WARNING: RISK OF ASTHMA-RELATED DEATH
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 and Precautions].
ADVAIR DISKUS SUMMARY
ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate.
Maintenance Treatment of Asthma
ADVAIR DISKUS is indicated for the long-term, twice-daily, maintenance treatment of asthma in patients aged 4 years and older.
Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, may increase the risk of asthma-related death [see Warnings and Precautions]. 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.
Important Limitations of Use:
Maintenance Treatment of Chronic Obstructive Pulmonary Disease
- ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.
- ADVAIR DISKUS is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2-agonists.
ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. ADVAIR DISKUS 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength ADVAIR DISKUS 500/50 over ADVAIR DISKUS 250/50 has not been demonstrated.
Important Limitations of Use: ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.
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. 
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...
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
Onset of Action of Advair Hydrofluoroalkane (HFA) 115/21 in Comparison to Symbicort Pressurised Metered-Dose Inhalers (pMDI) 160/4.5 Measured by Impulse Oscillometry (IOS) [Recruiting]
The objectives of this study are to measure Impulse Oscillometry (IOS) in patients with
asthma extensively at baseline in patients with mild-to-moderate asthma, treated with
as-needed short acting beta agonist only, to measure respiratory resistance and small airway
dysfunction accurately and precisely at baseline, from which to measure onset of action of
Advair MDI in comparison with that of Symbicort MDI. Initial screening will assess IOS
resistance and small airway dysfunction and its response to short acting beta agonist
(SABA). Patients will be selected from among those who manifest a 40% improvement in small
airway function assessed by IOS low frequency reactance after SABA compared to baseline.
After screening, patients will be randomized to receive either Advair or Symbicort; and will
be assessed at randomization before and at several intervals after initial dosing, up to 4
hours. Patients will return again 4 weeks after randomization for extended IOS (and
spirometry) testing as done at randomization.
MGR001 / Advair Diskus Local Equivalence Study in Asthma [Active, not recruiting]
The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when
administered by inhalation in adult asthma patients
The Effect on Depressive Symptoms in ECF Residents With COPD [Completed]
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.
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.
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
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|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|
|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
|Overall rating:|| || |
|Effectiveness:|| || Marginally Effective|
|Side effects:|| || Moderate Side Effects|
|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|
|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
|Overall rating:|| || |
|Effectiveness:|| || Marginally Effective|
|Side effects:|| || Extremely Severe Side Effects|
|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|
|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.|
Page last updated: 2013-02-10