WARNING
Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. 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 an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo) (see WARNINGS).
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ADVAIR DISKUS SUMMARY
ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate.
Asthma: ADVAIR DISKUS is indicated for the long-term, twice-daily, maintenance treatment of asthma in patients 4 years of age and older.
ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.
Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis: ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis.
ADVAIR DISKUS 250/50 mcg twice daily is the only approved dosage for the treatment of COPD associated with chronic bronchitis. Higher doses, including ADVAIR DISKUS 500/50, are not recommended (see DOSAGE AND ADMINISTRATION: Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis).
The benefit of treating patients with COPD associated with chronic bronchitis with ADVAIR DISKUS 250/50 for periods longer than 6 months has not been evaluated. Patients who are treated with ADVAIR DISKUS 250/50 for COPD associated with chronic bronchitis for periods longer than 6 months should be reevaluated periodically to assess the continuing benefits and potential risks of treatment.
ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.
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ADVAIR DISKUS NEWS HIGHLIGHTS Media Articles Related to Advair Diskus (Fluticasone / Salmeterol Xinafoate)
fluticasone and salmeterol oral inhaler, Advair Diskus
Source: MedicineNet fluticasone propionate nasal inhaler-spray Specialty [2006.07.27]
Title: fluticasone and salmeterol oral inhaler, Advair Diskus
Category: Medications
Created: 1/22/2002 7:43:00 PM
Last Editorial Review: 7/27/2006
Published Studies Related to Advair Diskus (Fluticasone / Salmeterol Xinafoate)
Deterioration in asthma control when subjects receiving fluticasone propionate/salmeterol 100/50 mcg Diskus are "stepped-down". [2008.10]
In this study, 647 subjects stable on fluticasone propionate/salmeterol Diskus 100/50 mcg BID (FSC) were randomized to continue FSC 100/50 mcg BID or "step down" to either fluticasone propionate (FP) 100 mcg BID, salmeterol (SAL) 50 mcg BID, or montelukast (MON) 10 mg once daily for 16 weeks.
Comparison of the effects of salmeterol/fluticasone propionate with fluticasone propionate on airway physiology in adults with mild persistent asthma. [2007.07.14]
BACKGROUND: This study compared the effect of inhaled fluticasone propionate (FP) with the combination of salmeterol/fluticasone propionate (SFC) on lung function parameters in patients with mild asthma... CONCLUSION: SFC is superior to FP in reducing airway resistance in mild asthmatics with near normal FEV1 values. This study provides evidence that changes in pulmonary function in patients with mild asthma are detected more sensitively by plethysmography compared to spirometry TRIAL REGISTRATION NUMBER: NCT00370591.
Initiation of maintenance therapy with salmeterol/fluticasone propionate combination therapy in moderate asthma: a comparison with fluticasone propionate. [2007.07]
The objective of this study was to investigate initial maintenance treatment with salmeterol/fluticasone propionate (Seretide) 50/250 mu g twice daily (SFC) compared with fluticasone propionate (Flixotide) 250 mu g twice daily (FP) (both via Diskus inhaler, GlaxoSmithKline, Greenford, UK) in patients with moderate persistent asthma currently only treated with inhaled short-acting beta(2)-agonists...
The safety of twice-daily treatment with fluticasone propionate and salmeterol in pediatric patients with persistent asthma. [2005.07]
BACKGROUND: For children older than 5 years with asthma who remain symptomatic despite inhaled corticosteroid (ICS) therapy, the preferred treatment is to add an inhaled long-acting beta2-agonist vs increasing the ICS dose. OBJECTIVE: To compare the safety of twice-daily treatment with inhaled fluticasone propionate plus the inhaled long-acting beta2-agonist salmeterol with that of fluticasone propionate used alone in children aged 4 to 11 years with persistent asthma... CONCLUSIONS: In pediatric patients with persistent asthma, fluticasone propionate-salmeterol twice daily was well tolerated, with a safety profile similar to that of fluticasone propionate used alone.
Efficacy and safety of salmeterol/fluticasone propionate delivered via a hydrofluoroalkane metered dose inhaler in Chinese patients with moderate asthma poorly controlled with inhaled corticosteroids. [2005.07]
A randomised, open-label, multicentre study compared the efficacy and tolerability of salmeterol 25 microg/fluticasone propionate 125 microg (two puffs, twice daily) delivered via a hydrofluoroalkane metered-dose inhaler (HFA-MDI) and salmeterol 50microg/fluticasone propionate 250 microg (one puff, twice daily) delivered via a Diskus inhaler in Chinese patients with moderate asthma uncontrolled with inhaled corticosteroids (ICSs)...
