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Comparison of powder and aerosol formulations of salmeterol in the treatment of asthma.
Ann Allergy Asthma Immunol 2000; 84(3):334-40AA

Abstract

BACKGROUND

The efficacy and safety of the aerosol metered-dose inhaler (MDI) formulation of salmeterol for asthma symptoms have been established. Recently, salmeterol has been introduced as a micronized powder formulation administered via a breath-activated multidose powder inhaler (Diskus).

OBJECTIVE

A multicenter, randomized, double-blind, double-dummy, parallel-group, placebo-controlled study involving 498 adolescents and adults with mild-to-moderate asthma was conducted to compare the efficacy and safety of salmeterol powder 50 microg twice daily via Diskus, salmeterol aerosol 42 microg twice daily via MDI, and placebo.

METHODS

Patients were randomized to one of the three treatment groups for 12 weeks. Efficacy was assessed by serial measurements of forced expiratory volume in one second (FEV1) over 12 hours, daily peak expiratory flow (PEF), self-rated asthma symptom scores, nighttime awakenings, and supplemental albuterol use. Safety of each treatment was evaluated by monitoring vital signs, electrocardiograms, Holter monitoring, and occurrence of adverse events.

RESULTS

As compared with placebo, both salmeterol powder and aerosol produced significant improvement in FEV1 and PEF and decreased nighttime awakenings and supplemental albuterol use. There were no significant differences in the efficacy of the two salmeterol formulations. The magnitude of improvement in pulmonary function was undiminished over the 12-week study. Both formulations of salmeterol were well tolerated, with safety profiles not significantly different from placebo.

CONCLUSION

Results of this study indicate that salmeterol, administered either as a powder 50 microg twice daily via Diskus or as an aerosol 42 microg twice daily via MDI, produces clinically significant and comparable improvement in pulmonary function and is well tolerated in patients with mild-to-moderate persistent asthma.

Authors+Show Affiliations

Allergy and Asthma Associates of Santa Clara Valley Research Center, San Jose, California 95117, USA.No affiliation info availableNo 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

10752919

Citation

Wolfe, J, et al. "Comparison of Powder and Aerosol Formulations of Salmeterol in the Treatment of Asthma." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 84, no. 3, 2000, pp. 334-40.
Wolfe J, Kreitzer S, Chervinsky P, et al. Comparison of powder and aerosol formulations of salmeterol in the treatment of asthma. Ann Allergy Asthma Immunol. 2000;84(3):334-40.
Wolfe, J., Kreitzer, S., Chervinsky, P., Lawrence, M., Wang, Y., Reilly, D., ... Stahl, E. (2000). Comparison of powder and aerosol formulations of salmeterol in the treatment of asthma. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 84(3), pp. 334-40.
Wolfe J, et al. Comparison of Powder and Aerosol Formulations of Salmeterol in the Treatment of Asthma. Ann Allergy Asthma Immunol. 2000;84(3):334-40. PubMed PMID: 10752919.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of powder and aerosol formulations of salmeterol in the treatment of asthma. AU - Wolfe,J, AU - Kreitzer,S, AU - Chervinsky,P, AU - Lawrence,M, AU - Wang,Y, AU - Reilly,D, AU - Davis,S, AU - Stahl,E, PY - 2001/2/7/pubmed PY - 2001/2/7/medline PY - 2001/2/7/entrez SP - 334 EP - 40 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann. Allergy Asthma Immunol. VL - 84 IS - 3 N2 - BACKGROUND: The efficacy and safety of the aerosol metered-dose inhaler (MDI) formulation of salmeterol for asthma symptoms have been established. Recently, salmeterol has been introduced as a micronized powder formulation administered via a breath-activated multidose powder inhaler (Diskus). OBJECTIVE: A multicenter, randomized, double-blind, double-dummy, parallel-group, placebo-controlled study involving 498 adolescents and adults with mild-to-moderate asthma was conducted to compare the efficacy and safety of salmeterol powder 50 microg twice daily via Diskus, salmeterol aerosol 42 microg twice daily via MDI, and placebo. METHODS: Patients were randomized to one of the three treatment groups for 12 weeks. Efficacy was assessed by serial measurements of forced expiratory volume in one second (FEV1) over 12 hours, daily peak expiratory flow (PEF), self-rated asthma symptom scores, nighttime awakenings, and supplemental albuterol use. Safety of each treatment was evaluated by monitoring vital signs, electrocardiograms, Holter monitoring, and occurrence of adverse events. RESULTS: As compared with placebo, both salmeterol powder and aerosol produced significant improvement in FEV1 and PEF and decreased nighttime awakenings and supplemental albuterol use. There were no significant differences in the efficacy of the two salmeterol formulations. The magnitude of improvement in pulmonary function was undiminished over the 12-week study. Both formulations of salmeterol were well tolerated, with safety profiles not significantly different from placebo. CONCLUSION: Results of this study indicate that salmeterol, administered either as a powder 50 microg twice daily via Diskus or as an aerosol 42 microg twice daily via MDI, produces clinically significant and comparable improvement in pulmonary function and is well tolerated in patients with mild-to-moderate persistent asthma. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/10752919/Comparison_of_powder_and_aerosol_formulations_of_salmeterol_in_the_treatment_of_asthma_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)62783-4 DB - PRIME DP - Unbound Medicine ER -