Inhaled Steroids/Long-Acting Bronchodilators for Asthma
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Gelb, Arthur F., M.D.
Must be taking: Inhaled corticosteroids, Long acting beta2agonists
Disqualifiers: Pregnancy
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the site and mechanisms responsible for expiratory airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to severe persistent expiratory airflow obstruction. Treatment will include inhaled corticosteroids and long acting beta2agonists. The investigators are interested in determining whether the large and/or small airways are the predominant site of airflow limitation. The investigators are also interested in determining whether intrinsic small airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow limitation. The investigators are also interested to evaluate the role of varying doses of inhaled corticosteroids to suppress large and small airway inflammation using exhaled nitric oxide as surrogate markers of inflammation. For comparison purposes, spirometry and measurements of exhaled nitric oxide will also be obtained if possible during a naturally occurring exacerbation of asthma.
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications. However, since it involves treatment with inhaled corticosteroids and long-acting bronchodilators, you may need to adjust your current asthma medications. Please consult with the trial coordinators for specific guidance.
What data supports the effectiveness of the drug Budesonide/Formoterol, Fluticasone/Salmeterol, Advair, Seretide, AirDuo Respiclick, Fluticasone Propionate/Salmeterol Xinafoate for asthma?
Research shows that the combination of fluticasone propionate and salmeterol (found in drugs like Advair and Seretide) is effective in improving lung function and asthma symptoms more than using inhaled corticosteroids alone. It is also well tolerated and cost-effective for maintaining asthma control.
12345Is the combination of inhaled steroids and long-acting bronchodilators safe for asthma patients?
Studies show that using inhaled steroids with long-acting bronchodilators, like budesonide/formoterol, is generally safe for asthma patients. Common side effects include oral thrush (a mouth infection), tremors, and throat pain, but serious issues are rare. Long-term use has not shown significant safety concerns, and it may even reduce asthma flare-ups.
678910How does the drug Budesonide/Formoterol differ from other asthma treatments?
Budesonide/Formoterol is a combination of an inhaled steroid and a long-acting bronchodilator, which helps to control asthma symptoms by reducing inflammation and relaxing the muscles around the airways. It is similar to Fluticasone/Salmeterol, but studies suggest that Fluticasone/Salmeterol may provide better asthma control and lung function improvement in some patients.
1341112Eligibility Criteria
This trial is for stable, treated asthmatics aged 10-80 who are current non-smokers with a minimal smoking history. Participants should have specific levels of lung function reduction after using albuterol. Pregnant individuals cannot participate.Inclusion Criteria
I am between 10 and 80 years old.
My lung function tests show severe asthma or COPD.
My asthma is under control with treatment.
+1 more
Exclusion Criteria
Pregnancy
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive inhaled corticosteroids and long-acting beta2 agonists to evaluate airflow limitation mechanisms
8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including spirometry and exhaled nitric oxide measurements
4 weeks
Long-term Observation
Long-term observation to evaluate mechanisms of expiratory airflow limitation and presence of emphysema
1-5 years
Participant Groups
The study tests the effects of two inhaled treatments: budesonide/formoterol and fluticasone/salmeterol on airflow limitation in asthma patients. It aims to identify which airways are affected and how inflammation can be reduced using different doses.
1Treatment groups
Experimental Treatment
Group I: Asthma observational study armExperimental Treatment2 Interventions
Asthmatics in this arm may be on varying dose of inhaled fluticasone 100-500mcg/salmeterol 50mcg bid via Advair MDI or equivalent dose via Diskus bid or Symbicort (budesonide 80-160mcg/formoterol 4.5mcg bid)or Dulera 100-200mcg mometasone/5 mcg formoterol bid, tiotropium 18mcg capsule daily. This is an observational study and additional pharmacologic intervention may include antibiotic and tapering doses of corticosteroids.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Arthur F Gelb Medical CorporationLakewood, CA
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Who Is Running the Clinical Trial?
