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The safety of twice-daily treatment with fluticasone propionate and salmeterol in pediatric patients with persistent asthma.
Ann Allergy Asthma Immunol. 2005 Jul; 95(1):66-71.AA

Abstract

BACKGROUND

For children older than 5 years with asthma who remain symptomatic despite inhaled corticosteroid (ICS) therapy, the preferred treatment is to add an inhaled long-acting beta2-agonist vs increasing the ICS dose.

OBJECTIVE

To compare the safety of twice-daily treatment with inhaled fluticasone propionate plus the inhaled long-acting beta2-agonist salmeterol with that of fluticasone propionate used alone in children aged 4 to 11 years with persistent asthma.

METHODS

A randomized, multicenter, double-blind, active-controlled, parallel-group study in 203 children with persistent asthma who were symptomatic during ICS therapy. Patients received fluticasone propionate-salmeterol (100/50 microg) or fluticasone propionate (100 microg) alone twice daily for 12 weeks.

RESULTS

The safety profile of fluticasone propionate-salmeterol was similar to that of fluticasone propionate alone. The overall incidence of adverse events was 59% for fluticasone propionate-salmeterol and 57% for fluticasone propionate. Both treatments were well tolerated. Two patients receiving fluticasone propionate-salmeterol and 5 receiving fluticasone propionate withdrew from the study because of worsening asthma. Changes in heart rate, blood pressure, and laboratory variables were infrequent and were similar between treatments. No patients had clinically significant abnormal electrocardiographic findings during treatment. Geometric mean 24-hour urinary cortisol excretion at baseline and after 12 weeks of treatment was comparable within and between groups; no patient in either group had abnormally low 24-hour urinary cortisol excretion after 12 weeks of treatment. The incidence of withdrawals due to asthma exacerbations was 2% in the fluticasone propionate-salmeterol group and 5% in the fluticasone propionate group.

CONCLUSIONS

In pediatric patients with persistent asthma, fluticasone propionate-salmeterol twice daily was well tolerated, with a safety profile similar to that of fluticasone propionate used alone.

Authors+Show Affiliations

Southeast Asthma and Allergy Center, Tallahassee, Florida 32308, USA. rmalone@rose.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16095144

Citation

Malone, Randolph, et al. "The Safety of Twice-daily Treatment With Fluticasone Propionate and Salmeterol in Pediatric Patients With Persistent Asthma." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 95, no. 1, 2005, pp. 66-71.
Malone R, LaForce C, Nimmagadda S, et al. The safety of twice-daily treatment with fluticasone propionate and salmeterol in pediatric patients with persistent asthma. Ann Allergy Asthma Immunol. 2005;95(1):66-71.
Malone, R., LaForce, C., Nimmagadda, S., Schoaf, L., House, K., Ellsworth, A., & Dorinsky, P. (2005). The safety of twice-daily treatment with fluticasone propionate and salmeterol in pediatric patients with persistent asthma. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 95(1), 66-71.
Malone R, et al. The Safety of Twice-daily Treatment With Fluticasone Propionate and Salmeterol in Pediatric Patients With Persistent Asthma. Ann Allergy Asthma Immunol. 2005;95(1):66-71. PubMed PMID: 16095144.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The safety of twice-daily treatment with fluticasone propionate and salmeterol in pediatric patients with persistent asthma. AU - Malone,Randolph, AU - LaForce,Craig, AU - Nimmagadda,Sai, AU - Schoaf,Lynne, AU - House,Karen, AU - Ellsworth,Anna, AU - Dorinsky,Paul, PY - 2005/8/13/pubmed PY - 2005/9/8/medline PY - 2005/8/13/entrez SP - 66 EP - 71 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann Allergy Asthma Immunol VL - 95 IS - 1 N2 - BACKGROUND: For children older than 5 years with asthma who remain symptomatic despite inhaled corticosteroid (ICS) therapy, the preferred treatment is to add an inhaled long-acting beta2-agonist vs increasing the ICS dose. OBJECTIVE: To compare the safety of twice-daily treatment with inhaled fluticasone propionate plus the inhaled long-acting beta2-agonist salmeterol with that of fluticasone propionate used alone in children aged 4 to 11 years with persistent asthma. METHODS: A randomized, multicenter, double-blind, active-controlled, parallel-group study in 203 children with persistent asthma who were symptomatic during ICS therapy. Patients received fluticasone propionate-salmeterol (100/50 microg) or fluticasone propionate (100 microg) alone twice daily for 12 weeks. RESULTS: The safety profile of fluticasone propionate-salmeterol was similar to that of fluticasone propionate alone. The overall incidence of adverse events was 59% for fluticasone propionate-salmeterol and 57% for fluticasone propionate. Both treatments were well tolerated. Two patients receiving fluticasone propionate-salmeterol and 5 receiving fluticasone propionate withdrew from the study because of worsening asthma. Changes in heart rate, blood pressure, and laboratory variables were infrequent and were similar between treatments. No patients had clinically significant abnormal electrocardiographic findings during treatment. Geometric mean 24-hour urinary cortisol excretion at baseline and after 12 weeks of treatment was comparable within and between groups; no patient in either group had abnormally low 24-hour urinary cortisol excretion after 12 weeks of treatment. The incidence of withdrawals due to asthma exacerbations was 2% in the fluticasone propionate-salmeterol group and 5% in the fluticasone propionate group. CONCLUSIONS: In pediatric patients with persistent asthma, fluticasone propionate-salmeterol twice daily was well tolerated, with a safety profile similar to that of fluticasone propionate used alone. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/16095144/The_safety_of_twice_daily_treatment_with_fluticasone_propionate_and_salmeterol_in_pediatric_patients_with_persistent_asthma_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)61190-8 DB - PRIME DP - Unbound Medicine ER -