrne, PM., Bleecker, ER., et al.[2021]

Inhaled beclomethasone dipropionate significantly improved lung function (measured by FEV1, FVC, and PEFR) and reduced serum eosinophil cationic protein (sECP) levels in asthmatic adults over an 8-week period, indicating its effectiveness in managing asthma inflammation.

Compared to budesonide, beclomethasone dipropionate showed greater improvements in lung function and a more significant decrease in asthma symptoms, with no adverse reactions reported, suggesting it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of inhaled beclomethasone dipropionate and budesonide dry powder on pulmonary function and serum eosinophil cationic protein in adult asthmatics. Dal Negro, R., Micheletto, C., Tognella, S., et al.[2013]

In a study involving 52 subjects with mild asthma, both fluticasone furoate (FF) and the combination of fluticasone furoate with vilanterol (FF/VI) provided significant bronchoprotection against allergen-induced asthma responses, demonstrating their efficacy as once-daily treatments.

The treatments were well tolerated, and both FF and FF/VI showed similar levels of bronchoprotection, indicating that they can be effective options for asthma maintenance therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined fluticasone furoate/vilanterol reduces decline in lung function following inhaled allergen 23 h after dosing in adult asthma: a randomised, controlled trial. Oliver, A., Quinn, D., Goldfrad, C., et al.[2021]

The study found significant differences in the fine particle doses of albuterol sulfate among the three inhalers: Ventolin delivers 21 μg, Proventil delivers 40 μg, and ProAir delivers 64 μg, indicating that Proventil and ProAir provide 2 to 3 times more medication likely to reach the lungs compared to Ventolin.

Using a valved holding chamber (VHC) effectively reduces the delivery of larger particles from all three inhalers without affecting the fine particle dose, suggesting that VHCs can enhance the therapeutic efficacy of these inhalers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a holding chamber on albuterol metered-dose inhaler product differences. Johnson, JL., Guthrie, D., Hyde, J., et al.[2017]

In a study involving 32 adult patients with asthma, both the Easyhaler and Turbuhaler inhalers delivered salbutamol effectively, showing similar significant increases in lung function (FEV1) after treatment, with maximum percentage changes of 43.9% and 40.5%, respectively.

Patients found the Easyhaler easier to use compared to the Turbuhaler, with 65% rating it as very easy and 44% of those who previously used Turbuhaler considering Easyhaler to be better.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salbutamol via Easyhaler is at least as effective as salbutamol via Turbuhaler in the treatment of histamine-induced bronchoconstriction. Zetterström, O., Lähelmä, S., Keski-karhu, J., et al.[2019]

In a study involving 210 patients aged 12 and older with asthma, the combination therapy of fluticasone/formoterol was found to be as effective as using the two medications separately, with no significant difference in lung function measured by FEV1 after 12 weeks of treatment.

The safety and tolerability of the fluticasone/formoterol combination were similar to those of the individual medications, indicating that this combination therapy is a safe and effective option for managing asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety profile of fluticasone/formoterol combination therapy compared to its individual components administered concurrently in asthma: a randomised controlled trial. Bodzenta-Lukaszyk, A., van Noord, J., Schröder-Babo, W., et al.[2015]

In a Phase 3 study involving 279 patients with moderate to severe asthma, fluticasone/formoterol was found to be as effective as budesonide/formoterol in improving lung function, measured by the change in pre-dose FEV₁ over 12 weeks.

Both treatments demonstrated a similar safety profile, indicating that fluticasone/formoterol is a viable alternative to budesonide/formoterol for asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluticasone/formoterol combination therapy versus budesonide/formoterol for the treatment of asthma: a randomized, controlled, non-inferiority trial of efficacy and safety. Bodzenta-Lukaszyk, A., Buhl, R., Balint, B., et al.[2015]

Fluticasone propionate/formoterol fumarate (FP/FORM) combination therapy improved lung function in children with asthma, showing similar efficacy to fluticasone propionate/salmeterol (FP/SAL) over a 12-week period, with no significant differences in safety or tolerability between the two treatments.

The study involved 211 children aged 4-12 years, and both therapies were well-tolerated, with FP/FORM showing no adverse effects on plasma cortisol levels, indicating it is a safe long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 12-week open-label, randomized, controlled trial and 24-week extension to assess the efficacy and safety of fluticasone propionate/formoterol in children with asthma. Emeryk, A., Klink, R., McIver, T., et al.[2018]

In a study involving 60 adolescents and adults with asthma and exercise-induced bronchoconstriction (EIB), the combination of albuterol and budesonide significantly reduced the maximum percentage fall in lung function (FEV1) after exercise compared to placebo, showing a difference of -13.51%.