Clinical Trials Related to Advair Diskus (Fluticasone / Salmeterol Xinafoate)
A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS [Completed]
Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA
Atlantis Symbicort [Completed]
The purpose of this study is to determine whether Symbicort compared with Advair, will be
more effective in controlling asthma in adults and adolescents.
SERETIDE Plus Tiotropium Versus Individual Components [Completed]
This study was designed to evaluate the effects on lung function of a combination of
SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the
individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice
daily alone) in subjects with COPD. The study will utilise a three-way cross-over design
with a 2-week wash-out period between each 2-week consecutive treatment period.
Symbicort Onset of Action 1 [Completed]
The purpose of this study is to compare the early onset of effect of Symbicort compared to
Advair Diskus and Ventolin in adults with asthma
Effects of Advair� in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation [Not yet recruiting]
Short course of steroids in COPD exacerbation improves FEV1 and decreases the relapse rate.
However, some concerns remain about using systemic steroids for all patients with acute
exacerbation. Their short-term advantages may be outweighed by the occurrence of adverse side
effects such as hyperglycemia, which is difficult to manage on an outpatient basis. In this
context, the possibility of treating patients with COPD exacerbation with inhaled steroids
having less systemic adverse effects is interesting. The objectives are to compare relapse
rate, lung function, the severity of dyspnea and, systemic and sputum inflammatory markers in
outpatients with acute COPD exacerbations treated with fluticasone/salmeterol (Advair®) or
oral prednisone for 10 days. The hypothesis is that Advair® is as effective as prednisone in
treatment of outpatients with COPD exacerbation. The primary endpoint is to determine if the
relapse rate at one month is equivalent for both treatments. The secondary endpoints are to
compare lung function and dyspnea score and, systemic and sputum inflammatory markers
modulation after 10 days of both treatments. We will recruit 30 outpatients in each group
from our COPD clinic. Patients will receive prednisone (40mg/day) with placebo diskus or
Advair® 50/500ug 2 inhalations bid (twice the regular dose) with placebo pills for 10 days.
All patients will receive antibiotics and short-acting bronchodilators as needed. We expect
to demonstrate that the improvement of lung function, dyspnea, inflammatory markers and
relapse rate are equivalent in both treatments suggesting that Advair® could be a good
alternative to prednisone for patients with steroid-induced hyperglycemia.
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ADVAIR DISKUS PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 6 ratings/reviews, Advair Diskus has an overall score of 7.67. The effectiveness score is 7.33 and the side effect score is 8.33. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Advair Diskus review by 21 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | asthma |
| Dosage & duration: | | 100/50 (dosage frequency: twice a day) for the period of 5 years |
| Other conditions: | | none |
| Other drugs taken: | | albuterol when needed | | |
Reported Results |
| Benefits: | | Ever since I was littel I would use albuterol at night about once a week when needed because my breathing was so bad. Ever since I've been on advair, I no longer need albuterol. My breathing is stronger according to doctors and I enjoy exercise without having breathing complications. |
| Side effects: | | There are no negative side effects that I know of. |
| Comments: | | In the morning I crush a pill and breath it in through the mouth peice. This is done at night as well. I continue to do this everyday day for about 5 years now. |
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| | Advair Diskus review by 35 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | asthma |
| Dosage & duration: | | 250/50 (dosage frequency: 2 times per day, 12 hours apart.) for the period of 4 months |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Advair helped with my asthma initially, which was agrivated by an upper resperitory virus. |
| Side effects: | | Heart palpitations and coughing. These side affects have been decreasing since I discontinued the drug. Advair seems to be fine for a short time, only to aggravate things later on. |
| Comments: | | I was treated for asthma which kicked up during the winter cold season, and my doctor put me on advair and prednisone (short dose). I continued on the Advair for four months and as time went on the side affects became more and more pronounced. My doctor currently has me off of all steroids and the Advair and is watching me for any complications. blood tests for thyroid and glucose came back within normal levels. |
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| | Advair Diskus review by 35 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | asthma |
| Dosage & duration: | | 250/50 (dosage frequency: twice per day) for the period of four months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Slight initial improvement of viral aggravated asthma. |
| Side effects: | | heart palpitations and coughing began in the second month. These side affects continued to get worse over time. |
| Comments: | | I have already completed a survey about the advair and unfortunately did not get the download due to some kind of glitch. I am resubmitting this information again. |
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Page last updated: 2008-11-03
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