Proventil HFA and ventolin have similar safety profiles during regular use.
OBJECTIVE
As a secondary objective to a long-term study evaluating the bronchodilator effectiveness of Proventil HFA (albuterol), to assess the safety of Proventil HFA, Ventolin, and hydrofluoroalkane 134a (HFA-134a) placebo over 12 weeks of regular dosing.


METHODS
Randomized, double-blind, double-dummy parallel group, placebo-controlled, multicenter trial of asthmatics requiring inhaled beta-adrenergic bronchodilators for symptom control.


METHODS
Treatment with Proventil HFA, Ventolin, or HFA-134a placebo, qid, for 12 weeks.


METHODS
Adverse events were reviewed at biweekly clinic visits. Between clinic visits, patients recorded morning and evening peak expiratory flow (PEF), asthma symptom and nighttime asthma sleep disturbance scores, and use of rescue beta-adrenergic bronchodilator on diary cards daily. Investigators provided a global assessment of asthma control at weeks 0, 4, 8, and 12. Vital signs were recorded over 6 h after dosing with study drug at weeks 0, 4, 8, and 12. Standard laboratory tests, CBC count, serum chemistries, and urinalysis were obtained at study start and end.


RESULTS
Adverse event reporting rates were similar for the three treatment groups. The morning PEF tended to be lower for the Proventil HFA and Ventolin groups than the HFA-134a placebo group, but the evening PEF tended to be higher for the active treatment groups. Daytime asthma symptom scores tended to be lower (better) with active treatment than placebo, but nighttime asthma sleep disturbance scores were similar for all three treatment groups. Use of Ventolin Rotacaps as rescue medication was significantly greater for the HFA-134a placebo group than the Proventil HFA and Ventolin groups. Diary card data did not change within groups over time. Investigator global assessments of asthma scores clustered between fair and good for all three treatment groups throughout the study. Changes in heart rate and BP were small after dosing with study drug and tended to be similar for the active treatments and HFA-134a placebo groups. No clinically meaningful changes in results of standard laboratory tests were found in any treatment group during this study.


CONCLUSIONS
Proventil HFA had a similar safety profile as Ventolin during regular use. A dosage of 16 puffs per day of propellant HFA-134a was well tolerated by asthmatics. Regular use of either Proventil HFA or Ventolin did not cause asthma control to deteriorate.
Tinkelman
D G
DG
Department of Medicine, University of Maryland, Baltimore, USA.
Bleecker
E R
ER
Ramsdell
J
J
Ekholm
B P
BP
Klinger
N M
NM
Colice
G L
GL
Slade
H B
HB
D000280:Administration, Inhalation; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000335:Aerosol Propellants; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology / Q000652:urine; D001772:Blood Cell Count; D001774:Blood Chemical Analysis; D001794:Blood Pressure / Q000187:drug effects; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D006261:Headache / Q000209:etiology; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006845:Hydrocarbons, Fluorinated; D008137:Longitudinal Studies; D008499:Medical Records; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate / Q000187:drug effects / Q000502:physiology; D010919:Placebos; D012141:Respiratory Tract Infections / Q000209:etiology; D012220:Rhinitis / Q000209:etiology; D012449:Safety; D012893:Sleep Wake Disorders / Q000503:physiopathology; D005466:Fluorocarbons
D000318:Adrenergic beta-Agonists; D000335:Aerosol Propellants; D000420:Albuterol; D001993:Bronchodilator Agents; D006845:Hydrocarbons, Fluorinated; D010919:Placebos; C094049:apaflurane; D005466:Fluorocarbons