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).
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SEREVENT SUMMARY
SEREVENTŪ
(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).
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NEWS HIGHLIGHTS
Published Studies Related to Serevent (Salmeterol Xinafoate)
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...
Effects of Salmeterol on Sleeping Oxygen Saturation in Chronic Obstructive Pulmonary Disease. [2009.08.14]
Background: Sleep is associated with important adverse effects in patients with chronic obstructive pulmonary disease (COPD), such as disturbed sleep quality and gas exchange, including hypoxemia and hypercapnia...
A novel breath-actuated integrated vortex spacer device increases relative lung bioavailability of fluticasone/salmeterol in combination. [2009.08]
BACKGROUND: Spacer devices facilitate respirable drug delivery. A novel breath-actuated antistatic spacer with integrated vortex chamber (Synchro-Breathe) device has been developed, which is compact,portable and user friendly as compared to conventional spacers which are bulky and cumbersome. The relative bioavailability to the lung of inhaled fluticasone and salmeterol combination is primarily dependent on respirable dose delivery and can be reliably quantified using adrenal suppression and early fall in serum potassium (marker of systemic beta-2 adrenoreceptor response) as surrogate markers for delivered lung dose. AIMS AND OBJECTIVES: To compare the in vivo relative bioavailability to the lung of Hydrofluoroalkane(HFA) Seretide delivered via Synchro-Breathe (SB); an optimally prepared 750 ml large volume plastic spacer, Volumatic (VM); and conventional Evohaler pMDI (EH)... CONCLUSION: The breath-actuated Synchro-Breathe device was comparable to an optimally prepared Volumatic spacer, and resulted in commensurate improvement in relative lung bioavailability for both fluticasone and salmeterol moieties compared to pMDI.
Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study. [2009.06.30]
BACKGROUND: The efficacy of inhaled salmeterol plus fluticasone propionate (SFC) in patients with severe or very severe COPD is well documented. However, there are only limited data about the influence of GOLD severity staging on the effectiveness of SFC, particularly in patients with milder disease... CONCLUSION: In the TORCH study, SFC reduced moderate-to-severe exacerbations and improved health status and FEV1 across GOLD stages. Treatment with SFC may be associated with reduced mortality compared with placebo in patients with GOLD stage II disease. The effects were similar to those reported for the study as a whole. Thus, SFC is an effective treatment option for patients with GOLD stage II COPD. TRIAL REGISTRATION: Clinicaltrial.gov registration NCT00268216; Study number: SCO30003.
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.
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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