Fluticasone Propionate/Albuterol Sulfate for Asthma

Recruiting at 135 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: Beta-agonists

Disqualifiers: Life-threatening asthma, Respiratory infection, Smoking, others

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: 3

Duration: 4 weeks

724 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new inhaler that combines fluticasone propionate (a corticosteroid) and albuterol sulfate (a bronchodilator) to assess its effectiveness for asthma patients. The researchers aim to determine if using this inhaler four times a day is both effective and safe. Individuals who have had asthma for at least six months and currently use a rescue inhaler might be suitable candidates for this trial. Participants will use the inhaler and undergo monitoring over approximately ten weeks to gather data on its effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially new 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 can currently be on a beta-agonist or asthma controller medication, so you might be able to continue those.

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

Research has shown that fluticasone propionate and albuterol sulfate, both used to treat asthma, are generally safe. Studies on inhaled fluticasone propionate indicate it is well-tolerated, especially at normal doses, with mild side effects such as throat irritation or a hoarse voice.

The FDA has approved albuterol sulfate for asthma treatment, and it is widely used. While effective, it may cause side effects like a fast heartbeat or nervousness, but these are usually not serious.

Studies have examined the combined use of fluticasone propionate and albuterol sulfate for efficacy and safety. No major safety issues have been found, and the combination is considered tolerable with typical asthma medication side effects. These findings suggest a reassuring level of safety for those considering joining a trial, based on previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for asthma because they combine two well-known medications, fluticasone propionate and albuterol sulfate, into a single multidose dry powder inhaler with an integrated electronic module (eMDPI). This eMDPI technology offers a unique advantage by potentially improving medication adherence and tracking usage, which is crucial for managing asthma effectively. Unlike traditional inhalers, which require manual tracking, the electronic module records each use, providing valuable data to both patients and healthcare providers. This innovation could lead to better asthma control and more personalized treatment plans.

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

This trial will compare different treatments for asthma, including the combination of fluticasone propionate and albuterol sulfate, which participants may receive. Research has shown that using fluticasone propionate with albuterol sulfate effectively treats asthma. Specifically, a study with 96 patients who had severe asthma found that taking fluticasone propionate at 1000 micrograms twice a day for 16 weeks greatly improved their quality of life. This medication also improves lung function, as seen in tests measuring exhaled air volume and peak breathing flow. Albuterol sulfate reduces emergency room visits and hospital stays due to asthma. Using these treatments together may provide quick relief from asthma symptoms and help manage the condition over time. ^{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 individuals aged 12 and older who have been diagnosed with asthma for at least six months. Participants should be using a beta-agonist or ICS as rescue medication, possibly alongside other asthma controllers. Women must not be pregnant, breastfeeding, or planning pregnancy during the trial.

Inclusion Criteria

I understand there may be more criteria to meet.

I use a rescue inhaler like albuterol for my asthma.

I have been diagnosed with asthma for at least 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive Fp/ABS eMDPI or comparator treatments four times daily

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Albuterol Sulfate
• Fluticasone Propionate

Trial Overview The study tests a combination inhaler (Fp/ABS eMDPI) against separate components (FP and ABS) and placebo to see if it's more effective for asthma when used four times daily. It also looks into how the body processes these medications after one dose.

How Is the Trial Designed?

Group I: Fp/ABS eMDPI Experimental Treatment 1 Intervention

Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module

Group II: Fp eMDPI Active Control 1 Intervention

Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)

Group III: ABS eMDPI Active Control 1 Intervention

Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)

Group IV: Placebo eMDPI Placebo Group 1 Intervention

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

A study involving 39 adult patients with chronic stable bronchial asthma found that fluticasone propionate delivered through various devices (dry powder inhaler, metered dose inhaler, metered dose inhaler with spacer, and nebulizer) showed no significant differences in lung function outcomes, indicating similar efficacy across devices.

The results suggest that these delivery methods can be used interchangeably for administering fluticasone propionate, as they all effectively maintain lung function without any significant variation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of delivery devices on efficacy of inhaled fluticasone propionate: a comparative study in stable asthma patients. Kolasani, BP., Lanke, VM., Diyya, S.[2021]

In a study of 96 patients with severe asthma, treatment with fluticasone propionate at 1000 micrograms twice daily for 16 weeks significantly improved quality of life scores in areas such as physical functioning and general health compared to placebo.

