Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: A randomized, double-blind, placebo-controlled trial

Kavuru, Mani S.; Melamed, Julian; Gross, Gary N.; LaForce, Craig; House, Karen; Prillaman, Barbara A.; Baitinger, Leslie; Woodring, Anita; Shah, Tushar

doi:10.1067/mai.2000.105711

Cited by 221 publications

(118 citation statements)

References 18 publications

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“…The observed lower risk of this asthma-related morbidity in the FSC cohort may be due to the greater efficacy noted in the clinical trials [12][13][14] and increased compliance noted in observational studies. 18,19 The less frequent observation of switching controller medication seen with FSC may reflect patient preference associated with both the better outcomes and ease of administration.…”

Section: Discussionmentioning

confidence: 93%

“…9 These results support previous clinical trial findings that demonstrate the superiority of FSC compared with therapy with FP, SAL, or FP ϩ SAL. [12][13][14] Asthma exacerbations that result in asthma-related ED visits or hospitalization episodes are one of the major cost drivers for asthma. 4,6 Most clinical trials are not powered to detect changes in the rates of exacerbations.…”

Section: Discussionmentioning

confidence: 99%

“…8 -11 The present study was designed to evaluate whether the better clinical outcomes noted in randomized trials that favored fluticasone propionate and salmeterol as a single inhaler (FSC) compared with fluticasone propionate alone (FP) and fluticasone propionate plus salmeterol dispensed as separate inhalers (FP ϩ SAL) would be noted in observational studies. [12][13][14] Outcome parameters used to evaluate effectiveness of therapy included postindex exacerbations indicated by administrative claims for ED or hospital utilization, loss of symptom control evaluated by the filling of prescriptions for albuterol or other short-acting ␤-agonists (SABAs), and switch or discontinuation of controller medication.…”

Section: Introductionmentioning

confidence: 99%

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Asthma-related exacerbations, therapy switching, and therapy discontinuation: a comparison of 3 commonly used controller regimens

O’Connor

Rosenzweig

Stanford

et al. 2005

Annals of Allergy, Asthma & Immunology

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Background: Asthma control is the goal of therapeutic interventions. In observational studies, the use of short-acting ␤-agonists (SABAs) is a surrogate for symptoms and emergency department or hospital events for exacerbations.Objective: To compare asthma exacerbations, medication switch, and use of SABAs among 3 treatment cohorts: fluticasone propionate and salmeterol as a single inhaler (FSC), fluticasone and salmeterol as separate inhalers (FP ϩ SAL), and fluticasone propionate alone (FP).Methods: Administrative claims data from approximately 10 million individuals from April 2000 to December 2002 were examined. Patients 15 years or older with claims for asthma, SABAs, and study medications were included in the study. Asthma-related medical and pharmacy claims were evaluated. Multivariate regression techniques were used to model the outcomes of interest, controlling for patient characteristics.Results: The odds of a hospitalization or emergency department event were significantly lower for the patients receiving FSC (n ϭ 1,013) compared with those receiving FP (n ϭ 1,130) (odds ratio, 0.75; 95% confidence interval, 0.61-0.93) and those receiving FP ϩ SAL (n ϭ 271) (odds ratio, 0.69; 95% confidence interval, 0.51-0.95). Patients receiving FSC also had a significantly lower risk of switch or discontinuation of index medication and lower rates of postindex SABA use.Conclusion: In this analysis, patients receiving FSC had lower rates of asthma-related symptoms and exacerbations as measured by SABA refills and hospitalization, respectively, when compared with patients receiving either FP or FP ϩ SAL. This observational examination of medical and pharmacy claims data adds to the clinical reports that demonstrate the increased effectiveness of FSC when compared with FP or FP ϩ SAL.Ann Allergy Asthma Immunol. 2005;95:535-540.

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Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Asthma-related exacerbations, therapy switching, and therapy discontinuation: a comparison of 3 commonly used controller regimens

O’Connor

Rosenzweig

Stanford

et al. 2005

Annals of Allergy, Asthma & Immunology

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“…Greater improvements were seen with salmeterol/fluticasone propionate versus fluticasone propionate alone and this finding is consistent with those of previous studies. [6][7][8] The differences seen between the treatment arms were clinically significant and the improvements seen in percentage of symptom-free days are of particular note. Overall, combination therapy provided an additional 66 symptom-free days per year when compared with fluticasone propionate alone, and in all strata, symptom-free days and rescue-free days were more probable in patients receiving combination therapy than in patients receiving fluticasone propionate alone.…”

Section: Discussionmentioning

confidence: 91%

Improvement in asthma endpoints when aiming for total control: salmeterol/fluticasone propionate versus fluticasone propionate alone

