- Email: [email protected]
Early onset of effect of salmeterol and fluticasone propionate in chronic obstructive pulmonary disease
ARTICLE IN PRESS Smoking and COPD
67
Background: COPD has a severe impact on patient quality of life. AM3 is an orally effective immunomodulator that can normalize the defective antimicrobial functions of the immune system effector cells of COPD patients. Objectives: We analyzed the effect of AM3 on exacerbation frequency and health-related quality of life (HRQL) of COPD patients with moderate disease. Design: A randomized, double-blind, placebo-controlled trial. Setting: Outpatient departments of 21 hospitals. Methods: A total of 253 COPD patients with a mean age of 67.7 years (SD, 8.1 years) and mean FEV(1) percentage of predicted of 49.6% (SD, 10.2%) were evaluated. Patients received (orally) either 3 g/d AM3 or a matched placebo for 180 consecutive days. Patient quality of life was measured using the St. George’s Respiratory Questionnaire (SGRQ). Results: There were no differences in the exacerbation frequency of the two groups (0.82 episodes per patient in the AM3 arm vs. 0.84 in the placebo arm), and 55.3% of patients were exacerbation free in the AM3 arm compared to 48.8% in the placebo arm ðP ¼ 0:11Þ: At the end of treatment, quality of life was significantly better in the AM3 arm than in the placebo arm (SGRQ total score, 32.9; SD, 16.4, compared to 37.5; SD, 17.5 [Po0.05]: activity score, 47.5; SD, 22.4, compared to 54.6; SD, 20.5 [Po0.05]). The improvements in total SGRQ scores were 8.9 U (SD, 13.4 U) in the AM3 arm and 5.6 U (SD, 15.9 U) in the placebo arm ðP ¼ 0:076Þ: Improvements on the symptoms subscale were 15.9 U (SD, 20.7 U) for the AM3 arm and 10.2 U (SD, 21.3 U) for the placebo arm (Po0.05). Both AM3 and the placebo were clinically, biochemically, and hematologically well tolerated. Conclusions: AM3 is a safe, easily tolerated, effective treatment that improves the quality of life of COPD patients as measured by SGRQ scores. This effect was observed with no significant reduction in the frequency of exacerbations.
Background: Combined treatment with inhaled corticosteroids and long acting b2 agonists is approved for the treatment of chronic obstructive pulmonary disease (COPD), but little is known about the onset of effect of the combination. Methods: Data were used from 1465 patients with COPD entered into a large 1 year double blind trial with daily measurements of peak expiratory flow (PEF) and symptom scores. Results: PEF was significantly higher after 1 day in patients treated with salmeterol 50 mg twice daily or the salmeterol/fluticasone propionate combination 50/ 500 mg twice daily than placebo. In patients treated with fluticasone propionate 500 mg twice daily alone, PEF differed from placebo after 2 days. The differences after 2 weeks compared with placebo were 16 l/min (95% confidence interval (CI) 11–21), 11 l/min (95% CI 6–16), and 27 l/min (95% CI 22–33) for salmeterol, fluticasone propionate, and the salmeterol/fluticasone propionate combination, respectively. For all treatments the effect on PEF after 2 weeks was comparable to that seen at the end of the study. The difference between the salmeterol/ fluticasone propionate combination and placebo after 2 weeks as a percentage of baseline was similar for PEF and clinic forced expiratory volume in 1 s (FEV1). Differences in breathlessness scores were statistically significant after 1 day for the group treated with salmeterol alone and after 2 days for the combination group. The 2 week change in FEV1 was only partly indicative of a long-term response in individual patients. Conclusions: The effects of salmeterol and fluticasone propionate, alone or in combination, on PEF and breathlessness are seen within days and most of the obtainable effect on these parameters is reached within 2 weeks.
& 2005 American College of Chest Physicians. Reproduced with permission.
Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: A randomised controlled trial Thorax 2005;60:480–7.
doi: 10.1016/j.rmedu.2005.09.022
Early onset of effect of salmeterol and fluticasone propionate in chronic obstructive pulmonary disease Thorax 2005;60:301–4 J. Vestbo, R. Pauwels, J.A. Anderson, P. Jones, P. Calverley, on behalf of the TRISTAN study group
Reproduced with permission from the BMJ Publishing Group. doi: 10.1016/j.rmedu.2005.09.023
E.F.M. Wouters, D.S. Postma, B. Fokkens, W.C.J. Hop, J. Prins, A.F. Kuipers, H.R. Pasma, C.A.J. Hensing, E.C. Creutzberg, for the COSMIC (COPD and Seretide: a Multi-Center Intervention and Characterization) Study Group
North West Lung Centre, Wythenshawe Hospital, Manchester M23 9LT, UK
Department of Respiratory Medicine, University Hospital Maastricht, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands
E-mail address: [email protected] (J. Vestbo).
