Fluticasone Propionate/Albuterol Sulfate for Asthma

Recruiting at 33 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

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)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI). Secondary objectives are: * To evaluate the efficacy of Fp/ABS eMDPI administered four times daily * To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeks * To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose The planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.

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.

What data supports the effectiveness of the drug Fluticasone Propionate/Albuterol Sulfate for asthma?

Research shows that Fluticasone Propionate, a part of this drug combination, is effective in improving lung function and reducing asthma symptoms. It works as a strong anti-inflammatory agent, helping to control asthma when inhaled. ^{1 2 3 4 5}

Is Fluticasone Propionate safe for humans?

Fluticasone Propionate has been studied for safety in both children and adults with asthma. In a study with children, some reported adverse events like asthma symptoms and infections, but only a few were possibly related to the drug. Another study noted concerns about adrenal suppression (a condition where the adrenal glands don't produce enough hormones) at higher doses. ^{6 7 8 9 10}

What makes the drug Fluticasone Propionate/Albuterol Sulfate unique for asthma treatment?

Fluticasone Propionate/Albuterol Sulfate combines a potent anti-inflammatory corticosteroid (Fluticasone Propionate) with a fast-acting bronchodilator (Albuterol Sulfate), offering both long-term control and quick relief for asthma symptoms. This combination is unique because it addresses both inflammation and immediate airway constriction, potentially reducing the need for separate medications. ^{1 2 3 11 12}

Research Team

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Albuterol Sulfate (Bronchodilator)
• Fluticasone Propionate (Corticosteroid)

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

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

Fluticasone propionate improves quality of life in patients with asthma requiring oral corticosteroids. [2015]

2. United States 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. [2018]

3. India pubmed.ncbi.nlm.nih.gov

Influence of delivery devices on efficacy of inhaled fluticasone propionate: a comparative study in stable asthma patients. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Inhaled fluticasone propionate: a review of its therapeutic efficacy at dosages [2018]

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

Efficacy of inhaled fluticasone propionate in asthma results from topical and not from systemic activity. [2015]

6. England pubmed.ncbi.nlm.nih.gov

An open study to assess the long-term safety of fluticasone propionate in asthmatic children. International Study Group. [2015]

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

Effect of ciclesonide and fluticasone on hypothalamic-pituitary-adrenal axis function in adults with mild-to-moderate persistent asthma. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Growth and adrenal suppression in asthmatic children treated with high-dose fluticasone propionate. [2019]

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

Asthma: the role of fluticasone propionate. [2015]

10. United States 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. [2019]

11. Spain pubmed.ncbi.nlm.nih.gov

Pharmacology of fluticasone propionate. [2015]

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

Fluticasone propionate aerosol for the treatment of adults with mild to moderate asthma. The Fluticasone Propionate Asthma Study Group. [2019]