Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol

A randomized controlled trial

Robert F. Lemanske, Christine A. Sorkness, Elizabeth A. Mauger, Stephen C. Lazarus, Homer A. Boushey, John V. Fahy, Jeffrey M. Drazen, Vernon M. Chinchilli, Timothy Craig, James E. Fish, Jean G. Ford, Elliot Israel, Monica Kraft, Richard J. Martin, Sami A. Nachman, Stephen P. Peters, Joseph D. Spahn, Stanley J. Szefler

Research output: Contribution to journalArticle

249 Citations (Scopus)

Abstract

Context: Inhaled long-acting β2-agonists improve asthma control when added to inhaled corticosteroid (ICS) therapy. Objective: To determine whether ICS therapy can be reduced or eliminated in patients with persistent asthma after adding a long-acting β2-agonist to their treatment regimen. Design and Setting: A 24-week randomized, controlled, blinded, double-dummy, parallel-group trial conducted at 6 National Institutes of Health-sponsored, university-based ambulatory care centers from February 1997 through January 1999. Participants: One hundred seventy-five patients aged 12 through 65 years with persistent asthma that was suboptimally controlled during a 6-week run-in period of treatment with inhaled triamcinolone acetonide (400 μg twice per day). Intervention: Patients continued triamcinolone therapy and were randomly assigned to receive add-on therapy with either placebo (placebo-minus group, n=21) or salmeterol xinafoate, 42 μg twice per day (n = 154) for 2 weeks. The entire placebo-minus group was assigned and half of the salmeterol group (salmeterol-minus group) was randomly assigned to reduce by 50% (for 8 weeks) then eliminate (for 8 weeks) triamcinolone treatment. The other half of the salmeterol group (salmeterol-plus group) was randomly assigned to continue both salmeterol and triamcinolone for the remaining 16 weeks (active control group). Main Outcome Measure: Time to asthma treatment failure in patients receiving salmeterol. Results: Treatment failure occurred in 8.3 % (95% confidence interval [CI], 2%-15%) of the salmeterol-minus group 8 weeks after triamcinolone treatment was reduced compared with 2.8% (95% CI, 0%-7%) of the salmeterol-plus group during the same period. Treatment failure occurred in 46.3% (95% CI, 34%-59%) of the salmeterol-minus group 8 weeks after triamcinolone therapy was eliminated compared with 13.7% (95% CI, 5%-22%) of the salmeterol-plus group. The relative risk (95% CI) of treatment failure at the end of the triamcinolone elimination phase in the salmeterol-minus group was 4.3 (2.0-9.2) compared with the salmeterol-plus group (P<.001). Conclusions: Our results indicate that in patients with persistent asthma suboptimally controlled by triamcinolone therapy alone but whose asthma symptoms improve after addition of salmeterol, a substantial reduction (50%) in triamcinolone dose can occur without a significant loss of asthma control. However, total elimination of triamcinolone therapy results in a significant deterioration in asthma control and, therefore, cannot be recommended.

Original languageEnglish (US)
Pages (from-to)2594-2603
Number of pages10
JournalJournal of the American Medical Association
Volume285
Issue number20
StatePublished - May 23 2001
Externally publishedYes

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Triamcinolone
Adrenal Cortex Hormones
Asthma
Randomized Controlled Trials
Treatment Failure
Confidence Intervals
Therapeutics
Placebos
Salmeterol Xinafoate
Triamcinolone Acetonide
National Institutes of Health (U.S.)
Ambulatory Care
Outcome Assessment (Health Care)
Control Groups

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Lemanske, R. F., Sorkness, C. A., Mauger, E. A., Lazarus, S. C., Boushey, H. A., Fahy, J. V., ... Szefler, S. J. (2001). Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol: A randomized controlled trial. Journal of the American Medical Association, 285(20), 2594-2603.

Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol : A randomized controlled trial. / Lemanske, Robert F.; Sorkness, Christine A.; Mauger, Elizabeth A.; Lazarus, Stephen C.; Boushey, Homer A.; Fahy, John V.; Drazen, Jeffrey M.; Chinchilli, Vernon M.; Craig, Timothy; Fish, James E.; Ford, Jean G.; Israel, Elliot; Kraft, Monica; Martin, Richard J.; Nachman, Sami A.; Peters, Stephen P.; Spahn, Joseph D.; Szefler, Stanley J.

In: Journal of the American Medical Association, Vol. 285, No. 20, 23.05.2001, p. 2594-2603.

