• KOL
    • Racemic Albuterol
    • Evaluation Of Levalbuterol...
    • Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: a double-blind, randomized, placebo- and active-controlled trial: Influence Statistics

      Expert Impact

      Concepts for whichthey havehas direct influence:Racemic albuterol,Metered dose,Dose inhaler,Levalbuterol racemic,Patients asthma,Albuterol asthma,90 microg,Safety levalbuterol.

      Key People For Racemic Albuterol

      Top KOLs in the world
      #1
      Sidney S DeGraw
      racemic albuterol pediatric patients placebo treatment
      #2
      George W Bensch
      pulmicort turbuhaler mometasone furoate racemic albuterol
      #3
      David S Reasner
      racemic albuterol pediatric patients placebo treatment
      #4
      Harold S Nelson
      allergic rhinitis sublingual immunotherapy inhaled corticosteroids
      #5
      Warren W Pleskow
      racemic albuterol fluticasone propionate seasonal allergic rhinitis
      #6
      Thomas E Rollins
      racemic albuterol improved bronchodilation patients asthma

      Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: a double-blind, randomized, placebo- and active-controlled trial

      Abstract

      OBJECTIVE: To evaluate the efficacy and safety of levalbuterol metered dose inhaler (MDI) in children aged 4-11 years (n = 173).

      RESEARCH DESIGN AND METHODS: Multicenter, randomized, double-blind 28-day study of QID levalbuterol 90 microg, racemic albuterol 180 mug, and placebo (2:1:1 ratio). Serial spirometry was performed on Days 0, 14, and 28. The primary endpoint was the double-blind average peak percent (%) change in FEV(1) from visit pre-dose; the primary comparison was with placebo. Secondary endpoints included the area under the FEV(1) percent change from pre-dose curve and peak % predicted FEV(1). Safety endpoints included adverse events, laboratory tests, rescue medication use, and electrocardiograms.

      RESULTS: Levalbuterol significantly improved the least square mean peak percent change in FEV(1) compared with placebo (levalbuterol 25.6% +/- 1.3% [p < 0.001]; racemic albuterol 21.8% +/- 1.8% [p = ns]; placebo 16.8% +/- 1.9%). Results for levalbuterol were similar for the other spirometry endpoints (p < 0.05 vs. placebo). No levalbuterol-treated patients had a peak percent change in FEV(1) < 10% (compared with 15.8% of racemic albuterol-treated patients and 30.3% of placebo-treated patients). The incidence of adverse events was 43.4% for levalbuterol, 56.4% for racemic albuterol, and 51.4% for placebo. The rate of discontinuation was 1.3% for levalbuterol, 2.6% for racemic albuterol, and 8.6% for placebo. The rate of asthma attacks (10.5%, 12.8%, 14.3%, respectively) was similar among treatments. Levalbuterol and racemic albuterol both reduced rescue medication use (p < 0.01 vs. placebo) and produced changes in ventricular heart rate and QT(c-F) that were similar to placebo.

      CONCLUSIONS: In this study, levalbuterol administered via MDI significantly improved airway function in comparison with placebo in asthmatic children aged 4-11 years with a safety profile that was similar to placebo.

      Sign-in to see all concepts, it's free!

       

    Download on the App StoreGet it on Google Play

    Copyright © 2023 KOL - Key Opinion Leaders, LLC.

    KOL does not provide medical advice, diagnosis or treatment.