These quality of life improvements were sustained over a subsequent year of open-label treatment, indicating that fluticasone propionate not only enhances pulmonary function but also has a lasting positive impact on patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluticasone propionate improves quality of life in patients with asthma requiring oral corticosteroids. Okamoto, LJ., Noonan, M., DeBoisblanc, BP., et al.[2015]

Fluticasone propionate is an inhaled corticosteroid that has high anti-inflammatory activity, making it potentially effective for treating asthma.

Due to its low gastrointestinal absorption and rapid liver metabolism, fluticasone propionate is expected to cause minimal systemic side effects, enhancing its safety profile for asthma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology of fluticasone propionate. Sastre, J.[2015]

High doses of fluticasone propionate, an inhaled corticosteroid, can lead to growth retardation and adrenal suppression in children with severe asthma, as observed in a case study of six affected children.

Reducing the fluticasone dose to 500 micrograms/day resulted in the normalization of growth rate and cortisol response in one child, highlighting the importance of monitoring and adjusting dosages to prevent adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth and adrenal suppression in asthmatic children treated with high-dose fluticasone propionate. Todd, G., Dunlop, K., McNaboe, J., et al.[2019]

Fluticasone propionate, administered at 500 micrograms twice daily via Diskus and Diskhaler devices, significantly improved lung function and reduced asthma symptoms in 213 participants over 12 weeks, demonstrating its efficacy in treating mild-to-moderate asthma.

The treatment was well tolerated, with similar rates of adverse events across all groups, and fewer patients in the fluticasone groups withdrew due to lack of efficacy compared to the placebo group, indicating its effectiveness and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diskus and diskhaler: efficacy and safety of fluticasone propionate via two dry powder inhalers in subjects with mild-to-moderate persistent asthma. Galant, SP., van Bavel, J., Finn, A., et al.[2018]

Ciclesonide, an inhaled corticosteroid, was found to have minimal impact on adrenal function, as indicated by stable cortisol levels in patients with mild-to-moderate asthma, compared to significant reductions seen with fluticasone propionate.

The study, which involved 164 adults over 12 weeks, also reported lower rates of oral candidiasis with ciclesonide (2.5% and 2.4%) compared to fluticasone propionate (22.0%), highlighting ciclesonide's safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ciclesonide and fluticasone on hypothalamic-pituitary-adrenal axis function in adults with mild-to-moderate persistent asthma. Lipworth, BJ., Kaliner, MA., LaForce, CF., et al.[2022]

In a 12-month study involving 257 children aged 4-17 with moderately severe asthma, fluticasone propionate was found to have a low incidence of serious adverse events, with only 3% of participants withdrawing due to potential drug-related issues.

The most common adverse events reported were typical for asthma patients, such as asthma exacerbations and upper respiratory infections, indicating that fluticasone propionate is generally safe for long-term use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open study to assess the long-term safety of fluticasone propionate in asthmatic children. International Study Group. MacKenzie, CA., Tsanakas, J., Tabachnik, E., et al.[2015]

Fluticasone propionate has been shown to be effective in managing asthma, with trial data involving over 4000 adults and more than 1600 children, indicating its broad applicability across different age groups.

At half the daily dose, fluticasone propionate is at least as effective as budesonide and equally effective as beclomethasone dipropionate, suggesting it may offer a more efficient dosing option for asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma: the role of fluticasone propionate. [2015]

Inhaled fluticasone propionate at doses of up to 500 microg/day is an effective treatment for mild to moderate asthma, showing significant improvements in lung function and reduced asthma symptoms compared to placebo and other medications.

Fluticasone propionate is well tolerated with a low incidence of adverse effects, and it does not significantly affect the hypothalamo-pituitary-adrenal (HPA) axis, making it a safe option for asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled fluticasone propionate: a review of its therapeutic efficacy at dosages Jarvis, B., Faulds, D.[2018]

Fluticasone propionate aerosol significantly improved asthma control compared to placebo, with only 4% of patients on the highest dose (500 micrograms) needing to be removed from the study due to worsening symptoms, compared to 63% of placebo patients.

