Fluticasone Propionate/Albuterol Sulfate for Asthma
Recruiting in Palo Alto (17 mi)
+29 other 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.
12345Is 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.
678910What 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.
1231112Eligibility 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.
+1 more
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)
Participant Groups
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.
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Fp/ABS eMDPIExperimental Treatment1 Intervention
Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module
Group II: Fp eMDPIActive Control1 Intervention
Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)
Group III: ABS eMDPIActive Control1 Intervention
Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)
Group IV: Placebo eMDPIPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Teva Investigational Site 12085Raleigh, NC
Teva Investigational Site 12090Dallas, TX
Teva Investigational Site 12068La Palma, CA
Teva Investigational Site 12082Salt Lake City, UT
More Trial Locations
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Who Is Running the Clinical Trial?
Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
References
Fluticasone propionate improves quality of life in patients with asthma requiring oral corticosteroids. [2015]Fluticasone propionate is a potent inhaled corticosteroid that is effective in improving pulmonary function and symptoms in patients with asthma.
Diskus and diskhaler: efficacy and safety of fluticasone propionate via two dry powder inhalers in subjects with mild-to-moderate persistent asthma. [2018]Fluticasone propionate is a topically active glucocorticoid with potent antiinflammatory activity in the treatment of asthma.
Influence of delivery devices on efficacy of inhaled fluticasone propionate: a comparative study in stable asthma patients. [2021]Inhaled corticosteroids are the preferred treatment for long-term control of all grades of persistent asthma. These are administered by various delivery devices with very little information whether these devices can affect the efficacy of inhaled corticosteroids. Fluticasone propionate is a relatively new inhalational corticosteroid compared to older ones like beclomethasone and budesonide. Aims & Objective: To assess the relative efficacy of fluticasone propionate administered from different delivery devices to adult patients of chronic stable bronchial asthma as measured by pulmonary function test parameters.
Inhaled fluticasone propionate: a review of its therapeutic efficacy at dosages [2018]Fluticasone propionate is a corticosteroid with comparatively high receptor affinity and topical activity. Inhaled fluticasone propionate
Efficacy of inhaled fluticasone propionate in asthma results from topical and not from systemic activity. [2015]The objective of this study was to determine whether the therapeutic benefits of inhaled fluticasone propionate are mediated through topical or systemic effects. Two hundred seventy-four patients with asthma receiving beclomethasone dipropionate or triamcinolone acetonide during a 2-wk, single-blind, run-in period were randomized to inhaled fluticasone propionate powder 100 or 500 micrograms twice daily, oral fluticasone propionate 20 mg once daily, or placebo during a 6-wk treatment period. Patients receiving inhaled fluticasone propionate had a significantly greater probability of remaining in the study over time compared with patients receiving oral fluticasone propionate or placebo (p = 0.001). FEV1 and PEF rates at end point were significantly higher with inhaled fluticasone propionate treatment regimens than with oral fluticasone propionate (with the exception of PEF rates for inhaled fluticasone propionate 100 micrograms) or placebo treatments (p
An open study to assess the long-term safety of fluticasone propionate in asthmatic children. International Study Group. [2015]This study was conducted to assess the long-term safety of fluticasone propionate 50 micrograms twice daily (100 micrograms/day) or 100 micrograms twice daily (200 micrograms/day) administered via a dry powder inhaler in children aged 4-17 years with moderately severe asthma. A total of 257 patients received open treatment for 12 months. Of these, 110 had not received treatment with fluticasone propionate in any prior study. The remaining 147 patients had completed one of two previous short-term inhaled fluticasone propionate studies. In all, 132 patients (51%) reported 273 adverse events, the pattern of which was as expected in an atopic population with asthma; only 26 (10%) of these reports were considered either certainly, probably or possibly related to study treatment. The events most commonly reported either as a single or multiple diagnosis were: asthma and related events (25%), upper respiratory tract infection (13%), and rhinitis (6%). For most patients who reported a worsening of asthma, additional therapy was all that was required to control symptoms, and they continued in the study. There was a low incidence (2%) of pharmacologically predictable adverse events. Eight patients (3%) withdrew from the study because of an adverse event, five of which events (one each of hypertension, hoarseness and asthma and two of oral candidiasis) were recorded as being possibly or probably drug-related. Sixteen adverse events reported by 15 patients (6%) were classified as serious but none was considered to be related to the study drug. Of these reports 10 ( patients; 4%) were exacerbations of asthma requiring hospital admission; the other six adverse events were unrelated to asthma.(ABSTRACT TRUNCATED AT 250 WORDS)
Effect of ciclesonide and fluticasone on hypothalamic-pituitary-adrenal axis function in adults with mild-to-moderate persistent asthma. [2022]Despite their proven efficacy in the treatment and prevention of asthma exacerbations, current inhaled corticosteroids carry safety concerns, especially adrenal suppression. Ciclesonide (hydrofluoroalkane propellant) is a novel inhaled corticosteroid with few, if any, clinical adverse events.
Growth and adrenal suppression in asthmatic children treated with high-dose fluticasone propionate. [2019]Fluticasone propionate was introduced in 1993 in the UK as a potentially safer inhaled corticosteroid than those already in use. The efficacy and safety of fluticasone has been established at recommended doses of 200 micrograms/day, but not at higher doses that are often used.
Asthma: the role of fluticasone propionate. [2015]This report reviews the evidence for the role of fluticasone propionate in the management of asthma, based on efficacy and safety trial data in over 4000 adults and more than 1600 children suffering from asthma of varying severity. Overall, fluticasone propionate at half the daily dose is at least as effective as budesonide and as effective as beclomethasone dipropionate across a range of doses.
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]To evaluate and contrast the therapeutic effect and safety of fluticasone aerosol combined with theophylline tablets in patients with moderate to severe asthma, compared with salmeterol/fluticasone propionate aerosol.
Pharmacology of fluticasone propionate. [2015]Fluticasone propionate is a novel inhaled corticosteroid which has the interesting properties of a high activity combined with low gastrointestinal absorption and rapid liver metabolism. On theoretical grounds, this drug might be expected to serve as a good antiinflammatory agent in asthma, while at the same time causing minimal systemic side effects.
Fluticasone propionate aerosol for the treatment of adults with mild to moderate asthma. The Fluticasone Propionate Asthma Study Group. [2019]Recent emphasis on the control of airway inflammation in asthma highlights the need for safe and effective antiinflammatory agents. Fluticasone propionate is one of the most potent antiinflammatory corticosteroids developed to date.