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Fluticasone propionate hydrofluoroalkane inhalation aerosol in patients receiving inhaled corticosteroids.
Ann Allergy Asthma Immunol. 2006 Jan; 96(1):51-9.AA

Abstract

BACKGROUND

Inhaled corticosteroids (ICSs) delivered by metered-dose inhalers that contain chlorofluorocarbon propellants are being discontinued because of the harmful effects of chlorofluorocarbon on the ozone layer. Therefore, some metered-dose inhaler products are being reformulated with "ozone-friendly" hydrofluoroalkane propellants.

OBJECTIVE

To evaluate treatment with fluticasone propionate hydrofluoroalkane inhalation aerosol, 88, 220, and 440 microg twice daily, vs placebo in patients with asthma receiving an ICS.

METHODS

Randomized, double-blind, parallel-group, 12-week study.

RESULTS

Mean morning predose percent predicted forced expiratory volume in 1 second increased by 2.2%, 3.2%, and 4.6% in the fluticasone propionate, 88-, 220-, and 440-microg twice-daily, groups, respectively, compared with an 8.3% decrease for placebo (P < .001 vs placebo for all groups). Secondary pulmonary function end points and asthma symptoms showed similar improvements compared with placebo. Discontinuation from the study due to lack of efficacy was 50% in the placebo group and 11%, 10%, and 6% in the fluticasone propionate, 88-, 220-, and 440-microg twice-daily, groups, respectively. At week 12, the probability of remaining in the study was 0.89, 0.90, and 0.94 for the fluticasone propionate, 88-, 220-, and 440-microg twice-daily, groups, respectively, vs 0.45 for the placebo group (P < .001 for all). Changes in 24-hour urinary cortisol excretion rates were similar among treatment groups.

CONCLUSIONS

Fluticasone propionate hydrofluoroalkane, previously shown to be a clinically suitable alternative to fluticasone propionate chlorofluorocarbon, was effective and well tolerated. The ability to switch from fluticasone propionate chlorofluorocarbon and other chlorofluorocarbon-containing ICSs to fluticasone propionate hydrofluoroalkane without sacrificing asthma control or tolerability will facilitate a smooth transition to this nonchlorofluorocarbon-containing medicinal.

Authors+Show Affiliations

AARA Research Center, Dallas, TX 75231, USA. lumrymd@sbcglobal.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16440533

Citation

Lumry, William R., et al. "Fluticasone Propionate Hydrofluoroalkane Inhalation Aerosol in Patients Receiving Inhaled Corticosteroids." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 96, no. 1, 2006, pp. 51-9.
Lumry WR, Conway MM, LaForce CF, et al. Fluticasone propionate hydrofluoroalkane inhalation aerosol in patients receiving inhaled corticosteroids. Ann Allergy Asthma Immunol. 2006;96(1):51-9.
Lumry, W. R., Conway, M. M., LaForce, C. F., Pearlman, D. S., Scott, C. A., Herje, N. E., Wu, W. W., & Crim, C. (2006). Fluticasone propionate hydrofluoroalkane inhalation aerosol in patients receiving inhaled corticosteroids. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 96(1), 51-9.
Lumry WR, et al. Fluticasone Propionate Hydrofluoroalkane Inhalation Aerosol in Patients Receiving Inhaled Corticosteroids. Ann Allergy Asthma Immunol. 2006;96(1):51-9. PubMed PMID: 16440533.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fluticasone propionate hydrofluoroalkane inhalation aerosol in patients receiving inhaled corticosteroids. AU - Lumry,William R, AU - Conway,Michael M, AU - LaForce,Craig F, AU - Pearlman,David S, AU - Scott,Catherine A, AU - Herje,Nancy E, AU - Wu,Wei W, AU - Crim,Courtney, PY - 2006/1/31/pubmed PY - 2006/2/16/medline PY - 2006/1/31/entrez SP - 51 EP - 9 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann Allergy Asthma Immunol VL - 96 IS - 1 N2 - BACKGROUND: Inhaled corticosteroids (ICSs) delivered by metered-dose inhalers that contain chlorofluorocarbon propellants are being discontinued because of the harmful effects of chlorofluorocarbon on the ozone layer. Therefore, some metered-dose inhaler products are being reformulated with "ozone-friendly" hydrofluoroalkane propellants. OBJECTIVE: To evaluate treatment with fluticasone propionate hydrofluoroalkane inhalation aerosol, 88, 220, and 440 microg twice daily, vs placebo in patients with asthma receiving an ICS. METHODS: Randomized, double-blind, parallel-group, 12-week study. RESULTS: Mean morning predose percent predicted forced expiratory volume in 1 second increased by 2.2%, 3.2%, and 4.6% in the fluticasone propionate, 88-, 220-, and 440-microg twice-daily, groups, respectively, compared with an 8.3% decrease for placebo (P < .001 vs placebo for all groups). Secondary pulmonary function end points and asthma symptoms showed similar improvements compared with placebo. Discontinuation from the study due to lack of efficacy was 50% in the placebo group and 11%, 10%, and 6% in the fluticasone propionate, 88-, 220-, and 440-microg twice-daily, groups, respectively. At week 12, the probability of remaining in the study was 0.89, 0.90, and 0.94 for the fluticasone propionate, 88-, 220-, and 440-microg twice-daily, groups, respectively, vs 0.45 for the placebo group (P < .001 for all). Changes in 24-hour urinary cortisol excretion rates were similar among treatment groups. CONCLUSIONS: Fluticasone propionate hydrofluoroalkane, previously shown to be a clinically suitable alternative to fluticasone propionate chlorofluorocarbon, was effective and well tolerated. The ability to switch from fluticasone propionate chlorofluorocarbon and other chlorofluorocarbon-containing ICSs to fluticasone propionate hydrofluoroalkane without sacrificing asthma control or tolerability will facilitate a smooth transition to this nonchlorofluorocarbon-containing medicinal. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/16440533/Fluticasone_propionate_hydrofluoroalkane_inhalation_aerosol_in_patients_receiving_inhaled_corticosteroids_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)61040-X DB - PRIME DP - Unbound Medicine ER -