PROVENTIL HFA AND VENTOLIN HAVE SIMILAR SAFETY PROFILES DURING REGULAR USE

Objective: As a secondary objective to a long-term study evaluating th e bronchodilator effectiveness of Proventil HFA (albuterol), to assess the safety of Proventil HFA, Ventolin, and hydrofluoroalkane 134a (HF A-134a) placebo over 12 weeks of regular dosing. Design: Randomized, d ouble-blind, double-dummy parallel group, placebo-controlled, multicen ter trial of asthmatics requiring inhaled beta-adrenergic bronchodilat ors for symptom control. Interventions: Treatment with Proventil HFA, Ventolin, or HFA-134a placebo, qid, for 12 weeks. Measurements: Advers e events were reviewed at biweekly clinic visits. Between clinic visit s, patients recorded disturbance scores, and use of rescue beta-adrene rgic bronchodilator on diary cards daily. Investigators provided a glo bal assessment of asthma control at weeks 0, 4, 8, and 12. Standard la boratory tests, CBC count, serum chemistries, and urinalysis were obta ined at study start and end. Results: Adverse event reporting rates we re similar for the three treatment groups. The morning PEF tended to b e lower for the Proventil HFA and Ventolin groups than the HFA-134a pl acebo group, but the evening PEF tended to be higher for the active tr eatment groups. Daytime asthma symptom scores tended to be lower (bett er) with active treatment than placebo, but nighttime asthma sleep dis turbance scores were similar for all three treatment groups. Use of Ve ntolin Rotacaps HFA and Ventolin groups. Diary card data did not chang e within groups over time. Investigator global assessments of asthma s cores clustered between fair and good for all three treatment groups t hroughout the study. Changes in heart rate and BP were small after dos ing with study drug and tended to be similar for the active treatments and HFA-134a placebo groups. No clinically meaningful changes in resu lts of standard laboratory tests were found in any treatment group dur ing this study. Conclusions: Proventil HFA had a similar safety profil e as Ventolin during regular use. A dosage of 16 puffs per day to prop ellant HFA-134a was well tolerated by asthmatics. Regular use of eithe r Proventil HFA or Ventolin did not cause asthma control to deteriorat e.