The treatment was effective for 78.3% of participants, who experienced less than a 10% drop in FEV1 after exercise, compared to only 28.3% in the placebo group, indicating strong efficacy and good tolerability of the albuterol/budesonide combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Albuterol/budesonide for the treatment of exercise-induced bronchoconstriction in patients with asthma: The TYREE study. LaForce, C., Chipps, BE., Albers, FC., et al.[2022]

Zafirlukast, administered at 20 mg twice daily for 6 weeks, significantly improved morning and evening peak expiratory flows (PEFs) and reduced asthma symptoms in 32 asthmatic patients, indicating its efficacy as a treatment option.

Younger patients (under 50 years) and those with better pulmonary function (FEV1 above 80% and FVC above 85% of predicted values) showed a greater response to zafirlukast, suggesting it may be particularly beneficial for this group when other treatments are insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of zafirlukast in the treatment of patients with bronchial asthma. Tsai, JJ., Chan, SC., Ho, CK., et al.[2021]

A study involving 157 children aged 6 to 12 years demonstrated that extended-release albuterol tablets significantly improved lung function and reduced asthma symptoms compared to a placebo, with positive results observed as early as day 1.

The treatment was well tolerated, with no serious adverse events reported, indicating that extended-release albuterol is a safe and effective option for managing asthma in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-release albuterol in the treatment of 6- to 12-year-old asthmatic children. Skoner, DP., Boltansky, H., Kobayashi, RH., et al.[2013]

Co-inhalation of roflumilast and fluticasone significantly reduced airway hyperresponsiveness and improved inflammation in ovalbumin-sensitized asthmatic mice, suggesting its potential effectiveness in treating asthma.

Roflumilast, when combined with fluticasone, showed greater improvements in inflammatory markers and histopathological changes compared to the combination of formoterol and fluticasone, indicating its potential off-label use in eosinophilic and neutrophilic asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-inhalation of roflumilast, rather than formoterol, with fluticasone more effectively improves asthma in asthmatic mice. Murad, HA., Habib, HS., Rafeeq, MM., et al.[2023]

Leukotriene receptor antagonists (LTRAs) like montelukast and zafirlukast are effective in treating asthma, showing bronchodilating and anti-inflammatory properties that complement inhaled corticosteroids, especially in patients with moderate asthma.

Clinical studies indicate that LTRAs can improve asthma control and allow for reduced corticosteroid dosages, with montelukast providing similar benefits to inhaled corticosteroids in patients with mild persistent asthma over a 6-week treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leukotriene receptor antagonists in the treatment of asthma: an update. Balzano, G., Fuschillo, S., Gaudiosi, C.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06052267?utm_source=trialradar

A Study to Test if a Fixed-Dose Combination of Fluticasone ... A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/​Albuterol Sulfate is Effective in Preventing Asthma Exacerbations. ClinicalTrials.gov ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8627205/

Fluticasone propionate aerosol: efficacy in patients with ... These data indicate that fluticasone propionate aerosol is an effective and well-tolerated treatment for asthma and significantly improves pulmonary function.

3. tevausa.com tevausa.com/news-and-media/press-releases/teva-reports-positive-top-line-results-from-phase-iii-trials-evaluating-fluticasone-propionatesalmeterol/

Teva Reports Positive Top-Line Results from Phase III ... Studies demonstrate greater efficacy with lower doses delivered via multidose dry-powder inhaler (MDPI) compared to placebo. Results ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02980133

Study of Fluticasone Propionate Multidose Dry Powder ... This study is to evaluate the safety and efficacy of fluticasone propionate and fluticasone propionate salmeterol in pediatric participants with a documented ...

5. ichgcp.net ichgcp.net/clinical-trials-registry/NCT06052267

TEV-56248 and Albuterol sulfate in Asthma - ICH GCP A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06290102

Study Details | NCT06290102 | Pharmacokinetic Profile ... To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI); To ...

7. tevapharm.com tevapharm.com/teva-clinical-trials/clinical-trials-results/clinical-trials/fpaas30094

Fixed-Dose Fluticasone Propionate/Albuterol Sulfate in ... The primary objective of the study is to assess the efficacy of high dose and low dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28540844/

A 6-month safety and efficacy study of fluticasone ... Serious AEs were similar between the treatments, with no unexpected findings. The incidence of asthma exacerbations was low and generally ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02175771

Long-Term Safety Study of Fluticasone Propionate (Fp ... The primary objective of the study is to evaluate the long-term safety of fluticasone propionate (Fp) inhalation powder in 2 strengths and fluticasone ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0954611125002343

Comparative effectiveness of inhaled fluticasone ... The overall results showed that both regimens were effective, with no significant differences between the two cohorts in terms of asthma control, exacerbation ...