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).
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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.
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ADVAIR HFA NEWS HIGHLIGHTS
Published Studies Related to Advair HFA (Fluticasone / Salmeterol)
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.
Early bronchodilatory effects of budesonide/formoterol pMDI compared with fluticasone/salmeterol DPI and albuterol pMDI: 2 randomized controlled trials in adults with persistent asthma previously treated with inhaled corticosteroids. [2008.05] Two identically designed, randomized, multicenter, single-dose, crossover studies were conducted in patients aged > or = 18 years with mild to moderate asthma previously treated with inhaled corticosteroids. After 2 weeks on twice-daily budesonide pressurized metered-dose inhaler (pMDI) 160 microg, patients received a randomized sequence of budesonide/formoterol pMDI 80/4.5 microg x 2 inhalations (160/9 microg), fluticasone/salmeterol [generic for Advair HFA] dry powder inhaler (DPI) 250/50 microg x 1 inhalation, albuterol pMDI 90 microg x 2 inhalations (180 microg), and placebo pMDI (3-to 14-day washout periods)...
Lower inhaled steroid requirement with a fluticasone/salmeterol combination in family practice patients with asthma or COPD. [2007.04] BACKGROUND: Previous studies on inhaled steroid and long-acting beta2-agonist combination products may not be representative for the asthma and chronic obstructive pulmonary disease (COPD) patients in family practice. OBJECTIVES: To compare in a group of doctor-diagnosed patients with asthma or COPD, the effects of a lower dose of fluticasone in a combination product with salmeterol with conventional treatment (i.e. a higher dose of fluticasone), both supplemented with as-needed use of a short-acting bronchodilator... CONCLUSIONS: In family practice patients diagnosed with asthma, several treatment goals were better achieved with a lower dose of fluticasone and salmeterol in a combination product than with a higher dose of fluticasone. We found no differences between the two approaches for patients with COPD.
Lower inhaled steroid requirement with a fluticasone/salmeterol combination in family practice patients with asthma or COPD. [2007.04] BACKGROUND: Previous studies on inhaled steroid and long-acting beta2-agonist combination products may not be representative for the asthma and chronic obstructive pulmonary disease (COPD) patients in family practice. OBJECTIVES: To compare in a group of doctor-diagnosed patients with asthma or COPD, the effects of a lower dose of fluticasone in a combination product with salmeterol with conventional treatment (i.e. a higher dose of fluticasone), both supplemented with as-needed use of a short-acting bronchodilator... CONCLUSIONS: In family practice patients diagnosed with asthma, several treatment goals were better achieved with a lower dose of fluticasone and salmeterol in a combination product than with a higher dose of fluticasone. We found no differences between the two approaches for patients with COPD.
Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? Study protocol for a randomized controlled trial [NCT00120978]. [2006.02.06] BACKGROUND: Systemic inflammation is associated with various complications in chronic obstructive pulmonary disease including weight loss, cachexia, osteoporosis, cancer and cardiovascular diseases. Inhaled corticosteroids attenuate airway inflammation, reduce exacerbations, and improve mortality in chronic obstructive pulmonary disease... DISCUSSION: If inhaled corticosteroids by themselves or in combination with a long-acting beta2-adrenoceptor agonist could repress systemic inflammation, they might greatly improve clinical prognosis by reducing various complications in chronic obstructive pulmonary disease.
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
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 (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.
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ADVAIR HFA PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Advair HFA has an overall score of 8.33. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Advair HFA review by 63 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | | Treatment Info |
| Condition / reason: | | Constant coughing due to mucous |
| Dosage & duration: | | 2 puffs per day--one in AM--one in PM (dosage frequency: 2 x per day) for the period of Have only been using it for about 1 mo. |
| Other conditions: | | High blood pressure, cholesterol |
| Other drugs taken: | | Lipitor, verapamil, over the counter allergy med | | | Reported Results |
| Benefits: | | Mucous very diminished, therefore, coughing has almost disappeared. Not sure whether my condition is a form of asthma, COPD, or what, but this medication has so far certainly made it much less bothersome. |
| Side effects: | | No noticeable side effects so far. |
| Comments: | | I use one puff first thing in the morning when I take my other medications, and one puff at bedtime. After using, you are instructed to rinse your mouth well. |
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| | 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. |
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| | 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. |
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Page last updated: 2008-06-22
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