SUMMARY
SEREVENT DISKUS (salmeterol xinafoate inhalation powder) contains salmeterol xinafoate as the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The active component of the formulation is salmeterol base, a highly selective beta2-adrenergic bronchodilator.
SEREVENT DISKUS is indicated for the following:
Asthma: SEREVENT DISKUS is indicated for long-term, twice-daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma, who require regular treatment with inhaled, short-acting beta2-agonists. It is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting beta2-agonists.
SEREVENT DISKUS is also indicated for prevention of exercise-induced bronchospasm in patients 4 years of age and older.
SEREVENT DISKUS may be used alone or in combination with inhaled or systemic corticosteroid therapy.
Chronic Obstructive Pulmonary Disease: SEREVENT DISKUS is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with COPD (including emphysema and chronic bronchitis).
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NEWS HIGHLIGHTS
Published Studies Related to Serevent Diskus (Salmeterol Inhalation Powder)
Add-on salmeterol compared to double dose fluticasone in pediatric asthma: A double-blind, randomized trial (VIAPAED). [2009.10.12]
RATIONALE: In asthmatic children whose symptoms are uncontrolled on standard doses of inhaled corticosteroids (ICS), guidelines recommend to either increase the ICS dose or to add further controller medication, e.g. a long acting ss2-agonist (LABA). The aim of this study was to compare the efficacy and safety of doubling the dose of ICS (fluticasone proprionate FP 200 microg twice daily) with adding a long-acting beta-2 agonist to the ICS (SFC, salmeterol 50 microg/ FP 100 microg twice daily) in children with uncontrolled asthma... CONCLUSIONS: In children with persistent asthma inadequately controlled on low dose ICS alone, adding a long acting beta-2-agonist to ICS in a single inhaler was more effective than doubling the ICS dose. These results support recommendations of adding LABA to low-dose ICS as the preferred controller option for children older than 4 years with symptomatic asthma. Pediatr Pulmonol. (c)2009 Wiley-Liss, Inc.
Childhood evaluation of salmeterol tolerance - A double-blind randomized controlled trial. [2009.08.27]
Carroll WD, Jones PW, Boit P, Clayton S, Cliff I, Lenney W...
Fluticasone propionate/salmeterol and exercise-induced asthma in children with persistent asthma. [2009.05]
RATIONALE: Exercise is a common trigger in children with persistent asthma and inhaled corticosteroids have been shown to effectively treat clinical manifestations of persistent asthma, including protection from decrements in lung function caused by exercise. The goal of this study was to evaluate the effectiveness of fluticasone propionate/salmeterol 100/50 mcg compared with fluticasone propionate 100 mcg for the prevention of airflow limitation triggered by standardized exercise challenge in pediatric and adolescent patients with persistent asthma... CONCLUSION: Chronic dosing with fluticasone propionate/salmeterol in a single device provides superior protection compared with an inhaled corticosteroid alone in protecting against exercise-induced asthma in children with persistent asthma. (c) 2009 Wiley-Liss, Inc.
Efficacy and tolerability of salmeterol/fluticasone propionate versus montelukast in childhood asthma: A prospective, randomized, double-blind, double-dummy, parallel-group study. [2008.08]
BACKGROUND: Asthma control remains suboptimal in adults and children worldwide. Inhaled salmeterol/fluticasone propionate combination (SFC) and oral montelukast (MON) are 2 treatments available for childhood asthma. OBJECTIVE: This study, the PEdiatric Asthma Control Evaluation (PEACE), investigated the efficacy and tolerability of SFC compared with MON for the control of persistent asthma in children... CONCLUSIONS: In these children with uncontrolled asthma previously on short-acting beta(2)-agonist monotherapy (% predicted FEV(1) <80%, frequent asthma symptoms and rescue medication use), treatment with SFC was significantly more effective in improving morning PEF and other measures of asthma control and in decreasing exacerbation rates (in a post hoc analysis) than treatment with MON. The 2 drugs were both well tolerated, with similar numbers and types of AEs reported.
Early bronchodilatory effects of budesonide/formoterol pMDI compared with fluticasone/salmeterol DPI and albuterol pMDI: 2 randomized controlled trials in adults with persistent asthma previously treated with inhaled corticosteroids. [2008.05]
Two identically designed, randomized, multicenter, single-dose, crossover studies were conducted in patients aged > or = 18 years with mild to moderate asthma previously treated with inhaled corticosteroids. After 2 weeks on twice-daily budesonide pressurized metered-dose inhaler (pMDI) 160 microg, patients received a randomized sequence of budesonide/formoterol pMDI 80/4.5 microg x 2 inhalations (160/9 microg), fluticasone/salmeterol dry powder inhaler (DPI) 250/50 microg x 1 inhalation, albuterol pMDI 90 microg x 2 inhalations (180 microg), and placebo pMDI (3-to 14-day washout periods)...
Clinical Trials Related to Serevent Diskus (Salmeterol Inhalation Powder)
Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate [Completed]
This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood
sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done
during the study. Study medicines and procedures will be provided at no cost. Patients will
be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR
and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and
older.
Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics [Completed]
A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone
propionate and salmeterol was compared with concurrent administration of fluticasone
propionate and salmeterol. Administration occurred over 14 days and tolerability, PK
(pharmacokinetic) and PD (pharmacodynamic) measurements were performed.
ADVAIR DISKUS (Fluticasone Propionate/Salmeterol) Versus SEREVENT DISKUS (Salmeterol) On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease [Terminated]
This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary
Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will
stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic.
Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study
visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have
breathing tests and will complete diary cards during the study. All study medicines and
examinations will be given at no cost to the study subjects. Both medicines used in this
study have been approved by the US FDA.
AdvairŪ DISKUSŪ (Fluticasone Propionate/Salmeterol) Versus SereventŪ DISKUSŪ (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations [Completed]
This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary
Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the
clinic 10 times. Subjects will be given breathing tests and will record their breathing
symptoms daily on diary cards. All study related medicines and medical examinations will be
provided at no cost. The two drugs used in this study have been approved by the FDA for use
in patients with COPD.
Effects of Salmeterol on Walking Capacity in Patients With COPD [Completed]
This study was designed to test the following hypothesis:
The acute changes in exercise tolerance during the endurance shuttle walk will be greater
with salmeterol compared to placebo in patients with chronic obstructive pulmonary disease.
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Page last updated: 2009-10-20
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