The treatment was found to be safe, with similar rates of adverse events across all groups, and it did not significantly affect cortisol levels, indicating a favorable safety profile for managing mild to moderate asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluticasone propionate aerosol for the treatment of adults with mild to moderate asthma. The Fluticasone Propionate Asthma Study Group. Chervinsky, P., van As, A., Bronsky, EA., et al.[2019]

In a study involving 44 patients with moderate to severe asthma, both fluticasone aerosol combined with theophylline tablets and salmeterol/fluticasone propionate aerosol significantly improved lung function and reduced inflammation markers after 12 weeks of treatment, with no significant differences between the two groups.

Both treatment regimens were found to be safe, as there were no significant abnormalities in blood biochemistry, ECG results, or vital signs, suggesting that fluticasone combined with theophylline could be a viable option for asthma management, especially in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention Studies of Inhaled Corticosteroids Combined with Long-acting Theophylline or Long-acting β2-agonists in Patients with Moderate to Severe Asthma: A Randomized, Controlled Study. Wang, Y., Chen, P., Dai, A., et al.[2019]

Inhaled fluticasone propionate significantly improved asthma control compared to oral fluticasone propionate and placebo, with higher FEV1 and PEF rates, indicating its effectiveness as a treatment.

The study suggests that the benefits of inhaled fluticasone propionate are primarily due to its topical effects in the lungs rather than systemic effects, as shown by lower systemic exposure in patients using the inhaled form.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of inhaled fluticasone propionate in asthma results from topical and not from systemic activity. Lawrence, M., Wolfe, J., Webb, DR., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5008637/

Historical cohort study examining comparative ... This study compared respiratory-related emergency department (ED) visit rates in patients with asthma, chronic obstructive pulmonary disease, or ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ppul.71293

Estimating the Effects of Continuous Albuterol Dosage on ... Findings suggest that starting continuous albuterol at 10 mg/h provides clinical outcomes comparable to 15 mg/h in managing pediatric critical ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5440041/

Real-world health care utilization in asthma patients using ... In a real-world setting, asthma patients using ProAir HFA with IDC experienced significantly fewer hospitalizations and ED visits compared with patients using ...

4. fda.gov fda.gov/files/205636-Albuterol-sulfate-Statistical-PREA.pdf

205636 Albuterol sulfate Statistical PREA For each of the five treatment period, spirometry data was collected at 30 minutes prior and again within 5 minutes prior to the commencement of ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2504544

As-Needed Albuterol–Budesonide in Mild Asthma The risk of a severe exacerbation was 47% lower with albuterol–budesonide than with albuterol, which led to the trial being stopped after a ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/021457s036lbl.pdf

PROAIR HFA (albuterol sulfate) Label - accessdata.fda.gov inhaler in 172 asthmatic patients 12 to 76 years of age. The table lists ... There are no available data on the presence of albuterol in human milk, the.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482272/

Albuterol - StatPearls - NCBI Bookshelf Albuterol, also known as salbutamol, is approved by the U.S. Food and Drug Association (FDA) for treating and preventing acute or severe ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/albuterol-inhalation-route/description/drg-20073536

Albuterol (inhalation route) - Side effects & dosage Albuterol is used to treat or prevent bronchospasm in patients with asthma, bronchitis, emphysema, and other lung diseases.

9. accessdata.fda.gov accessdata.fda.gov/spl/data/a32718c7-20bd-4601-b82b-43b586952fd5/a32718c7-20bd-4601-b82b-43b586952fd5.xml

a32718c7-20bd-4601-b82b-43b586952fd5.xml ... asthma who receive asthma medications, including Albuterol Sulfate HFA, while pregnant. The purpose of the registry is to collect information about the ...

10. drugs.com drugs.com/albuterol.html

Albuterol Inhaler: Uses, Dosage & Side Effects Albuterol may increase the risk of death or hospitalization in people with asthma, but the risk in people with obstructive airway disease or ...