Comparison of adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler and fixed-dose fluticasone propionate/salmeterol dry powder inhaler in asthma patients.

Abstract

BACKGROUND:

The adjustable-dose budesonide/formoterol dry powder inhaler (DPI) has demonstrated similar or greater asthma control with less inhaled corticosteroid compared with the fixed-dose budesonide/formoterol DPI.

OBJECTIVE:

We sought to evaluate the efficacy, tolerability, and resource use of maintenance therapy with the adjustable-dose budesonide/formoterol pressurized metered-dose inhaler versus the fixed-dose budesonide/formoterol pressurized metered-dose inhaler and the fixed-dose fluticasone propionate/salmeterol DPI.

METHODS:

This was a randomized, open-label, multicenter study of patients (N = 1225) 12 years and older with moderate-to-severe persistent asthma. After 10 to 14 days of current therapy, patients were randomized 2:1 to fixed-dose budesonide/formoterol (160/4.5 microg x 2 inhalations [320/9 microg] twice daily) or fixed-dose fluticasone propionate/salmeterol (250/50 microg x 1 inhalation twice daily) for 1 month (treatment period 1), after which, the fixed-dose fluticasone propionate/salmeterol group continued therapy and the fixed-dose budesonide/formoterol group was randomized 1:1 to fixed-dose budesonide/formoterol or adjustable-dose budesonide/formoterol (adjustable from 2 inhalations [320/9 microg] twice daily to 2 inhalations [320/9 microg] once daily or 4 inhalations [640/18 microg] twice daily) for 6 months (treatment period 2).

RESULTS:

There were no significant between-group differences in asthma exacerbations (primary variable), asthma symptoms, or lung function during the 7-month treatment period. Less study drug (inhalations per day, P < .001) was used with adjustable-dose versus fixed-dose budesonide/formoterol. All treatments were well tolerated.

CONCLUSIONS:

Adjustable-dose and fixed-dose budesonide/formoterol showed no differences in asthma control or tolerability versus fixed-dose fluticasone propionate/salmeterol.

• Authors: William W Busse, Shailen R Shah, Laura Somerville, Bhash Parasuraman, Paula Martin, Mitchell Goldman
• Journal: The Journal of allergy and clinical immunology (J Allergy Clin Immunol) Vol. 121 Issue 6 Pg. 1407-14, 1414.e1-6 (Jun 2008) ISSN: 1097-6825 [Electronic] United States
• PMID: 18455221 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Androstadienes
• Bronchodilator Agents
• Drug Combinations
• Ethanolamines
• Fluticasone-Salmeterol Drug Combination
• Budesonide
• Albuterol
• Formoterol Fumarate

Topics

• Adolescent
• Adult
• Aged
• Albuterol (administration & dosage, analogs & derivatives)
• Androstadienes (administration & dosage)
• Asthma (drug therapy)
• Bronchodilator Agents (administration & dosage)
• Budesonide (administration & dosage)
• Child
• Drug Combinations
• Ethanolamines (administration & dosage)
• Female
• Fluticasone-Salmeterol Drug Combination
• Formoterol Fumarate
• Humans
• Male
• Metered Dose Inhalers
• Middle Aged
• Respiratory Function Tests