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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NEWS HIGHLIGHTS
Published Studies Related to Advair HFA (Fluticasone / Salmeterol)
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.
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 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.
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
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.
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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 care giver of 59 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | | Treatment Info |
| Condition / reason: | | Asthma/Allergies |
| Dosage & duration: | | 2 puffs/inhales daily (AM & PM) (dosage frequency: 2 puffs/inhales daily (am & pm)) for the period of 1.5 years -- still taking it |
| Other conditions: | | Gingevitis |
| Other drugs taken: | | None | | | Reported Results |
| Benefits: | | Overall, the benefits have been very good. A rescue inhaler hasn't been used in more than a year, nor has there been a severe asthma attack. During the period there may have been three incidences where it seemed like an attack was coming on (curing exertion and cold, damp weather) but simply a better environment and a couple of cups of coffee warded it off. There are times of wheezy, heavy-chestedness, but these are minimal in comparison to prior to taking Advair. |
| Side effects: | | Wallet shock. Patient seems to overall fall asleep easier, but tends to have some problems getting a deep sleep, but this may or may not be related to the Advair. Other than that, there do not seem to be any adverse side effects -- casually or medically -- after about 1-1/2 years of taking the medication. |
| Comments: | | The patient developed asthma four years ago. It was controlled on an 'attack' basis, generally with an OTC inhaler. When most OTC inhalers were taken off the market prior to reformulation, and a severe asthma attack, a prescription inhaler was prescribed, but it was being used more often than should, and did not alleviate the problems. After a thorough examination, the doctor prescribed Advair, as directed with two puffs/inhales daily, morning and evening (at least 8 hours apart). The patient is examined/tested every three months prior to refilling prescription to ensure there are no side-effects or adverse reactions. |
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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: 2009-10-20
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