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).
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).
Published Studies Related to Serevent (Salmeterol Xinafoate)
Predictors of response to tiotropium versus salmeterol in asthmatic adults. 
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.
Clinical Trials Related to Serevent (Salmeterol Xinafoate)
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
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.
Chronic Obstructive Pulmanary Disease (COPD) Post-hospitalization Study [Not yet recruiting]
This trial is a randomized, double-blind, parallel-group, multicenter study to be conducted
in the United States. The purpose of the study is to evaluate the rate of exacerbations of
chronic obstructive pulmonary disease (COPD) following hospital discharge for an acute
exacerbation of COPD, in patients receiving either fluticasone propionate/salmeterol
combination product 250/50mcg BID or salmeterol 50mcg BID via DISKUSâ„˘ over 29 weeks. The
study population will include patients hospitalized for an acute exacerbation of COPD. The
target enrolment is 720 subjects at 80 study centers. The primary endpoint is the rate of
exacerbation requiring hospitalization that occur more than 21 days post-discharge,
emergency room visit or physician's office visit for an exacerbation of COPD requiring
treatment with oral corticosteroids or oral corticosteroids and antibiotics. The secondary
endpoint is the rate of COPD exacerbation requiring treatment with oral corticosteroids,
antibiotics, and/or hospitalization (alone and in combination). Related efficacy endpoints
include, time to first exacerbation of COPD requiring treatment with oral corticosteroids,
antibiotics, and/or hospitalization (alone and in combination), pre-dose AM FEV1, the
probability of premature withdrawal of subject from the study, and supplemental albuterol
use, change in biomarkers of inflammation, including, surfactant protein D (SP-D), clara
cell secretory protein 16 (CC-16) and high sensitivity C-reactive protein (hs-CRP). Health
outcome assessments include domain scores evaluation for fatigue, dyspnea, emotional
function and mastery, measured with the Chronic Respiratory Disease Questionnaire
self-administered standardized format (CRQ-SAS); and symptoms (congestion, cough, phlegm,
mucus, chest discomfort, shortness of breath and sleep disturbance), assessed by the
EXAcerbations of Chronic pulmonary disease Tool (EXACT). Albuterol will be supplied to
study subjects for use as-needed throughout the study. Safety will be assessed by
monitoring of adverse events.
Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients [Recruiting]
This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small
airways physiological parameters in COPD patients.
How Different Beta-2 Receptor Genotypes Affect an Asthmatic's Response to Regular Salmeterol Treatment [Recruiting]
The purpose of the study is to find out how well a long-acting beta agonist like salmeterol
works in people with different forms of the same gene. Our hypothesis is that asthmatics
with the Arg/Arg genotype will have loss of bronchoprotection against exercise-induced
asthma with regular salmeterol treatment, as compared to asthmatics with the Gly/Gly
Reports of Suspected Serevent (Salmeterol Xinafoate) Side Effects
Product Quality Issue (32),
Drug Ineffective (11),
Oropharyngeal Pain (5),
Atrial Fibrillation (5),
Choking (5), more >>
Page last updated: 2014-11-30