TY - JOUR
T1 - A controlled trial of chlorofluorocarbon-free triamcinolone acetonide inhalation aerosol in the treatment of adult patients with persistent asthma
AU - Welch, Michael
AU - Bernstein, David
AU - Gross, Gary
AU - Kane, Robert E.
AU - Banerji, Donald
AU - Aaronson, Donald
AU - Offenberg, Howard
AU - Auerbach, Donald
AU - Oppenheimer, John
AU - Bell, Thomas
AU - Petroff, Peter
AU - Bensch, George
AU - Picone, Frank
AU - Berger, William
AU - Pollard, Stephen
AU - Bernstein, David
AU - Raphael, Gordon
AU - Caldwell, Jacques
AU - Rhodes, R. Robert
AU - Cohen, Robert
AU - Rosenthal, Richard
AU - Cosmo, Leonard
AU - Schenkel, Eric
AU - Demarco, Frank
AU - Segall, Nathan
AU - Edwards, Thomas
AU - Settipane, Guy
AU - Fineman, Stanley
AU - Silvers, William
AU - Goldstein, Marc
AU - Sim, Tommy
AU - Gross, Gary
AU - Sokol, William
AU - Henry, Dan
AU - Spector, Sheldon
AU - Jacobs, Robert
AU - Steinberg, Paul
AU - Kraemer, Michael
AU - Stricker, William
AU - LaForce, Craig
AU - Wein, M. Michael
AU - Martin, Bruce
AU - Welch, Michael
AU - Noonan, Michael
PY - 1999
Y1 - 1999
N2 - Study objective: To compare the dose response, efficacy, and safety of inhaled triamcinolone acetonide (TAA) with a hydrofluoroalkane (HFA) propellant (75 μg/puff), TAA with a chlorofluorocarbon propellant (dichlorodifluoromethane [P-12]; 75 μg/puff), and placebo in adult patients with persistent asthma. Design: Multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 514 adult patients with persistent asthma. Interventions and measurements: Patients received 8 weeks of treatment with 150, 300, or 600 μg/d of TAA HFA, the same doses of TAA P- 12, or placebo following a 5- to 21-day baseline period. Efficacy was assessed by spirometry, and by daily recordings of albuterol use, peak expiratory flow (PEF), asthma symptom ratings, and nighttime awakenings throughout the study. Results: Linear trend analysis showed that both formulations of TAA at all doses produced statistically significant improvements compared with placebo in spirometry, asthma symptom scores, albuterol use, and PEF. Significant improvement was seen as early as 24 h for morning PEF and as early as 1 week for FEV1 (TAA HFA, 600 μg/d; TAA P-12, 300 and 600 μg/d) and albuterol use (all doses of both formulations). The P- 12 and HFA formulations had comparable efficacy. A dose response showing greater improvement with higher doses was evident for the majority of parameters for both formulations. The incidences of adverse events were similar across all treatment groups with no dose-related trends. Conclusion: HFA and P-12 formulations of TAA inhalation aerosol were therapeutically equivalent and showed comparable safety and dose-related efficacy in the treatment of patients with persistent asthma.
AB - Study objective: To compare the dose response, efficacy, and safety of inhaled triamcinolone acetonide (TAA) with a hydrofluoroalkane (HFA) propellant (75 μg/puff), TAA with a chlorofluorocarbon propellant (dichlorodifluoromethane [P-12]; 75 μg/puff), and placebo in adult patients with persistent asthma. Design: Multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 514 adult patients with persistent asthma. Interventions and measurements: Patients received 8 weeks of treatment with 150, 300, or 600 μg/d of TAA HFA, the same doses of TAA P- 12, or placebo following a 5- to 21-day baseline period. Efficacy was assessed by spirometry, and by daily recordings of albuterol use, peak expiratory flow (PEF), asthma symptom ratings, and nighttime awakenings throughout the study. Results: Linear trend analysis showed that both formulations of TAA at all doses produced statistically significant improvements compared with placebo in spirometry, asthma symptom scores, albuterol use, and PEF. Significant improvement was seen as early as 24 h for morning PEF and as early as 1 week for FEV1 (TAA HFA, 600 μg/d; TAA P-12, 300 and 600 μg/d) and albuterol use (all doses of both formulations). The P- 12 and HFA formulations had comparable efficacy. A dose response showing greater improvement with higher doses was evident for the majority of parameters for both formulations. The incidences of adverse events were similar across all treatment groups with no dose-related trends. Conclusion: HFA and P-12 formulations of TAA inhalation aerosol were therapeutically equivalent and showed comparable safety and dose-related efficacy in the treatment of patients with persistent asthma.
KW - Asthma chlorofluorocarbon
KW - Dichlorodifluoromethane
KW - Hydrofluoroalkane- 134a
KW - Inhaled corticosteroids
KW - Triamcinolone acetonide
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U2 - 10.1378/chest.116.5.1304
DO - 10.1378/chest.116.5.1304
M3 - Article
C2 - 10559092
AN - SCOPUS:0032724689
SN - 0012-3692
VL - 116
SP - 1304
EP - 1312
JO - CHEST
JF - CHEST
IS - 5
ER -