Growth, systemic safety, and efficacy during 1 year of asthma treatment with different beclomethasone dipropionate formulations: an open-label, randomized comparison of extrafine and conventional aerosols in children.
OBJECTIVE
To assess the long-term safety of hydrofluoroalkane 134a (HFA)-beclomethasone dipropionate (BDP) extrafine aerosol administered by the Autohaler compared with chlorofluorocarbon (CFC)-BDP administered by a press-and-breathe metered-dose inhaler (pMDI) and spacer (+S) in the treatment of children with asthma.


METHODS
This 12-month, open-label, randomized, multicenter study enrolled 300 children who were aged 5 to 11 years and had well-controlled asthma on inhaled CFC-BDP or budesonide; 256 patients were using doses within the recommended range (200-400 microg) and were analyzed separately. Patients were randomized in a 1:3 ratio to continue on CFC-BDP+S at approximately the same dose as they were using before study entry or switch to HFA-BDP at half the daily dose.


RESULTS
Asthma control was well maintained in the HFA-BDP group as evidenced by lung function tests and asthma symptoms compared with CFC-BDP+S at approximately twice the dose. There were no significant differences between the HFA-BDP 100 to 200 microg and CFC-BDP+S 200 to 400 microg treatment groups in mean change from baseline in height (5.23 cm vs 5.66 cm at month 12, respectively) or mean growth velocity from day 1 to month 12 (5.27 cm/y vs 5.71 cm/y, respectively). There were no significant differences between groups in adrenal function tests or markers of bone metabolism.


CONCLUSIONS
In this long-term study in children with asthma, extrafine HFA-BDP provided long-term maintenance of asthma control at approximately half the dose compared with CFC-BDP+S. There were no clinically meaningful differences between HFA-BDP extrafine aerosol and conventional CFC-BDP+S with regard to growth or other systemic effects.
Pedersen
Søren
S
Paediatrisk Afdeling, Kolding Sygehus, Kolding, Denmark. spconsult@post1.tele.dk
Warner
John
J
Wahn
Ulrich
U
Staab
Doris
D
Le Bourgeois
Muriel
M
Van Essen-Zandvliet
Elisabeth
E
Arora
Sujata
S
Szefler
Stanley J
SJ
D000280:Administration, Inhalation; D000335:Aerosol Propellants / Q000008:administration & dosage; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002648:Child; D002657:Child Development / Q000187:drug effects; D002675:Child, Preschool; D017402:Chlorofluorocarbons / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006128:Growth / Q000187:drug effects*; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000008:administration & dosage; D008297:Male; D012129:Respiratory Function Tests; D016896:Treatment Outcome; D005466:Fluorocarbons
D000335:Aerosol Propellants; D018927:Anti-Asthmatic Agents; D001507:Beclomethasone; D019819:Budesonide; D017402:Chlorofluorocarbons; D006845:Hydrocarbons, Fluorinated; C094049:apaflurane; D005466:Fluorocarbons