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Proair HFA (Albuterol Sulfate) - Summary



The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol.


PROAIR HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm

PROAIR HFA Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

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Published Studies Related to Proair HFA (Albuterol)

Repeat dosing of albuterol via metered-dose inhaler in infants with acute obstructive airway disease: a randomized controlled safety trial. [2010.03]
BACKGROUND: Airway obstruction and bronchial hyperactivity often times lead to emergency department visits in infants. Inhaled short-acting beta2-agonist bronchodilators have traditionally been dispensed to young children via nebulizers in the emergency department. Delivery of bronchodilators via metered-dose inhalers (MDIs) in conjunction with holding chambers (spacers) has been shown to be effective. STUDY OBJECTIVE:: Safety and efficacy evaluations of albuterol sulfate hydrofluoroalkane (HFA) inhalation aerosol in children younger than 2 years with acute wheezing caused by obstructive airway disease... CONCLUSIONS: Cumulative dosing with albuterol HFA 180 microg or 360 microg via MDI-spacer and face mask in children younger than 2 years did not result in any significant safety issues and improved MTASS by at least 48%.

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.

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Clinical Trials Related to Proair HFA (Albuterol)

Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients [Completed]
This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with persistent asthma. The primary purpose of this study is to compare the efficacy and safety of Albuterol Spiromax with that of ProAir HFA in pediatric asthma patients at 2 delivered dose levels equivalent to 90 mcg and 180 mcg of albuterol base.

Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax� and ProAir� Hydrofluoroalkane (HFA) in Pediatric Patients With Asthma [Completed]

A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma [Completed]
This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.

Effect of Oral Procaterol on Postinfectious Persistent Cough [Not yet recruiting]
The purpose of this study is to investigate the effectiveness of oral procaterol in treatment of non-asthmatic patients who suffer from persistent cough following upper respiratory tract infection (URTI).

Comparative Study on the Efficacy and Safety of Procaterol Versus Salbutamol Given Via Metered Dose Inhaler With Spacer in the Management of Acute Asthma Attack in the Emergency Room [Completed]

more trials >>

Reports of Suspected Proair HFA (Albuterol) Side Effects

Drug Ineffective (173)Dyspnoea (58)Drug Effect Decreased (26)Asthma (24)Cough (21)Throat Irritation (17)Headache (16)Choking (16)Dysgeusia (15)Chest Discomfort (13)more >>


Based on a total of 2 ratings/reviews, Proair HFA has an overall score of 9. The effectiveness score is 9 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.

Proair HFA review by 61 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   asthma
Dosage & duration:   as needed (dosage frequency: seasonally with allergies) for the period of still taking it as needed
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   The albuterol relieved the constriction, irritation and wheezing I experienced. It worked both as a preventive and as a curative measure for those symptoms. I have occasionally experienced exercise induced asthma (actually after I stop exercising) and taking the albuterol in advance helped alleviate that.
Side effects:   I have experienced no side effects.
Comments:   I use the albuterol as needed because of allergies (seasonal, dust, exercise) and can go for long times without using it.


Proair HFA review by 59 year old female patient

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.

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Page last updated: 2010-10-05

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