E-mail address: [email protected] (E.C. Creutzberg).
67
Background: COPD has a severe impact on patient quality of life. AM3 is an orally effective immunomodulator that can normalize the defective antimicrobial functions of the immune system effector cells of COPD patients. Objectives: We analyzed the effect of AM3 on exacerbation frequency and health-related quality of life (HRQL) of COPD patients with moderate disease. Design: A randomized, double-blind, placebo-controlled trial. Setting: Outpatient departments of 21 hospitals. Methods: A total of 253 COPD patients with a mean age of 67.7 years (SD, 8.1 years) and mean FEV(1) percentage of predicted of 49.6% (SD, 10.2%) were evaluated. Patients received (orally) either 3 g/d AM3 or a matched placebo for 180 consecutive days. Patient quality of life was measured using the St. George’s Respiratory Questionnaire (SGRQ). Results: There were no differences in the exacerbation frequency of the two groups (0.82 episodes per patient in the AM3 arm vs. 0.84 in the placebo arm), and 55.3% of patients were exacerbation free in the AM3 arm compared to 48.8% in the placebo arm ðP ¼ 0:11Þ: At the end of treatment, quality of life was significantly better in the AM3 arm than in the placebo arm (SGRQ total score, 32.9; SD, 16.4, compared to 37.5; SD, 17.5 [Po0.05]: activity score, 47.5; SD, 22.4, compared to 54.6; SD, 20.5 [Po0.05]). The improvements in total SGRQ scores were 8.9 U (SD, 13.4 U) in the AM3 arm and 5.6 U (SD, 15.9 U) in the placebo arm ðP ¼ 0:076Þ: Improvements on the symptoms subscale were 15.9 U (SD, 20.7 U) for the AM3 arm and 10.2 U (SD, 21.3 U) for the placebo arm (Po0.05). Both AM3 and the placebo were clinically, biochemically, and hematologically well tolerated. Conclusions: AM3 is a safe, easily tolerated, effective treatment that improves the quality of life of COPD patients as measured by SGRQ scores. This effect was observed with no significant reduction in the frequency of exacerbations.
Background: Combined treatment with inhaled corticosteroids and long acting b2 agonists is approved for the treatment of chronic obstructive pulmonary disease (COPD), but little is known about the onset of effect of the combination. Methods: Data were used from 1465 patients with COPD entered into a large 1 year double blind trial with daily measurements of peak expiratory flow (PEF) and symptom scores. Results: PEF was significantly higher after 1 day in patients treated with salmeterol 50 mg twice daily or the salmeterol/fluticasone propionate combination 50/ 500 mg twice daily than placebo. In patients treated with fluticasone propionate 500 mg twice daily alone, PEF differed from placebo after 2 days. The differences after 2 weeks compared with placebo were 16 l/min (95% confidence interval (CI) 11–21), 11 l/min (95% CI 6–16), and 27 l/min (95% CI 22–33) for salmeterol, fluticasone propionate, and the salmeterol/fluticasone propionate combination, respectively. For all treatments the effect on PEF after 2 weeks was comparable to that seen at the end of the study. The difference between the salmeterol/ fluticasone propionate combination and placebo after 2 weeks as a percentage of baseline was similar for PEF and clinic forced expiratory volume in 1 s (FEV1). Differences in breathlessness scores were statistically significant after 1 day for the group treated with salmeterol alone and after 2 days for the combination group. The 2 week change in FEV1 was only partly indicative of a long-term response in individual patients. Conclusions: The effects of salmeterol and fluticasone propionate, alone or in combination, on PEF and breathlessness are seen within days and most of the obtainable effect on these parameters is reached within 2 weeks.
& 2005 American College of Chest Physicians. Reproduced with permission.
Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: A randomised controlled trial Thorax 2005;60:480–7.
doi: 10.1016/j.rmedu.2005.09.022
Early onset of effect of salmeterol and fluticasone propionate in chronic obstructive pulmonary disease Thorax 2005;60:301–4 J. Vestbo, R. Pauwels, J.A. Anderson, P. Jones, P. Calverley, on behalf of the TRISTAN study group
Reproduced with permission from the BMJ Publishing Group. doi: 10.1016/j.rmedu.2005.09.023
E.F.M. Wouters, D.S. Postma, B. Fokkens, W.C.J. Hop, J. Prins, A.F. Kuipers, H.R. Pasma, C.A.J. Hensing, E.C. Creutzberg, for the COSMIC (COPD and Seretide: a Multi-Center Intervention and Characterization) Study Group
North West Lung Centre, Wythenshawe Hospital, Manchester M23 9LT, UK
Department of Respiratory Medicine, University Hospital Maastricht, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands
E-mail address: [email protected] (J. Vestbo).
E-mail address: [email protected] (E.C. Creutzberg).