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Advair HFA (Fluticasone Propionate / Salmeterol Xinafoate) - Summary

 
 



WARNING

Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR HFA, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR HFA 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 HFA SUMMARY

ADVAIR HFA 45/21 Inhalation Aerosol, ADVAIR HFA 115/21 Inhalation Aerosol, and ADVAIR HFA 230/21 Inhalation Aerosol are combinations of fluticasone propionate and salmeterol xinafoate.

ADVAIR HFA is indicated for the long-term, twice-daily maintenance treatment of asthma in patients 12 years of age and older.

Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR HFA, may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, physicians shouldonly prescribe ADVAIR HFA 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. ADVAIR HFA 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 HFA is NOT indicated for the relief of acute bronchospasm.


See all Advair HFA indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Advair HFA (Fluticasone / Salmeterol)

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.

Comparison of heat-sensitive moxibustion versus fluticasone/salmeterol (seretide) combination in the treatment of chronic persistent asthma: design of a multicenter randomized controlled trial. [2010.12.15]
BACKGROUND: Asthma is a major health problem and has significant mortality around the world. Although the symptoms can be controlled by drug treatment in most patients, effective low-risk, non-drug strategies could constitute a significant advance in asthma management.Moreover, the result may propose a new type moxibustion to control asthma.

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.

Effects of fluticasone propionate and salmeterol hydrofluoroalkane inhalation aerosol on asthma-related quality of life. [2009.04]
BACKGROUND: Current asthma guidelines emphasize domains of impairment and risk for assessing severity and control, noting the need to consider separately the effects of asthma on asthma quality of life and functional capacity. Proper treatment to control asthma should result in improvements in patient well-being and functional status. OBJECTIVE: To assess asthma-related quality of life after treatment with combination fluticasone propionate and salmeterol delivered via hydrofluoroalkane 134a metered-dose inhaler compared with the individual components alone... CONCLUSIONS: Treatment with combination fluticasone propionate and salmeterol delivered via hydrofluoroalkane metered-dose inhaler resulted in significantly greater improvements in asthma-related quality of life compared with individual components and placebo administered via traditional chlorofluorocarbon metered-dose inhaler.

The effects of fluticasone with or without salmeterol on systemic biomarkers of inflammation in chronic obstructive pulmonary disease. [2008.06.01]
RATIONALE: Small studies have suggested that inhaled corticosteroids can suppress systemic inflammation in chronic obstructive pulmonary disease (COPD). OBJECTIVES: To determine the effect of inhaled corticosteroids with or without long-acting beta(2)-adrenergic agonist on systemic biomarkers of inflammation... CONCLUSIONS: ICS in conjunction with long-acting beta(2)-adrenergic agonist do not reduce CRP or IL-6 levels in serum of patients with COPD over 4 weeks. They do, however, significantly reduce serum SP-D levels. These data suggest that these drugs reduce lung-specific but not generalized biomarkers of systemic inflammation in COPD.

more studies >>

Clinical Trials Related to Advair HFA (Fluticasone / Salmeterol)

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.

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.

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.

more trials >>

Reports of Suspected Advair HFA (Fluticasone / Salmeterol) Side Effects

Tremor (4)Dizziness (3)Gastric Disorder (3)Memory Impairment (3)Agitation (2)Contusion (2)Pruritus (2)Drug Ineffective (2)Muscle Contractions Involuntary (2)Disorientation (2)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 6 ratings/reviews, Advair HFA has an overall score of 7.83. The effectiveness score is 8.33 and the side effect score is 8.67. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Advair HFA review by 47 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   asthma
Dosage & duration:   250/50 (dosage frequency: 2 times a day) for the period of still taking
Other conditions:   none
Other drugs taken:   Theodur
  
Reported Results
Benefits:   Once I started using the inhaler it greatly reduced night time waking with asthma symptoms. Early morning breathing became easier instead of tight breathing. My use of a rescue inhaler specifically, Proventil, was cut down from several times a night to usually 0. I only use my rescue inhaler occassionally now instead of routinely. My life has changed with Advair, I highly recommend it!
Side effects:   When I first started it, I noticed a little bit of nervousness, this only lasted a few days, and with continued use, I am no longer having any side effects. I have never experienced any of the lung infections the package insert speaks of, nor have I ever had sudden asthma symptoms after using the Advair Inhaler.
Comments:   One inhalation of the Advair Inhaler in the morning and one again at bedtime.

 

Advair HFA review by 29 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   asthma
Dosage & duration:   1 puff twice a day (dosage frequency: everyday) for the period of 3 years
Other conditions:   allergies
Other drugs taken:   allegra-d
  
Reported Results
Benefits:   improved breathing, less frequent asthma attacks and the ability to run either outside or inside, depending on the season
Side effects:   no side effects really. despite it all, i still had some difficulty depending on the season. when cedar is really high, i still suffered asthma related problems even though i was taking the drug regularly.
Comments:   advair is an inhaled power that you take twice a day. it's composed of two "active ingredient" - a long acting bronchio dilator and a steroid - both aid in combating asthma.

 

Advair HFA review by 38 year old male patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   asthma
Dosage & duration:   500/50 (dosage frequency: twice daily) for the period of 9 years
Other conditions:   allergies
Other drugs taken:   zyrtec
  
Reported Results
Benefits:   reduction of asthma symptoms and severity, less shortness of breath and light headedness
Side effects:   Unfortunately with prolonged use (after about 8 years)my immune defense system in the lungs was virtually non existent. My doctors found a plethora of 15 different bacteria, fungi and viruses in the lung, and associated the condition with either AIDS or cancer. Things that are usually prevented by the immune system,opportunistic infections were abundant and had spread, in spite of antibiotic and antifungal use, to a sytemic infection. Nocardia siriacogeorgensis, MRSA, MAC, aspergillus, pseudomonas among others were all found. the Nocardia in particualr had already caused a mild form of encephalitis.
Comments:   Twice daily, one puff, every day.

See all Advair HFA reviews / ratings >>

Page last updated: 2011-12-09

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