Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of fluticasone propionate 44 microg/salmeterol 21 microg administered in a hydrofluoroalkane metered-dose inhaler as an initial asthma maintenance treatment.
Ann Allergy Asthma Immunol. 2003 Sep; 91(3):263-9.AA

Abstract

BACKGROUND

We wanted to evaluate whether treatment with an inhaled corticosteroid and an inhaled long-acting beta2-agonist is more effective than an inhaled corticosteroid alone for patients using as-needed albuterol who are initiating maintenance treatment.

OBJECTIVE

To compare the efficacy and safety of twice-daily fluticasone propionate (FP) 88 microg and salmeterol 42 microg combined in a chlorofluorocarbon (CFC)-free (hydrofluoroalkane 134a) metered-dose inhaler (MDI) with the individual agents alone, each delivered through an MDI containing CFC propellants, in patient with persistent asthma previously uncontrolled with as-needed short-acting beta2-agonists alone.

METHODS

Patients with asthma (n = 283) were randomized to twice-daily treatment for 12 weeks with FP 88 microg combined with salmeterol 42 microg (FSC) in a CFC-free MDI or the individual components alone from CFC-containing MDIs.

RESULTS

At endpoint, mean change from baseline in morning predose forced expiratory volume in 1 second was significantly (P < or = 0.016) greater with FSC (0.69 L) compared with FP (0.51 L) or salmeterol (0.47 L). Fewer patients treated with FSC withdrew due to worsening asthma (1%) compared with FP (3%) or salmeterol (8%; P = 0.024). FSC significantly increased (P < or = 0.002) morning and evening peak expiratory flow rate at endpoint (66.5 and 51.5 L/min, respectively) compared with FP (43.0 and 29.9 L/min, respectively) and salmeterol (29.2 and 21.6 L/min, respectively). In addition, asthma symptom scores were reduced, and percentages of days with no asthma symptoms increased in all treatment groups.

CONCLUSIONS

Treatment with FSC in a CFC-free MDI is more effective than FP or salmeterol alone in asthma patients who are symptomatic taking short-acting beta2-agonists alone.

Authors+Show Affiliations

National Jewish Medical and Research Center, Denver, Colorado 80206, USA. nelsonh@njc.orgNo 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
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14533658

Citation

Nelson, Harold S., et al. "Efficacy and Safety of Fluticasone Propionate 44 Microg/salmeterol 21 Microg Administered in a Hydrofluoroalkane Metered-dose Inhaler as an Initial Asthma Maintenance Treatment." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 91, no. 3, 2003, pp. 263-9.
Nelson HS, Wolfe JD, Gross G, et al. Efficacy and safety of fluticasone propionate 44 microg/salmeterol 21 microg administered in a hydrofluoroalkane metered-dose inhaler as an initial asthma maintenance treatment. Ann Allergy Asthma Immunol. 2003;91(3):263-9.
Nelson, H. S., Wolfe, J. D., Gross, G., Greos, L. S., Baitinger, L., Scott, C., & Dorinsky, P. (2003). Efficacy and safety of fluticasone propionate 44 microg/salmeterol 21 microg administered in a hydrofluoroalkane metered-dose inhaler as an initial asthma maintenance treatment. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 91(3), 263-9.
Nelson HS, et al. Efficacy and Safety of Fluticasone Propionate 44 Microg/salmeterol 21 Microg Administered in a Hydrofluoroalkane Metered-dose Inhaler as an Initial Asthma Maintenance Treatment. Ann Allergy Asthma Immunol. 2003;91(3):263-9. PubMed PMID: 14533658.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of fluticasone propionate 44 microg/salmeterol 21 microg administered in a hydrofluoroalkane metered-dose inhaler as an initial asthma maintenance treatment. AU - Nelson,Harold S, AU - Wolfe,James D, AU - Gross,Gary, AU - Greos,Leon S, AU - Baitinger,Leslie, AU - Scott,Catherine, AU - Dorinsky,Paul, PY - 2003/10/10/pubmed PY - 2003/11/13/medline PY - 2003/10/10/entrez SP - 263 EP - 9 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann Allergy Asthma Immunol VL - 91 IS - 3 N2 - BACKGROUND: We wanted to evaluate whether treatment with an inhaled corticosteroid and an inhaled long-acting beta2-agonist is more effective than an inhaled corticosteroid alone for patients using as-needed albuterol who are initiating maintenance treatment. OBJECTIVE: To compare the efficacy and safety of twice-daily fluticasone propionate (FP) 88 microg and salmeterol 42 microg combined in a chlorofluorocarbon (CFC)-free (hydrofluoroalkane 134a) metered-dose inhaler (MDI) with the individual agents alone, each delivered through an MDI containing CFC propellants, in patient with persistent asthma previously uncontrolled with as-needed short-acting beta2-agonists alone. METHODS: Patients with asthma (n = 283) were randomized to twice-daily treatment for 12 weeks with FP 88 microg combined with salmeterol 42 microg (FSC) in a CFC-free MDI or the individual components alone from CFC-containing MDIs. RESULTS: At endpoint, mean change from baseline in morning predose forced expiratory volume in 1 second was significantly (P < or = 0.016) greater with FSC (0.69 L) compared with FP (0.51 L) or salmeterol (0.47 L). Fewer patients treated with FSC withdrew due to worsening asthma (1%) compared with FP (3%) or salmeterol (8%; P = 0.024). FSC significantly increased (P < or = 0.002) morning and evening peak expiratory flow rate at endpoint (66.5 and 51.5 L/min, respectively) compared with FP (43.0 and 29.9 L/min, respectively) and salmeterol (29.2 and 21.6 L/min, respectively). In addition, asthma symptom scores were reduced, and percentages of days with no asthma symptoms increased in all treatment groups. CONCLUSIONS: Treatment with FSC in a CFC-free MDI is more effective than FP or salmeterol alone in asthma patients who are symptomatic taking short-acting beta2-agonists alone. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/14533658/Efficacy_and_safety_of_fluticasone_propionate_44_microg/salmeterol_21_microg_administered_in_a_hydrofluoroalkane_metered_dose_inhaler_as_an_initial_asthma_maintenance_treatment_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=14533658.ui DB - PRIME DP - Unbound Medicine ER -