Placebo-controlled, comparative study of the efficacy and safety of triamcinolone acetonide inhalation aerosol with the non-CFC propellant HFA-134a in patients with asthma. Azmacort HFA Clinical Study Group.
BACKGROUND
Triamcinolone acetonide (TAA) inhalation aerosol (Azmacort Inhalation Aerosol), a well-established corticosteroid treatment for bronchial asthma, utilizes the chlorofluorocarbon (CFC) propellant P-12, which will be phased out because of environmental concerns. Two TAA aerosol formulations have been developed using a non-chlorofluorocarbon propellant, HFA-134a (Azmacort HFA Inhalation Aerosol delivering TAA 75 microg/puff or 225 microg/puff).


OBJECTIVE
This study compared the efficacy and safety of the new 225 microg/puff formulation (TAA-HFA 225) to the marketed TAA inhalation aerosol (TAA-CFC) and to placebo in adult patients with moderate-to-severe persistent asthma.


METHODS
After a 5-day to 21-day baseline period during which all patients received TAA-CFC 150 microg/day, 538 patients were randomized to one of the following treatment schedules: TAA-HFA 450, 900, or 1800 microg/day; TAA-CFC 450 or 900 microg/day; or placebo for 12 weeks.


RESULTS
All active treatment groups showed statistically significant improvement compared with placebo in pulmonary function (FEV1, FEF25-75%, morning and evening PEF), use of rescue albuterol, and asthma symptom scores. Improvements in all variables occurred within 1 week of treatment.


CONCLUSIONS
The TAA-HFA 225 exhibited similar safety and efficacy profiles to the two equivalent doses of TAA-CFC studied. Our findings indicate that TAA-HFA is a safe and effective replacement for the currently marketed CFC-containing product. The higher strength 225 microg/puff formulation provides effective control of asthma with fewer inhalations.
Jacobson
K
K
Allergy and Asthma Research Group, Eugene, Oregon, USA.
Chervinsky
P
P
Noonan
M
M
Kane
R E
RE
Banerji
D
D
Uryniak
T
T
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000335:Aerosol Propellants / Q000009:adverse effects; D000336:Aerosols; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D017402:Chlorofluorocarbons / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005541:Forced Expiratory Volume; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012449:Safety; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005466:Fluorocarbons
D000335:Aerosol Propellants; D000336:Aerosols; D000420:Albuterol; D018927:Anti-Asthmatic Agents; D017402:Chlorofluorocarbons; D005938:Glucocorticoids; D006845:Hydrocarbons, Fluorinated; D014222:Triamcinolone Acetonide; C094049:apaflurane; D005466:Fluorocarbons