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Serevent (Salmeterol Xinafoate) - Summary



Data from a large placebo-controlled us study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to usual asthma therapy showed a small but significant increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks) versus those on placebo (3 of 13,179) (see WARNINGS and CLINICAL TRIALS: Asthma: Salmeterol Multi-center Asthma Research Trial).



(salmeterol xinafoate)
Inhalation Aerosol
Bronchodilator Aerosol
For Oral Inhalation Only

SEREVENT (salmeterol xinafoate) Inhalation Aerosol 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 (salmeterol xinafoate) Inhalation Aerosol is indicated for the following:


SEREVENT Inhalation Aerosol 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 12 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 should not be used in patients whose asthma can be managed by occasional use of inhaled, short-acting beta2-agonists.

SEREVENT Inhalation Aerosol may be used alone or in combination with inhaled or systemic corticosteroid therapy.

SEREVENT Inhalation Aerosol is also indicated for prevention of exercise-induced bronchospasm in patients 12 years of age and older.

Chronic Obstructive Pulmonary Disease

SEREVENT Inhalation Aerosol is indicated for long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with COPD (including emphysema and chronic bronchitis).

See all Serevent indications & dosage >>


Published Studies Related to Serevent (Salmeterol Xinafoate)

Predictors of response to tiotropium versus salmeterol in asthmatic adults. [2013]
corticosteroid, as well as predictors of a positive clinical response... CONCLUSION: Although these results require confirmation, predictors of a positive

Effect of fluticasone propionate/salmeterol on arterial stiffness in patients with COPD. [2011.09]
BACKGROUND: COPD is associated with increased arterial stiffness which may in part explain the cardiovascular morbidity observed in the disease. A causal relationship between arterial stiffness and cardiovascular events has not been established, though their strong association raises the possibility that therapies that reduce arterial stiffness may improve cardiovascular outcomes. Prior studies suggest that fluticasone propionate/salmeterol (FSC) may improve cardiovascular outcomes in COPD and we hypothesized that FSC would reduce arterial stiffness in these patients... CONCLUSION: FSC does not reduce aPWV in all patients with moderate to severe COPD, but may have effects in those with elevated arterial stiffness. Additional studies are required to determine if aPWV could serve as a surrogate for cardiovascular events in COPD. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16-Arg/Arg patients with asthma. [2011.08]
BACKGROUND: The efficacy and safety of inhaled long-acting beta(2)-adrenergic agonists in asthmatic patients with the B16-Arg/Arg genotype has been questioned, and the use of antimuscarinics has been proposed as an alternative in patients whose symptoms are not controlled by inhaled corticosteroids (ICSs). OBJECTIVE: We compared the efficacy and safety of the long-acting anticholinergic tiotropium with salmeterol and placebo added to an ICS in B16-Arg/Arg patients with asthma that was not controlled by ICSs alone... CONCLUSION: Tiotropium was more effective than placebo and as effective as salmeterol in maintaining improved lung function in B16-Arg/Arg patients with moderate persistent asthma. Safety profiles were comparable. Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

[Cost effectiveness of treatment with salmeterol/fluticasone compared to montelukast for the control of persistent asthma in children]. [2011.07]
OBJECTIVE: To assess the incremental cost-effectiveness of SFC compared with MON for the control of persistent asthma in children... CONCLUSIONS: This analysis demonstrates that, compared with MON, SFC may be cost saving from the Mexican health care perspective for the treatment of pediatric patients with asthma. SFC provided a reduction in the number of severe exacerbations, frequent asthma symptoms and rescue medication use. Incremental cost-effectiveness analysis indicated the dominance of SFC because of both lower costs and greater efficacy. Copyright (c) 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: a 12-week study. [2011.05]
BACKGROUND: Indacaterol is a novel, inhaled once-daily ultra-long-acting beta(2)-agonist for the treatment of COPD... CONCLUSION: Once-daily indacaterol provided statistically superior bronchodilation with an improvement in breathlessness and rescue use compared with twice-daily salmeterol. ClinicalTrials.gov NCT00821093. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

more studies >>

Clinical Trials Related to Serevent (Salmeterol Xinafoate)

