A controlled trial of chlorofluorocarbon-free triamcinolone acetonide inhalation aerosol in the treatment of adult patients with persistent asthma

Michael Welch, David Bernstein, Gary Gross, Robert E. Kane, Donald Banerji, Donald Aaronson, Howard Offenberg, Donald Auerbach, John Oppenheimer, Thomas Bell, Peter Petroff, George Bensch, Frank Picone, William Berger, Stephen Pollard, David Bernstein, Gordon Raphael, Jacques Caldwell, R. Robert Rhodes, Robert Cohen & 24 others Richard R Rosenthal, Leonard Cosmo, Eric Schenkel, Frank Demarco, Nathan Segall, Thomas Edwards, Guy Settipane, Stanley Fineman, William Silvers, Marc Goldstein, Tommy Sim, Gary Gross, William Sokol, Dan Henry, Sheldon Spector, Robert Jacobs, Paul Steinberg, Michael Kraemer, William Stricker, Craig LaForce, M. Michael Wein, Bruce Martin, Michael Welch, Michael Noonan

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1304-1312
Number of pages9
JournalChest
Volume116
Issue number5
DOIs
StatePublished - 1999
Externally publishedYes

Fingerprint

HFA 134a
Chlorofluorocarbons
Triamcinolone Acetonide
Aerosols
Inhalation
Asthma
Albuterol
Placebos
Spirometry
Therapeutics
Safety

Keywords

  • Asthma chlorofluorocarbon
  • Dichlorodifluoromethane
  • Hydrofluoroalkane- 134a
  • Inhaled corticosteroids
  • Triamcinolone acetonide

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

A controlled trial of chlorofluorocarbon-free triamcinolone acetonide inhalation aerosol in the treatment of adult patients with persistent asthma. / Welch, Michael; Bernstein, David; Gross, Gary; Kane, Robert E.; Banerji, Donald; Aaronson, Donald; Offenberg, Howard; Auerbach, Donald; Oppenheimer, John; Bell, Thomas; Petroff, Peter; Bensch, George; Picone, Frank; Berger, William; Pollard, Stephen; Bernstein, David; Raphael, Gordon; Caldwell, Jacques; Rhodes, R. Robert; Cohen, Robert; Rosenthal, Richard R; Cosmo, Leonard; Schenkel, Eric; Demarco, Frank; Segall, Nathan; Edwards, Thomas; Settipane, Guy; Fineman, Stanley; Silvers, William; Goldstein, Marc; Sim, Tommy; Gross, Gary; Sokol, William; Henry, Dan; Spector, Sheldon; Jacobs, Robert; Steinberg, Paul; Kraemer, Michael; Stricker, William; LaForce, Craig; Wein, M. Michael; Martin, Bruce; Welch, Michael; Noonan, Michael.

In: Chest, Vol. 116, No. 5, 1999, p. 1304-1312.

Research output: Contribution to journalArticle

Welch, M, Bernstein, D, Gross, G, Kane, RE, Banerji, D, Aaronson, D, Offenberg, H, Auerbach, D, Oppenheimer, J, Bell, T, Petroff, P, Bensch, G, Picone, F, Berger, W, Pollard, S, Bernstein, D, Raphael, G, Caldwell, J, Rhodes, RR, Cohen, R, Rosenthal, RR, Cosmo, L, Schenkel, E, Demarco, F, Segall, N, Edwards, T, Settipane, G, Fineman, S, Silvers, W, Goldstein, M, Sim, T, Gross, G, Sokol, W, Henry, D, Spector, S, Jacobs, R, Steinberg, P, Kraemer, M, Stricker, W, LaForce, C, Wein, MM, Martin, B, Welch, M & Noonan, M 1999, 'A controlled trial of chlorofluorocarbon-free triamcinolone acetonide inhalation aerosol in the treatment of adult patients with persistent asthma', Chest, vol. 116, no. 5, pp. 1304-1312. https://doi.org/10.1378/chest.116.5.1304
Welch, Michael ; Bernstein, David ; Gross, Gary ; Kane, Robert E. ; Banerji, Donald ; Aaronson, Donald ; Offenberg, Howard ; Auerbach, Donald ; Oppenheimer, John ; Bell, Thomas ; Petroff, Peter ; Bensch, George ; Picone, Frank ; Berger, William ; Pollard, Stephen ; Bernstein, David ; Raphael, Gordon ; Caldwell, Jacques ; Rhodes, R. Robert ; Cohen, Robert ; Rosenthal, Richard R ; Cosmo, Leonard ; Schenkel, Eric ; Demarco, Frank ; Segall, Nathan ; Edwards, Thomas ; Settipane, Guy ; Fineman, Stanley ; Silvers, William ; Goldstein, Marc ; Sim, Tommy ; Gross, Gary ; Sokol, William ; Henry, Dan ; Spector, Sheldon ; Jacobs, Robert ; Steinberg, Paul ; Kraemer, Michael ; Stricker, William ; LaForce, Craig ; Wein, M. Michael ; Martin, Bruce ; Welch, Michael ; Noonan, Michael. / A controlled trial of chlorofluorocarbon-free triamcinolone acetonide inhalation aerosol in the treatment of adult patients with persistent asthma. In: Chest. 1999 ; Vol. 116, No. 5. pp. 1304-1312.
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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 R

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

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KW - Asthma chlorofluorocarbon

KW - Dichlorodifluoromethane

KW - Hydrofluoroalkane- 134a

KW - Inhaled corticosteroids

KW - Triamcinolone acetonide

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