Gelb, Arthur F., M.D.Lead Sponsor
References
Inhaled salmeterol/fluticasone propionate: a review of its use in asthma. [2021]Salmeterol/fluticasone propionate, administered twice daily via a multidose dry powder inhaler (Seretide/Advair Diskus), Seretide Accuhaler or metered-dose hydrofluoroalkane (chlorofluorocarbon-free) inhaler (Seretide Evohaler), is a combination of the long-acting beta(2)-adrenoceptor agonist (beta(2)-agonist) [LABA] salmeterol and the corticosteroid fluticasone propionate. Maintenance therapy with combined salmeterol/fluticasone propionate is at least as effective in improving lung function and symptoms and is as well tolerated in patients with asthma as concurrent salmeterol plus fluticasone propionate. In patients previously receiving as-required short-acting beta(2)-agonists (SABAs) or inhaled corticosteroids, salmeterol/fluticasone propionate was significantly more effective in providing asthma control than fluticasone propionate and in improving lung function and asthma symptoms than inhaled corticosteroids (at equivalent or higher dosages), salmeterol or montelukast (as monotherapy or in combination with fluticasone propionate). Salmeterol/fluticasone propionate was more effective in improving asthma symptoms than adjusted-dose budesonide/formoterol in patients with uncontrolled asthma despite treatment with inhaled corticosteroids with or without a LABA in a well designed 1-year study. In pharmacoeconomic analyses, salmeterol/fluticasone propionate compared favourably with inhaled corticosteroids and mono- or combination therapy with oral montelukast. Salmeterol/fluticasone propionate is, therefore, an effective, well tolerated and cost-effective option for the maintenance treatment of patients with asthma.
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. [2018]The present study was conducted to assess the efficacy, safety and tolerability of fluticasone propionate/formoterol fumarate combination therapy (FP/FORM; Flutiform®) compared with fluticasone propionate/salmeterol xinafoate (FP/SAL; Seretide® Evohaler®) in children with asthma.
Fluticasone propionate/salmeterol for the treatment of chronic-obstructive pulmonary disease. [2019]Chronic-obstructive pulmonary disease (COPD) is a global public health problem and its impact is increasing. Although only smoking cessation has been shown to alter the natural history of the disease, current treatment guidelines recommend the use of inhaled bronchodilators to decrease symptoms, improve lung function and quality of life and to prevent exacerbations. For a subset of patients with more severe disease, inhaled corticosteroids may also have a role in achieving these goals. Fluticasone propionate/salmeterol (Advair) or Seretide), GlaxoSmithKline) is a combination inhaled steroid and long-acting bronchodilator that is delivered by a dry-powder inhaler and was recently approved for use in COPD in the US. Fluticasone propionate/salmeterol is a potent bronchodilator and also appears to have important effects on the frequency of exacerbations and overall quality of life for some patients with COPD. Issues of patient selection as well as the pharmacology, efficacy and safety of the drug are discussed.
Salmeterol/fluticasone propionate: a review of its use in asthma. [2021]Salmeterol/fluticasone propionate (Seretide/Advair Diskus [dry powder inhaler] or Seretide/Advair inhalation aerosol [metered-dose inhaler]) is a fixed-dose combination inhalation agent containing a long-acting beta2-adrenoceptor agonist (LABA) plus a corticosteroid. In patients with symptomatic asthma, twice-daily salmeterol/fluticasone propionate maintenance therapy improves lung function and asthma symptoms to a greater extent than monotherapy with inhaled corticosteroids (ICS), such as fluticasone propionate, oral montelukast with or without fluticasone propionate, or sustained-release theophylline plus fluticasone propionate. The greater efficacy achieved with salmeterol/fluticasone propionate versus fluticasone propionate alone was sustained for 1 year in a well designed trial. Salmeterol/fluticasone propionate is also associated with a corticosteroid-sparing effect. Results of studies comparing fixed dosages of salmeterol/fluticasone propionate with formoterol/budesonide in adults and adolescents are equivocal. Twice-daily salmeterol/fluticasone propionate is associated with clinically meaningful improvements from baseline in health-related quality of life (HR-QOL), and improvements were greater than those reported with fluticasone propionate alone. Salmeterol/fluticasone propionate is generally well tolerated in adults, adolescents and children aged 4-11 years, and the fixed-combination inhaler ensures the appropriate use of a LABA in combination with an ICS. In cost-utility analyses in patients with uncontrolled asthma, salmeterol/fluticasone propionate compares favourably with fluticasone propionate alone or oral montelukast. Thus, salmeterol/fluticasone propionate provides an effective, well tolerated and cost-effective option for maintenance treatment in patients with asthma.
Superiority of fluticasone propionate/formoterol fumarate versus fluticasone propionate alone in patients with moderate-to-severe asthma: a randomised controlled trial. [2015]To demonstrate the efficacy and safety of fluticasone propionate/formoterol fumarate (flutiform) in a pressurised metered-dose inhaler (pMDI) compared to two formulations of the fluticasone propionate component (Skyepharma fluticasone [SKP FP] or Flovent, GlaxoSmithKline [GSK FP]) in adults and adolescents with moderate-to-severe asthma.
Budesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials. [2022]This analysis was designed to provide a comparison between budesonide/formoterol and salmeterol/fluticasone for the relative incidence of pneumonia adverse events, pneumonia serious adverse events and pneumonia-related mortality in patients being treated for chronic obstructive pulmonary disease.
Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial. [2022]Only a few studies directly compared the therapeutic efficacy and safety of two pressurized metered-dose inhalers (pMDIs) in asthma. We analyzed the asthma treatment outcomes, safety, and patient preferences using formoterol/beclomethasone (FORM/BDP), a pMDI with extra-fine particles, compared with formoterol/budesonide (FORM/BUD), another pMDI with non-extra-fine particles.
Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone. [2017]Concerns remain about the safety of adding long-acting β2-agonists to inhaled glucocorticoids for the treatment of asthma. In a postmarketing safety study mandated by the Food and Drug Administration, we evaluated whether the addition of formoterol to budesonide maintenance therapy increased the risk of serious asthma-related events in patients with asthma.
Long-term safety and asthma control with budesonide/formoterol versus budesonide pressurized metered-dose inhaler in asthma patients. [2022]Safety concerns have been raised regarding the regular use of long-acting beta(2)-adrenergic agonists (LABAs) alone or with inhaled corticosteroids (ICSs). The purpose of this study was to examine the long-term safety of budesonide/formoterol pressurized metered-dose inhaler (pMDI). This 52-week, double-blind study (SD-039-0728; n=708) included patients >or=12 years of age with moderate to severe persistent asthma previously receiving ICSs. After 2 weeks on budesonide pMDI 320 microg twice daily (b.i.d.), patients were randomized 3:1:1 overall to budesonide/formoterol pMDI 640/18 microg b.i.d., budesonide/formoterol pMDI 320/9 microg b.i.d., or budesonide pMDI 640 microg b.i.d. The incidence of adverse events (AEs) was similar across the groups. Drug-related AEs (>or=2% overall) were oral candidiasis, tremor, and pharyngolaryngeal pain. No clinically meaningful differences in laboratory, electrocardiogram, or Holter monitor variables were observed. The percentage of patients with >or=1 asthma exacerbation was significantly lower (p=0.006) with budesonide/formoterol 640/18 (12.2%) and numerically lower with budesonide/formoterol 320/9 (14.4%) versus budesonide (21.8%). The number of asthma exacerbations per patient-treatment year was lower with budesonide/formoterol 640/18 (0.174; p=0.004) and budesonide/formoterol 320/9 (0.185; p=0.049) versus budesonide (0.315). Improvements in forced expiratory volume in 1 second and diary variables were significantly greater (p
Efficacy and safety of fluticasone propionate/formoterol fumarate in pediatric asthma patients: a randomized controlled trial. [2019]Label="BACKGROUND">The efficacy and safety of fluticasone propionate/formoterol fumarate pressurized metered-dose inhaler (pMDI) (fluticasone/formoterol; Flutiform®; 100/10 µg b.i.d.) was compared with fluticasone propionate (Flixotide® Evohaler® pMDI; 100 µg b.i.d.) and fluticasone/salmeterol (Seretide® Evohaler® pMDI; 100/50 µg b.i.d.) in a pediatric asthma population (EudraCT number: 2010-024635-16).
Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children. [2020]Long-acting beta-agonists are a common second line treatment in people with asthma inadequately controlled with inhaled corticosteroids. Single device inhalers combine a long-acting beta-agonist with an inhaled steroid delivering both drugs as a maintenance treatment regimen. This updated review compares two fixed-dose options, fluticasone/salmeterol FP/SALand budesonide/formoterol, since this comparison represents a common therapeutic choice.
Onset of bronchodilation with fluticasone/formoterol combination versus fluticasone/salmeterol in an open-label, randomized study. [2017]The inhaled corticosteroid, fluticasone propionate (fluticasone), and the long-acting beta(2)-agonist, formoterol fumarate (formoterol), have been combined in a single aerosol inhaler (fluticasone/formoterol). In a randomized, open-label study, fluticasone/formoterol showed similar efficacy to fluticasone/salmeterol after 12 weeks of treatment. This post-hoc analysis compared the onset of bronchodilation with the two treatments.