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Serevent (Salmeterol Xinafoate) - Summary

 
 



WARNING

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).

 

SEREVENT SUMMARY

SEREVENT®
(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:

Asthma

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 >>

NEWS HIGHLIGHTS

Published Studies Related to Serevent (Salmeterol Xinafoate)

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.

Comparative lung bioavailability of fluticasone/salmeterol via a breath-actuated spacer and conventional plastic spacers. [2011.04]
PURPOSE: This study compares the in vivo relative lung bioavailability of Hydrofluoroalkane (HFA) Seretide delivered via unprimed and unwashed Aerochamber Plus (AP) or Volumatic (VM) spacers, a integrated breath-actuated vortex Synchro-Breathe (SB) device and an Evohaler pMDI (EH) device using adrenal suppression and early fall in serum potassium (K) as surrogates for respirable dose... CONCLUSIONS: The breath-actuated SB device was comparable to 'out of the box' small and large volume spacers and produced similar improvements in relative systemic lung bioavailability for fluticasone and salmeterol.

more studies >>

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 older.

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.

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 DISKUS™ 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.

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: 2011-12-09

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