Effective control of asthma with hydrofluoroalkane flunisolide delivered as an extrafine aerosol in asthma patients.
BACKGROUND
Inhaled corticosteroids are established as maintenance therapy for persistent asthma. A new aerosol formulation of flunisolide delivers a small particle size by using a hydrofluoroalkane (HFA) propellant with a built-in spacer.


OBJECTIVE
To compare efficacy and safety of two different flunisolide formulations, HFA and chlorofluorocarbon (CFC), with placebo treatment over a range of doses.


METHODS
The multicenter, randomized, double-blind, placebo-controlled trial consisted of a 2-week, active run-in phase with CFC flunisolide 500 microg, twice daily, followed by 12 weeks of double-blind treatment with placebo, HFA flunisolide (85, 170, or 340 microg, twice daily), or CFC flunisolide (250, 500, or 1,000 microg, twice daily). Patients (N = 669) were nonsmokers, at least 12 years of age, with mild to moderate asthma who were being treated with inhaled corticosteroids. Outcome measures were change from baseline in forced expiratory volume in 1 second (FEV1), peak expiratory flow rate, as needed albuterol use, nocturnal awakenings, and asthma symptoms.


RESULTS
After 12 weeks of treatment, patients receiving 170 microg, twice daily, and 340 microg, twice daily, of HFA flunisolide showed a significant (P < 0.01) improvement in percentage increase in FEV1 (12.22% at 170 microg, twice daily, and 14.69% at 340 microg, twice daily) compared with the placebo group (5.35%). At one-third the dose of CFC flunisolide, HFA flunisolide provided similar improvement in pulmonary function versus placebo. Both formulations demonstrated comparable linear dose dependency for the change from baseline in FEV1 without any evidence of cortisol suppression. Outcome values for all seven secondary efficacy measures were numerically superior in patients receiving HFA flunisolide compared with the CFC formulation. Both formulations seemed to be safe and well tolerated.


CONCLUSIONS
HFA flunisolide provides comparable efficacy and safety at one-third the dose of CFC flunisolide.
Corren
J
J
Allergy Research Foundation, Inc., Los Angeles, California 90023, USA. joncorren@hotmail.com
Nelson
H
H
Greos
L S
LS
Bensch
G
G
Goldstein
M
M
Wu
J
J
Wang
S
S
Newman
K
K
D000280:Administration, Inhalation; D000311:Adrenal Glands / Q000187:drug effects; D000328:Adult; D000335:Aerosol Propellants / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000378:metabolism; D017402:Chlorofluorocarbons / Q000627:therapeutic use; D003366:Cosyntropin; D004305:Dose-Response Relationship, Drug; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000627:therapeutic use*; D006854:Hydrocortisone / Q000378:metabolism; D008297:Male; D010316:Particle Size; D010366:Peak Expiratory Flow Rate / Q000187:drug effects
D000335:Aerosol Propellants; D018927:Anti-Asthmatic Agents; D017402:Chlorofluorocarbons; D006845:Hydrocarbons, Fluorinated; D005446:Fluocinolone Acetonide; D003366:Cosyntropin; C007734:flunisolide; D006854:Hydrocortisone