Comparison of Patient-Reported Outcomes During Treatment with Adjustable- and Fixed-Dose Budesonide/Formoterol Pressurized Metered-Dose Inhaler Versus Fixed-Dose Fluticasone Propionate/Salmeterol Dry Powder Inhaler in Patients with Asthma

Details

• Personal Author:
  Goldman M ; Martin P ; O'Connor RD ; Parasuraman B ; Patrick DL
• Description:
  Objective. Assessment of patient-reported outcomes is important in evaluating the impact of asthma treatment. This study was conducted to compare effects of adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler with fixed-dose fluticasone propionate/salmeterol dry powder inhaler regimens on patient-reported outcomes in patients aged >/=18 years with moderate to severe asthma. Methods. In this phase III, randomized, open-label study, 1225 patients were randomized 2:1 to fixed-dose budesonide/formoterol 160/4.5 ug × 2 inhalations (320/9 ug) twice daily or fixed-dose fluticasone propionate/salmeterol 250/50 ug twice daily for 1 month. In the subsequent 6 months, patients receiving fixed-dose fluticasone propionate/salmeterol continued therapy, whereas those receiving fixed-dose budesonide/formoterol were randomized 1:1 to fixed-dose or adjustable-dose budesonide/formoterol (adjustable from 320/9 ug twice daily to 320/9 ug once daily or 640/18 ug twice daily). Results. Mean improvements from baseline to end of treatment in the Asthma Quality of Life Questionnaire (standardized) overall and individual domain scores and the Asthma Control Questionnaire score were clinically important (>/=0.5 points) for all treatments. Patients in both budesonide/formoterol groups reported greater treatment satisfaction on the Asthma Treatment Satisfaction Measure questionnaire than patients in the fluticasone propionate/salmeterol dry powder inhaler group for the attributes of timely relief of symptoms (p ≤ .037) and feel medication working (p ≤ .020). Onset of Effect Questionnaire scores showed a greater percentage of patients perceiving onset of effect with budesonide/formoterol regimens versus fixed-dose fluticasone propionate/salmeterol (p ≤ .002). Conclusions. Treatment regimens did not differ regarding improvements in asthma-specific quality of life and asthma control. Questions related to perceived rate of onset and feeling medication working in the Asthma Treatment Satisfaction Measure and Onset of Effect Questionnaire generally elicited somewhat more favorable responses with budesonide/formoterol pressurized metered-dose inhaler regimens versus fixed-dose fluticasone propionate/salmeterol dry powder inhaler. [Description provided by NIOSH]
• Subjects:
  Asthma Asthma, Occupational Drug Therapy Occupational Health Safety
• Keywords:
  Author Keywords: Budesonide Drug Therapy Fluticasone Formoterol Medical Treatment Patient-reported Outcomes Quality Of Life Salmeterol
• ISSN:
  0277-0903
• Document Type:
  Text
• Funding:
  Grant
• Genre:
  Journal Article
• Place as Subject:
  California ; Delaware ; OSHA Region 10 ; OSHA Region 3 ; OSHA Region 9 ; Washington
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Pages in Document:
  217-223
• Volume:
  47
• Issue:
  2
• NIOSHTIC Number:
  nn:20057034
• Citation:
  J Asthma 2010 Mar; 47(2):217-223
• Contact Point Address:
  Richard D. O'Connor, M.D., Sharp Rees-Stealy Medical Group, 2001 Fourth Avenue, San Diego, CA 92101, USA
• Email:
  richard.oconnor@sharp.com
• Federal Fiscal Year:
  2010
• Performing Organization:
  University of Washington
• Peer Reviewed:
  True
• Start Date:
  20050701
• Source Full Name:
  Journal of Asthma
• End Date:
  20250630
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:43461f3bfc863a7cd3208a3cee924f814546f11d4f9fd041751279a33c7cc06fb009110f506bcd92e0d9761957b1b3db6464231785ba4412268bfc805797c91a
• Download URL:
  https://stacks.cdc.gov/view/cdc/214510/cdc_214510_DS1.pdf
• File Type:
  [PDF - 527.50 KB ]