Research output: Contribution to journalArticle

Lemanske, RF, Sorkness, CA, Mauger, EA, Lazarus, SC, Boushey, HA, Fahy, JV, Drazen, JM, Chinchilli, VM, Craig, T, Fish, JE, Ford, JG, Israel, E, Kraft, M, Martin, RJ, Nachman, SA, Peters, SP, Spahn, JD & Szefler, SJ 2001, 'Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol: A randomized controlled trial', Journal of the American Medical Association, vol. 285, no. 20, pp. 2594-2603.
Lemanske, Robert F. ; Sorkness, Christine A. ; Mauger, Elizabeth A. ; Lazarus, Stephen C. ; Boushey, Homer A. ; Fahy, John V. ; Drazen, Jeffrey M. ; Chinchilli, Vernon M. ; Craig, Timothy ; Fish, James E. ; Ford, Jean G. ; Israel, Elliot ; Kraft, Monica ; Martin, Richard J. ; Nachman, Sami A. ; Peters, Stephen P. ; Spahn, Joseph D. ; Szefler, Stanley J. / Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol : A randomized controlled trial. In: Journal of the American Medical Association. 2001 ; Vol. 285, No. 20. pp. 2594-2603.
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abstract = "Context: Inhaled long-acting β2-agonists improve asthma control when added to inhaled corticosteroid (ICS) therapy. Objective: To determine whether ICS therapy can be reduced or eliminated in patients with persistent asthma after adding a long-acting β2-agonist to their treatment regimen. Design and Setting: A 24-week randomized, controlled, blinded, double-dummy, parallel-group trial conducted at 6 National Institutes of Health-sponsored, university-based ambulatory care centers from February 1997 through January 1999. Participants: One hundred seventy-five patients aged 12 through 65 years with persistent asthma that was suboptimally controlled during a 6-week run-in period of treatment with inhaled triamcinolone acetonide (400 μg twice per day). Intervention: Patients continued triamcinolone therapy and were randomly assigned to receive add-on therapy with either placebo (placebo-minus group, n=21) or salmeterol xinafoate, 42 μg twice per day (n = 154) for 2 weeks. The entire placebo-minus group was assigned and half of the salmeterol group (salmeterol-minus group) was randomly assigned to reduce by 50{\%} (for 8 weeks) then eliminate (for 8 weeks) triamcinolone treatment. The other half of the salmeterol group (salmeterol-plus group) was randomly assigned to continue both salmeterol and triamcinolone for the remaining 16 weeks (active control group). Main Outcome Measure: Time to asthma treatment failure in patients receiving salmeterol. Results: Treatment failure occurred in 8.3 {\%} (95{\%} confidence interval [CI], 2{\%}-15{\%}) of the salmeterol-minus group 8 weeks after triamcinolone treatment was reduced compared with 2.8{\%} (95{\%} CI, 0{\%}-7{\%}) of the salmeterol-plus group during the same period. Treatment failure occurred in 46.3{\%} (95{\%} CI, 34{\%}-59{\%}) of the salmeterol-minus group 8 weeks after triamcinolone therapy was eliminated compared with 13.7{\%} (95{\%} CI, 5{\%}-22{\%}) of the salmeterol-plus group. The relative risk (95{\%} CI) of treatment failure at the end of the triamcinolone elimination phase in the salmeterol-minus group was 4.3 (2.0-9.2) compared with the salmeterol-plus group (P<.001). Conclusions: Our results indicate that in patients with persistent asthma suboptimally controlled by triamcinolone therapy alone but whose asthma symptoms improve after addition of salmeterol, a substantial reduction (50{\%}) in triamcinolone dose can occur without a significant loss of asthma control. However, total elimination of triamcinolone therapy results in a significant deterioration in asthma control and, therefore, cannot be recommended.",
author = "Lemanske, {Robert F.} and Sorkness, {Christine A.} and Mauger, {Elizabeth A.} and Lazarus, {Stephen C.} and Boushey, {Homer A.} and Fahy, {John V.} and Drazen, {Jeffrey M.} and Chinchilli, {Vernon M.} and Timothy Craig and Fish, {James E.} and Ford, {Jean G.} and Elliot Israel and Monica Kraft and Martin, {Richard J.} and Nachman, {Sami A.} and Peters, {Stephen P.} and Spahn, {Joseph D.} and Szefler, {Stanley J.}",
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TY - JOUR

T1 - Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol

T2 - A randomized controlled trial

AU - Lemanske, Robert F.

AU - Sorkness, Christine A.

AU - Mauger, Elizabeth A.

AU - Lazarus, Stephen C.

AU - Boushey, Homer A.

AU - Fahy, John V.

AU - Drazen, Jeffrey M.

AU - Chinchilli, Vernon M.

AU - Craig, Timothy

AU - Fish, James E.

AU - Ford, Jean G.

AU - Israel, Elliot

AU - Kraft, Monica

AU - Martin, Richard J.

AU - Nachman, Sami A.

AU - Peters, Stephen P.

AU - Spahn, Joseph D.

AU - Szefler, Stanley J.

