Proair HFA (Albuterol Sulfate HFA Inhalation) - Summary

PROAIR HFA SUMMARY

PROAIR^® HFA (ALBUTEROL SULFATE) INHALATION AEROSOL For Oral Inhalation Only

The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate is a relatively selective beta₂-adrenergic agonist (see CLINICAL PHARMACOLOGY).

PROAIR HFA Inhalation Aerosol is indicated in adults and children 12 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

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NEWS HIGHLIGHTS

Published Studies Related to Proair HFA (Albuterol HFA)

Safety of daily albuterol in infants with a history of bronchospasm: a multi-center placebo controlled trial. [2009.07.16]
INTRODUCTION: Inhaled short-acting bronchodilators are recommended for the quick relief of bronchospasm symptoms in children including those less than five years of age. However, limited safety data is available in this young population... CONCLUSION: This study provides additional albuterol HFA safety information for the treatment of children aged birth </=24 months with a history of bronchospasm.

A cumulative dose study of levalbuterol and racemic albuterol administered by hydrofluoroalkane-134a metered-dose inhaler in asthmatic subjects. [2008.09]
BACKGROUND: The short-acting beta(2)-agonists levalbuterol and racemic albuterol are available for administration through a hydrofluoroalkane-134a (HFA) metered-dose inhaler (MDI). OBJECTIVE: This study compared the short-term safety and efficacy of cumulative doses of levalbuterol HFA MDI and racemic albuterol HFA MDI in asthmatic subjects... CONCLUSION: In this study single-day cumulative dosing of asthmatic subjects with levalbuterol HFA MDI or racemic albuterol HFA MDI resulted in similar improvements in FEV(1) and tolerability. Plasma (R)-albuterol levels and mean heart rate were less with levalbuterol HFA MDI.

Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma. [2007.12]
BACKGROUND: Previous studies have raised concerns regarding the safety of regular use of beta2-agonists for treating asthma. Few studies have explored the safety of at least 1 year of use of racemic albuterol, and none have examined long-term dosing of levalbuterol. OBJECTIVE: To examine the long-term safety of levalbuterol hydrofluoroalkane (HFA) vs racemic albuterol HFA administered via metered-dose inhaler (MDI) in patients with stable asthma... CONCLUSION: In this trial, up to 52 weeks of regular use of levalbuterol HFA MDI or racemic albuterol HFA MDI was well tolerated, and no deterioration of lung function was detected during the study period.

An evaluation of levalbuterol HFA in the prevention of exercise-induced bronchospasm. [2007.11]
BACKGROUND: Exercise-induced bronchospasm (EIB) affects up to 90% of all patients with asthma. Objective. This study evaluated the ability of levalbuterol hydrofluoroalkane (HFA) 90 mug (two actuations of 45 microg) administered via metered dose inhaler (MDI) to protect against EIB in mild-to-moderate asthmatics... CONCLUSION: Levalbuterol HFA MDI (90 microg) administered 30 minutes before exercise was significantly more effective than placebo in protecting against EIB after a single exercise challenge and was well tolerated. CLINICAL IMPLICATIONS: Levalbuterol HFA MDI when administered before exercise was effective in protecting adults with asthma from EIB.

Comparison of the bronchodilating effects of formoterol and albuterol delivered by hydrofluoroalkane pressurized metered-dose inhaler. [2005]
OBJECTIVE: To compare the onset of bronchodilation with a new formoterol hydrofluoroalkane (HFA) pressurized metered-dose inhaler (pMDI) with albuterol (salbutamol) HFA pMDI... CONCLUSION: In stable, mild, or moderate asthma, formoterol 9microg and albuterol 200microg, both by HFA pMDI, provided equally rapid and effective bronchodilation.

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Clinical Trials Related to Proair HFA (Albuterol HFA)

Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients [Recruiting]
Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease

Childhood Asthma Research and Education (CARE) Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA) [Recruiting]
Asthma is a common, serious illness among children in the United States. It can be effectively controlled through the use of preventative medications and "rescue" medications, which are used to control symptoms. This study will evaluate the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving various combinations of medications for daily and rescue use.

Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room. [Recruiting]
To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve FEV1 and decrease the need for hospitalization.

The Safety and Effectiveness of MK0476 in Patients With Chronic Asthma [Recruiting]
This study will test the safety and effectiveness of a range of doses of MK0476 compared to placebo on improved lung function in patients with chronic asthma.

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PATIENT REVIEWS / RATINGS / COMMENTS

Proair HFA review by 59 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Asthma flares
Dosage & duration:		2 puffs every four hours (dosage frequency: as needed) for the period of 4 times daily for 5 days
Other conditions:		Depression, Adult ADD, low thyroid
Other drugs taken:		levothyroxin, fluoxetine, bupropion, trazodone
		Reported Results
Benefits:		I was able to breathe more freely after I took this medication and my peak flow meter readings were significantly higher.
Side effects:		I did not notice any side effects. However, unless I positioned the inhaler very carefully, some of the medication ended up in my mouth rather than being inhaled.
Comments:		I was also using a Q-Var inhaler twice a day during the flare (I normally use it once a day.) My treatment regimen when I have a flare is Q-var at 2 puffs twice a day, and the ProAir inhaler 2 puffs every four hours.