Sunovion Brovana Versus Serevent Inspiratory Capacity High Resolution Computed Tomography [Recruiting]
This is a PI-initiated study taking place only at UCLA, sponsored by Sunovion. The investigators plan to enroll about 20 subjects who are at least 40 years old and have Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to compare the effectiveness of Brovana and Serevent in helping relieve COPD symptoms. Specifically, the investigators are looking at how much and for how long the two drugs can open up the small airways in the lungs. This will be done with breathing tests on all subjects, and with high resolution CT scans on subjects who agree to this optional part of the study. Half of subjects will take Brovana (arformoterol tartrate inhalation solution) for 2 weeks and then Serevent (salmeterol xinafoate inhalation powder) for 2 weeks; the other half will take Serevent the first two weeks and Brovana the second two weeks. All subjects will also take Spiriva (tiotropium) and will be provided with albuterol for immediate relief of symptoms. After a Screening Visit to determine eligibility, subjects will be randomly assigned to receive Brovana or Serevent for the first 2 weeks, complete Test Visit 1, then receive the other study drug for 2 weeks, and finally complete Test Visit 2. Visits will include questionnaires, review of health and medications, and breathing tests before and after taking the study drug. Subjects who agree to be in the sub-study will also undergo CT scans before and after taking the study drug at both test visits.

Effect of Salmeterol on Fluid Clearance From Alveolar-Capillary Membrane in COPD Patients [Completed]
The cardiovascular component associated with COPD plays a major role in prognosis of the disease, being responsible of 25% of the deaths. Experimental and initial clinical data suggest that beta-adrenergic agonists accelerate clearance of excess fluid from the alveolar airspace, with potential positive effect on cardiogenic pulmonary edema. The aim of this study was to investigate the effects of a long-acting beta-2 agonist, salmeterol, on alveolar fluid clearance in COPD patients by evaluating the diffusive and mechanical lung properties. Our experimental model to test alveolar fluid clearance was rapid saline intravenous infusion. Ten COPD and 10 healthy subjects treated with salmeterol or placebo 4 hours before the begin of the study were evaluated, in four non consecutive days, just before and after a saline infusion or a similar period without infusion. Both in COPD and healthy subjects rapid saline infusion, with placebo or salmeterol premedication, lead to a significant decrease of DLCO and FEV1. Nonetheless, salmeterol pretreatment lead to a significant reduction of the impairment of gas exchange due to saline infusion (-64% of DLCO reduction in comparison with placebo), whilst it did not affect the changes in FEV1. In the control setting, with no infusion, we did not find any significant change of both DLCO and mechanical properties of the lung. In conclusions, in COPD patients salmeterol appears to provide a protective effect against an acute alveolar fluid clereance challenge secondary to lung fluid overload providing an intriguing mechanistic explanation for the benefits observed in larger trials.

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.

A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149 [Completed]
To demonstrate the non-inferiority of QVA149 110/50 µg o. d. to fluticasone/salmeterol 500/50 µg b. i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD

A Study in Patients With Moderate Asthma to Compare Pharmacokinetics and Pharmacodynamic Effects of Fluticasone Propionate and Salmeterol Delivered Via the ROTAHALER® Inhaler Relative to the DISKUS® Inhaler [Withdrawn]
The Fluticasone Propionate/Salmeterol combination (FSC) at a dose of 100/50 micrograms (mcg) twice daily in DISKUS inhaler (also known as ACCUHALER®, Ddpi) inhaler is a recognised and licensed therapy for the treatment of asthma. GlaxoSmithKline (GSK) is developing the ROTAHALER/ ROTACAPS® (Rdpi) inhaler as an alternative treatment option for asthmatic patients. This study is a Phase I, randomised, double-blind, double-dummy, two- treatment, four-way cross-over (replicate design), two sequence, repeat dose, two centre study in mild to moderate asthmatics to compare the pharmacokinetics and pharmacodynamics of fluticasone proprionate/salmeterol (100/50 mcg) delivered via the Rdpi versus the Ddpi. A total of 58 subjects will be enrolled to ensure 52 subjects complete all dosing occasions. Each subject will be allocated to one of two treatment sequences and will participate in four treatment periods, receiving each of the treatments twice. DISKUS, ACCUHALER, ROTAHALER and ROTACAPS are registered trademarks of GSK groups of companies.

more trials >>

Reports of Suspected Serevent (Salmeterol Xinafoate) Side Effects

Product Quality Issue (32)Dyspnoea (20)Asthma (17)Drug Ineffective (11)Wheezing (6)Cough (6)Oropharyngeal Pain (5)Overdose (5)Atrial Fibrillation (5)Choking (5)more >>

Page last updated: 2014-11-30

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