PY - 2001/5/23

Y1 - 2001/5/23

N2 - Context: Inhaled long-acting β2-agonists improve asthma control when added to inhaled corticosteroid (ICS) therapy. Objective: To determine whether ICS therapy can be reduced or eliminated in patients with persistent asthma after adding a long-acting β2-agonist to their treatment regimen. Design and Setting: A 24-week randomized, controlled, blinded, double-dummy, parallel-group trial conducted at 6 National Institutes of Health-sponsored, university-based ambulatory care centers from February 1997 through January 1999. Participants: One hundred seventy-five patients aged 12 through 65 years with persistent asthma that was suboptimally controlled during a 6-week run-in period of treatment with inhaled triamcinolone acetonide (400 μg twice per day). Intervention: Patients continued triamcinolone therapy and were randomly assigned to receive add-on therapy with either placebo (placebo-minus group, n=21) or salmeterol xinafoate, 42 μg twice per day (n = 154) for 2 weeks. The entire placebo-minus group was assigned and half of the salmeterol group (salmeterol-minus group) was randomly assigned to reduce by 50% (for 8 weeks) then eliminate (for 8 weeks) triamcinolone treatment. The other half of the salmeterol group (salmeterol-plus group) was randomly assigned to continue both salmeterol and triamcinolone for the remaining 16 weeks (active control group). Main Outcome Measure: Time to asthma treatment failure in patients receiving salmeterol. Results: Treatment failure occurred in 8.3 % (95% confidence interval [CI], 2%-15%) of the salmeterol-minus group 8 weeks after triamcinolone treatment was reduced compared with 2.8% (95% CI, 0%-7%) of the salmeterol-plus group during the same period. Treatment failure occurred in 46.3% (95% CI, 34%-59%) of the salmeterol-minus group 8 weeks after triamcinolone therapy was eliminated compared with 13.7% (95% CI, 5%-22%) of the salmeterol-plus group. The relative risk (95% CI) of treatment failure at the end of the triamcinolone elimination phase in the salmeterol-minus group was 4.3 (2.0-9.2) compared with the salmeterol-plus group (P<.001). Conclusions: Our results indicate that in patients with persistent asthma suboptimally controlled by triamcinolone therapy alone but whose asthma symptoms improve after addition of salmeterol, a substantial reduction (50%) in triamcinolone dose can occur without a significant loss of asthma control. However, total elimination of triamcinolone therapy results in a significant deterioration in asthma control and, therefore, cannot be recommended.

AB - Context: Inhaled long-acting β2-agonists improve asthma control when added to inhaled corticosteroid (ICS) therapy. Objective: To determine whether ICS therapy can be reduced or eliminated in patients with persistent asthma after adding a long-acting β2-agonist to their treatment regimen. Design and Setting: A 24-week randomized, controlled, blinded, double-dummy, parallel-group trial conducted at 6 National Institutes of Health-sponsored, university-based ambulatory care centers from February 1997 through January 1999. Participants: One hundred seventy-five patients aged 12 through 65 years with persistent asthma that was suboptimally controlled during a 6-week run-in period of treatment with inhaled triamcinolone acetonide (400 μg twice per day). Intervention: Patients continued triamcinolone therapy and were randomly assigned to receive add-on therapy with either placebo (placebo-minus group, n=21) or salmeterol xinafoate, 42 μg twice per day (n = 154) for 2 weeks. The entire placebo-minus group was assigned and half of the salmeterol group (salmeterol-minus group) was randomly assigned to reduce by 50% (for 8 weeks) then eliminate (for 8 weeks) triamcinolone treatment. The other half of the salmeterol group (salmeterol-plus group) was randomly assigned to continue both salmeterol and triamcinolone for the remaining 16 weeks (active control group). Main Outcome Measure: Time to asthma treatment failure in patients receiving salmeterol. Results: Treatment failure occurred in 8.3 % (95% confidence interval [CI], 2%-15%) of the salmeterol-minus group 8 weeks after triamcinolone treatment was reduced compared with 2.8% (95% CI, 0%-7%) of the salmeterol-plus group during the same period. Treatment failure occurred in 46.3% (95% CI, 34%-59%) of the salmeterol-minus group 8 weeks after triamcinolone therapy was eliminated compared with 13.7% (95% CI, 5%-22%) of the salmeterol-plus group. The relative risk (95% CI) of treatment failure at the end of the triamcinolone elimination phase in the salmeterol-minus group was 4.3 (2.0-9.2) compared with the salmeterol-plus group (P<.001). Conclusions: Our results indicate that in patients with persistent asthma suboptimally controlled by triamcinolone therapy alone but whose asthma symptoms improve after addition of salmeterol, a substantial reduction (50%) in triamcinolone dose can occur without a significant loss of asthma control. However, total elimination of triamcinolone therapy results in a significant deterioration in asthma control and, therefore, cannot be recommended.

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