Hs. Nelson et al., Long-term safety of a non-chlorofluorocarbon-containing triamcinolone acetonide inhalation aerosol in patients with asthma, J ASTHMA, 37(2), 2000, pp. 145-152
In response to environmental concerns regarding chlorofluorocarbon (CFC), t
wo new triamcinolone acetonide (TAA) inhalation aerosol (Azmacort Inhalatio
n Aerosol) formulations have been developed using a more environmentally fa
vorable propellant, HFA-134a (1,1,1,2-tetrafluoroethane). This multicenter,
open-label study evaluated the safety of switching asthma patients from TA
A-CFC to one of two TAA-HFA formulations. After a 2- or 4-week baseline per
iod during which patients received only CFC-containing TAA Inhaler, 552 pat
ients were randomized to receive TAA-HFA 75 or 225 mu g for 6 or 12 months.
A total of 493 patients completed treatment. Seven patients discontinued b
ecause of adverse events and two because of ineffective asthma control. The
incidence of adverse events was similar in the two treatment groups, and m
ost events were mild to moderate in severity and were not considered relate
d to study medication. No clinically relevant suppression of the hypophysea
l-pituitary-adrenal (HPA) axis was observed. Pulmonary function tests were
not adversely affected by use of either study medication, and improvements
were noted in forced expiratory volume in 1 sec (FEV1) and forced expirator
y flow between 25% and 75% of forced vital capacity (FEF25%-75%) throughout
the course of treatment. This study confirms that TAA-HFA provides effecti
ve, long-term asthma control and can safely be substituted for the currentl
y marketed CFC-containing TAA product.