Woodcock

Bagdonas

Boonsawat

et al. 2007

Primary Care Respiratory Journal

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Aims: To investigate the magnitude of change in morning peak expiratory flow (PEF), asthma symptoms, and rescue β2-agonist use, when the aim of treatment is to achieve guideline-defined control.Methods: This was a protocol-defined analysis of data from the previously-reported one-year, stratified, randomised, double-blind, parallel-group GOAL study comparing the use of salmeterol/fluticasone propionate with fluticasone propionate alone in achieving guideline-defined control; this analysis assessed the magnitude of change in single specific endpoints which were amalgamated into the composite measure of control used in the primary GOAL analysis.Results: Across all strata, improvements were seen for each outcome at 52 weeks as compared to baseline: mean morning PEF, 58.2 l/min (salmeterol/fluticasone propionate) versus 33.9 l/min (fluticasone propionate alone); symptom scores, -1.0 versus -0.8; symptomfree days, 72.5% versus 54.5%; mean of zero night awakenings, 31% versus 22%; rescue-free days, 87.3 versus 74.7; annualised rate of severe exacerbations, 0.02 versus 0.03; p<0.001 for all treatment differences.Conclusions: Aiming for guideline-defined control resulted in sustained, clinically relevant improvements in a range of individual asthma outcomes. Improvements were greatest with salmeterol/fluticasone propionate versus fluticasone propionate alone. IntroductionThe Global Asthma Insights and Reality (AIR) surveys showed that levels of asthma control worldwide fall far short of the goals set out by the Global Initiative for Asthma (GINA). 1,2 The one-year Gaining Optimal Asthma controL (GOAL) study investigated the benefits of aiming for comprehensive, guideline-defined control of asthma in patients with suboptimal control. In the GOAL study, guideline-defined asthma control was assessed over eight-week periods using two composite measures derived from the stringent criteria specified in the GINA and National Institutes of Health guidelines. 1,3 'Total Control' was defined as none of the following for at least seven out of eight weeks: daytime symptoms; use of rescue medication; night-time awakenings; exacerbations; emergency visits; or treatment-related adverse events enforcing a change in therapy. In addition, patients had to have a morning peak expiratory flow (PEF) of >80% predicted for every day of the eight weeks. For 'Well Copyright GPIAG -Reproduction prohibited C o p y r i g h t G e n e r a l P r a c t i c e A i r w a y s G r o u p R e p r o d u c t i o n P r o h i b i t e dAA Woodcock et al. 156Controlled' asthma, patients had to meet the same criteria as Total Control for night-time awakenings, exacerbations, emergency visits, and treatment-related adverse events.Patients also had to achieve two out of the following each week: <2 days with a daytime symptom score >1; <2 days and <4 occasions of rescue medication use; morning PEF >80% predicted every day. As previously reported, the results of the GOAL study showed that comprehensive, guideline-defined control can be achieved and maintained i...

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“…those requiring systemic corticosteroids), important insight into the efficacy of medications can be gained from analyzing related moderate exacerbation events characterized by a sustained loss of asthma control (beyond normal day-today variation) that does not meet the definition of a severe exacerbation. [2] For the purpose of asthma research protocol development, moderate exacerbation events have been captured using various terminology, such as asthma deterioration, [3] asthma worsenings, [4] and asthma events. [5] Few US studies have evaluated the safety and efficacy of an inhaled corticosteroid (ICS)/long-acting b 2 -adrenergic agonist (LABA) combination therapy in Black or Hispanic patients with asthma.…”

Section: Introductionmentioning

confidence: 99%

The Effect of Budesonide/Formoterol Pressurized Metered-Dose Inhaler on Predefined Criteria for Worsening Asthma in Four Different Patient Populations with Asthma

et al. 2012

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Background: Previous studies have shown disparities between Black and Hispanic patients compared with other populations in response to asthma medications. Objective: The aim of this analysis was to assess the effect of budesonide/ formoterol pressurized metered-dose inhaler (BUD/FM pMDI) and BUD on predefined criteria for asthma worsening, an asthma control metric generally aligned with definitions of moderate asthma exacerbations, across four different populations. Methods: Data were from four 12-week, randomized, double-blind, US studies of BUD/FM pMDI treatment in patients aged 12 years or older with varying asthma severities and of varying races. Predefined asthma events and withdrawals due to predefined events were assessed as secondary study endpoints. Study I (NCT00651651) includes data from predominantly White patients with mild to moderate asthma who were randomized to BUD/FM pMDI 160/9 mg twice daily (bid; n = 123) or BUD pMDI 160 mg bid (n = 121). Study II (NCT00652002) includes data from predominantly White patients with moderate to severe asthma who were randomized to BUD/FM pMDI 320/9 mg bid (n = 124) or BUD pMDI 320 mg bid (n = 109). Study III (NCT00702325) included self-reported Black patients with moderate to severe asthma who were randomized to BUD/FM pMDI 320/9 mg bid (n = 153) or BUD dry powder inhaler 360 mg bid (n = 148). Study IV (NCT00419757) included self-reported Hispanic patients with moderate to severe asthma who were randomized to BUD/FM pMDI 320/9 mg bid (n = 127) or BUD pMDI 320 mg bid (n = 123). Patients were to be withdrawn from the studies if they developed an asthma event, as determined by predefined criteria, except for night-time awakenings, where withdrawal was left to the study physician's judgment.

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Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: A randomized, double-blind, placebo-controlled trial

Cited by 221 publications

References 18 publications

Asthma-related exacerbations, therapy switching, and therapy discontinuation: a comparison of 3 commonly used controller regimens

Asthma-related exacerbations, therapy switching, and therapy discontinuation: a comparison of 3 commonly used controller regimens

Improvement in asthma endpoints when aiming for total control: salmeterol/fluticasone propionate versus fluticasone propionate alone

The Effect of Budesonide/Formoterol Pressurized Metered-Dose Inhaler on Predefined Criteria for Worsening Asthma in Four Different Patient Populations with Asthma

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