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The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD.
Chest. 2003 Sep; 124(3):834-43.Chest

Abstract

STUDY OBJECTIVES

To compare the efficacy and safety of the inhaled corticosteroid fluticasone propionate (FP) and the inhaled long-acting beta(2)-agonist salmeterol (SM), when administered together in a single device (Diskus; GlaxoSmithKline, Inc; Research Triangle Park, NC), with that of placebo and the individual agents alone in patients with COPD.

DESIGN

Randomized, double-blind, multicenter, placebo-controlled study.

SETTING

Seventy-six investigative sites in the United States.

PATIENTS

Seven hundred twenty-three patients > or =40 years of age with COPD and a mean baseline FEV(1) of 42% predicted.

INTERVENTIONS

FP (250 microg), SM (50 microg), FP plus SM combined in a single inhaler (FSC), or placebo administered twice daily through the Diskus device for 24 weeks.

MEASUREMENTS

Primary efficacy measures were morning predose (ie, trough FEV(1)) for FSC compared with SM and 2-h postdose FEV(1) for FSC compared with FP. Other efficacy measures were as follows: morning peak expiratory flow rate (PEF); transition dyspnea index; chronic respiratory disease questionnaire; chronic bronchitis symptom questionnaire; exacerbations; and other symptomatic measures.

RESULTS

At Endpoint (ie, the last on-treatment, post-baseline assessment), treatment with FSC significantly (p < or = 0.012) increased the morning predose FEV(1) (165 mL) compared with SM (91 mL) and placebo (1 mL), and significantly (p < or = 0.001) increased the 2-h postdose FEV(1) (281 mL) compared with FP (147 mL) and placebo (58 mL). Improvements in lung function with FSC compared with FP and SM, and with FP and SM compared with placebo, as measured by the average daily morning PEF, was observed within approximately 24 h after the initiation of treatment, indicating an early onset of effect (p < or = 0.034). Compared with placebo, FSC significantly improved dyspnea, quality of life, and symptoms of chronic bronchitis. The incidence of adverse effects (except for an increase in oral candidiasis with FSC and FP) were similar among the treatment groups.

CONCLUSIONS

Treatment with FSC (FP, 250 microg, and SM, 50 microg) twice daily substantially improved morning lung function and sustained these improvements for over a period of 24 weeks compared with FP or SM treatment alone in patients with COPD, with no additional safety concerns for the combination treatment vs that with the individual components.

Authors+Show Affiliations

Baylor College of Medicine, Pulmonary/Critical Care, Ben Taub General Hospital, 1504 Taub Loop, Houston, TX 77030, USA. hanania@bcm.tmc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12970006

Citation

Hanania, Nicola A., et al. "The Efficacy and Safety of Fluticasone Propionate (250 Microg)/salmeterol (50 Microg) Combined in the Diskus Inhaler for the Treatment of COPD." Chest, vol. 124, no. 3, 2003, pp. 834-43.
Hanania NA, Darken P, Horstman D, et al. The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD. Chest. 2003;124(3):834-43.
Hanania, N. A., Darken, P., Horstman, D., Reisner, C., Lee, B., Davis, S., & Shah, T. (2003). The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD. Chest, 124(3), 834-43.
Hanania NA, et al. The Efficacy and Safety of Fluticasone Propionate (250 Microg)/salmeterol (50 Microg) Combined in the Diskus Inhaler for the Treatment of COPD. Chest. 2003;124(3):834-43. PubMed PMID: 12970006.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD. AU - Hanania,Nicola A, AU - Darken,Patrick, AU - Horstman,Donald, AU - Reisner,Colin, AU - Lee,Benjamin, AU - Davis,Suzanne, AU - Shah,Tushar, PY - 2003/9/13/pubmed PY - 2003/10/16/medline PY - 2003/9/13/entrez SP - 834 EP - 43 JF - Chest JO - Chest VL - 124 IS - 3 N2 - STUDY OBJECTIVES: To compare the efficacy and safety of the inhaled corticosteroid fluticasone propionate (FP) and the inhaled long-acting beta(2)-agonist salmeterol (SM), when administered together in a single device (Diskus; GlaxoSmithKline, Inc; Research Triangle Park, NC), with that of placebo and the individual agents alone in patients with COPD. DESIGN: Randomized, double-blind, multicenter, placebo-controlled study. SETTING: Seventy-six investigative sites in the United States. PATIENTS: Seven hundred twenty-three patients > or =40 years of age with COPD and a mean baseline FEV(1) of 42% predicted. INTERVENTIONS: FP (250 microg), SM (50 microg), FP plus SM combined in a single inhaler (FSC), or placebo administered twice daily through the Diskus device for 24 weeks. MEASUREMENTS: Primary efficacy measures were morning predose (ie, trough FEV(1)) for FSC compared with SM and 2-h postdose FEV(1) for FSC compared with FP. Other efficacy measures were as follows: morning peak expiratory flow rate (PEF); transition dyspnea index; chronic respiratory disease questionnaire; chronic bronchitis symptom questionnaire; exacerbations; and other symptomatic measures. RESULTS: At Endpoint (ie, the last on-treatment, post-baseline assessment), treatment with FSC significantly (p < or = 0.012) increased the morning predose FEV(1) (165 mL) compared with SM (91 mL) and placebo (1 mL), and significantly (p < or = 0.001) increased the 2-h postdose FEV(1) (281 mL) compared with FP (147 mL) and placebo (58 mL). Improvements in lung function with FSC compared with FP and SM, and with FP and SM compared with placebo, as measured by the average daily morning PEF, was observed within approximately 24 h after the initiation of treatment, indicating an early onset of effect (p < or = 0.034). Compared with placebo, FSC significantly improved dyspnea, quality of life, and symptoms of chronic bronchitis. The incidence of adverse effects (except for an increase in oral candidiasis with FSC and FP) were similar among the treatment groups. CONCLUSIONS: Treatment with FSC (FP, 250 microg, and SM, 50 microg) twice daily substantially improved morning lung function and sustained these improvements for over a period of 24 weeks compared with FP or SM treatment alone in patients with COPD, with no additional safety concerns for the combination treatment vs that with the individual components. SN - 0012-3692 UR - https://www.unboundmedicine.com/medline/citation/12970006/The_efficacy_and_safety_of_fluticasone_propionate__250_microg_/salmeterol__50_microg__combined_in_the_Diskus_inhaler_for_the_treatment_of_COPD_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(15)37637-6 DB - PRIME DP - Unbound Medicine ER -