In a double-blind, randomized, placebo-controlled 3-week study
evaluating ProAir RespiClick® in 184 pediatric patients (ages 4-11)
with asthma, ProAir RespiClick® had efficacy greater than placebo.1


The efficacy of ProAir RespiClick® was assessed in a 3-week, randomized, double-blind, placebo-controlled study. After a 2-week run-in period, treatment was administered for 3 weeks, with a follow-up after 3 weeks. Children ages 4 to 11 (n=184, with 92 in each arm) were randomly assigned to receive ProAir RespiClick® at a dose of 180 mcg or placebo inhaler, four times daily.

Day 1: Significantly greater FEV1 with ProAir RespiClick®1

Increases in baseline-adjusted FEV1 up to 6 hours (AUC0-6hr) were significantly greater for ProAir RespiClick® than for placebo at Day 1.


Day 22: Significantly greater FEV1 with ProAir RespiClick®1

Increases in baseline-adjusted FEV1 up to 6 hours (AUC0-6hr) were significantly greater for ProAir RespiClick® than for placebo at Day 22.


In a double-blind, randomized, placebo-controlled, single-dose crossover study evaluating ProAir RespiClick® and the leading rescue metered-dose inhaler in 71 adult and adolescent patients,12 years of age and older with persistent asthma, ProAir RespiClick® had efficacy greater than placebo.2


In two replicate 12-week, randomized, double-blind, placebo-controlled trials, ProAir RespiClick® (n=153) was compared with placebo (n=163) in asthmatic patients 12 to 76 years of age at a dose of 180 mcg albuterol 4 times daily.

Study 1: Significantly greater FEV1 with ProAir RespiClick®2

Increases in baseline-adjusted FEV1 up to 6 hours (AUC0-6hr) were significantly greater (P<0.0001) for ProAir RespiClick® than for placebo in Study 1.


Study 2: Significantly greater FEV1 with ProAir RespiClick®2

Increases in baseline-adjusted FEV1 up to 6 hours (AUC0-6hr) were significantly greater (P<0.0001) for ProAir RespiClick® than for placebo in Study 2.


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Indications

ProAir RespiClick® (albuterol sulfate) Inhalation Powder is indicated in patients 4 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.

Important Safety Information

  • ProAir RespiClick® (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose
  • ProAir RespiClick® can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir® RespiClick and institute alternative therapy if paradoxical bronchospasm occurs

Indications

ProAir RespiClick® (albuterol sulfate) Inhalation Powder is indicated in patients 4 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.

Important Safety Information

  • ProAir RespiClick® (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose

  • ProAir RespiClick® can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir RespiClick® and institute alternative therapy if paradoxical bronchospasm occurs

  • Need for more doses of ProAir RespiClick® than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment

  • ProAir RespiClick® alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids

  • ProAir RespiClick®, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued

  • ProAir RespiClick®, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), convulsive disorders, hyperthyroidism, and diabetes

  • Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. Do not exceed the recommended dose

  • Immediate hypersensitivity reactions may occur. Discontinue ProAir RespiClick® immediately

  • ProAir RespiClick® may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation

  • Potential drug interactions can occur with beta-blockers, diuretics, digoxin, or monoamine oxidase inhibitors, and tricyclic antidepressants

  • In controlled studies of ProAir RespiClick® in patients 12 years of age and older, adverse events that occurred at an incidence rate of at least 1% and greater than placebo included back pain (2% vs 1%), pain (2% vs <1%), gastroenteritis viral (1% vs <1%), sinus headache (1% vs <1%), and urinary tract infection (1% vs <1%)

  • In controlled studies of ProAir RespiClick® in patients 4 to 11 years of age, adverse events that occurred at an incidence rate of at least 2% and greater than placebo included nasopharyngitis (2% vs 1%), oropharyngeal pain (2% vs 1%), and vomiting (3% vs 1%)

Please see full Prescribing Information.

REFERENCES

1. Data on file (ProAir RespiClick DOF-ABS-AS-303). Horsham, PA: Teva Respiratory, LLC; 2016. 2. ProAir RespiClick Prescribing Information. Horsham, PA: Teva Respiratory, LLC; April 2016.