DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Advair Diskus (Fluticasone Propionate / Salmeterol Xinafoate Inhalation) - Summary

 
 



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).

 

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.


See all Advair Diskus indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Advair Diskus (Fluticasone / Salmeterol Xinafoate)

Long-term treatment with fluticasone propionate/salmeterol via Diskus improves asthma control versus fluticasone propionate alone. [2011.03]
This 52-week study was designed to assess the safety and efficacy of fluticasone propionate/salmeterol combination (FSC) 250/50 micrograms versus fluticasone propionate (FP) 250 micrograms in subjects with persistent asthma symptomatic on open-label FP 100 micrograms.In addition, FSC 250/50 micrograms-treated subjects experienced fewer severe asthma exacerbations than subjects treated with FP 250 micrograms.

Body mass index and response to asthma therapy: fluticasone propionate/salmeterol versus montelukast. [2010]
We studied the relationship between body mass index (BMI) on responses to asthma therapy using a retrospective analysis of four previously reported clinical trials. Fluticasone propionate (FP)/salmeterol via Diskus 100/50 microg twice daily and montelukast (MON) 10 mg daily were compared.Treatment responses to FP/salmeterol were consistently greater compared to MON and persisted at higher BMI.

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...

more studies >>

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

The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With Chronic Obstructive Pulmonary Disease (COPD) [Not yet recruiting]
The purpose of this study is to assess the effect of treatment with Advair Diskus on depression using the Cornell depression scale in COPD patients in the nursing home.

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 (AdvairĀ®) or oral prednisone for 10 days. The hypothesis is that AdvairĀ® 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 AdvairĀ® 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 AdvairĀ® could be a good alternative to prednisone for patients with steroid-induced hyperglycemia.

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.

more trials >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 8 ratings/reviews, Advair Diskus has an overall score of 7.12. The effectiveness score is 7.25 and the side effect score is 7.75. 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 44 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Asthma
Dosage & duration:   250/50 (dosage frequency: twice a day) for the period of 7 years and continuing
Other conditions:   Seasonal Allergies
Other drugs taken:   Allegra as needed
  
Reported Results
Benefits:   I am able to breath more easily. Taking the medication keeps my airways open and keeps me alive.
Side effects:   More easy bruising than when not on the medication. This isn't a big deal.
Comments:   The medication comes in a plastic disk, which contains 60 measured doses in a blister pack. This lasts 30 days. Each morning and evening the plastic disk is opened and the next dose is opened. One must exhale and then place the disc with the mouth covering the opening and evenly and steadily inhale. Close the disc. I hold me breathe for about 30 seconds and then exhale. Then you need to rinse your mouth so that the medication does not cause oral thrush.

 

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.

 

Advair Diskus review by 80 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   COPD
Dosage & duration:   At first 500/50, then 250/50 (dosage frequency: twice a day.) for the period of Several years.
Other conditions:   none
Other drugs taken:   Duoneb, Zyrtec
  
Reported Results
Benefits:   At first it helped.
Side effects:   I did not realize at first that they were side effects. I thought that my chronic bronchitis had gotten much worse. Then I began to develop bouts of extreme fatigue, anxiety and occasional panic attacks that had nothing to do with COPD. Then I started to have choking fits. They were becoming so serious that I feared choking to death. I suspected Advair, so I tried not taking it and then taking it again. The cause was identified and I stopped taking Advair. The choking fits ceased. The fatigue, anxiety, and panic attacks were found to be a malfunciton of my adrenal gland (confimed by lab tests). The chronic bronchitis improved dramatically.
Comments:   I was diagnosed with COPD about 12 years ago. I started taking Advair about eight years ago. During the course of treatment I tried Spiriva, but had to stop because it was very drying. At one time I was taking Singulair, but that didn't seem to do much of anything. So I quit that. Throughout the entire period I have used Duoneb and Zyrtec. I think I was originally put on 250/50 Advair. That was increased, some years back, to 500/50, and about two years ago reduced back to 250/50. At all times I used the Advair twice a day. My pulmonologist (also primary care physician) was not much help when I developed side effects, nor did he suggest a substitute treatment when I had to stop using Advair. I went to another doctor who treated me for adrenal fatigue and had me take natural anti-inflammatories and mucolytics to replace the Advair. I still take Duoneb and Zyrtec. I stopped taking the Advair one year ago. I am just now recovering from the adrenal problem. My COPD has not worsened.

See all Advair Diskus reviews / ratings >>

Page last updated: 2013-02-10

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014