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.
Published Studies Related to Proair HFA (Albuterol HFA)
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.
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
Efficacy and Safety Study of Procaterol Hydrochloride to Treat Patients With Cough Variant Asthma (CVA) [Not yet recruiting]
The purpose of this study is to investigate the efficacy and safety of procaterol
hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma
Efficacy Study of Synbitide HFA MDI in Asthma Patients [Recruiting]
The objective of the study is to evaluate the dose response of Synbitide HFA MDI, which is a
combination drug product of budesonide and procaterol hydrochloride, in asthma patients.
Patients with mild to moderate asthma will be recruited. There will be two study medication
administered in this study. The investigational medication is Synbitide
(Budesonide/Procaterol hydrochloride, 180 mcg/10 mcg per inhalation) and the active
comparative medication is Ventolin (Salbutamol sulfate 100 mcg per inhalation). The study
medication will be administered by oral inhalation with the supervision of the investigator
or a qualified staff.
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.
Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma [Recruiting]
The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax®
versus placebo in subjects with persistent asthma.
Reports of Suspected Proair HFA (Albuterol HFA) Side Effects
Drug Ineffective (173),
Drug Effect Decreased (26),
Throat Irritation (17),
Chest Discomfort (13), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
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|
|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|
|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|
|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|
|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. |
Page last updated: 2010-10-05