Document Detail


Oral glucocorticosteroid-sparing effect of budesonide administered by Turbuhaler: a double-blind, placebo-controlled study in adults with moderate-to-severe chronic asthma. Pulmicort Turbuhaler Study Group.
MedLine Citation:
PMID:  9596304     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To determine the ability of budesonide via an inhaler (Pulmicort Turbuhaler; Astra Draco AB) to replace oral glucocorticosteroids (GCSs) in adult subjects with moderate-to-severe asthma. DESIGN: Double-blind, randomized, and placebo-controlled study, with parallel groups. SETTING: Multicenter study in outpatient setting. PARTICIPANTS: Eighty men and 79 women, aged 20 to 69 years, with moderate-to-severe asthma and a mean FEV1 of 58.3% predicted normal. All subjects were receiving oral GCS treatment and 79% of subjects were also receiving inhaled beclomethasone dipropionate (BDP). The mean daily doses of prednisone at baseline, including converted dose of BDP, for the placebo, budesonide 400 microg, and budesonide 800 microg, respectively, were 19.7 mg, 19.5 mg, and 18.7 mg. MEASUREMENTS AND INTERVENTIONS: After a 2-week baseline period, subjects entered a 20-week treatment period, during which the oral dose of prednisone was reduced by forced down-titration at 2-weekly intervals. RESULTS: Subjects receiving 400 microg or 800 microg bid of budesonide achieved a significantly greater reduction (82.9% and 79.0% respectively) in oral GCS dose compared with placebo-treated subjects (27%; p<0.001). Two thirds of the subjects receiving budesonide were able to achieve sustained oral corticosteroid cessation, compared with 8% in the placebo group. Additionally, both doses of budesonide resulted in significant improvement in results of pulmonary function tests and asthma symptoms scores, and a significant decrease in the use of bronchodilator therapy. The mean plasma cortisol levels before and after adrenocorticotropic hormone stimulation increased most toward the normal range in the budesonide-treated groups compared with placebo-treated subjects. CONCLUSION: Budesonide administered via Turbuhaler has a significant oral GCS-sparing capacity with maintained or improved asthma control in adult subjects with moderate-to-severe asthma.
Authors:
H S Nelson; I L Bernstein; J Fink; T B Edwards; S L Spector; W W Storms; D P Tashkin
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Chest     Volume:  113     ISSN:  0012-3692     ISO Abbreviation:  Chest     Publication Date:  1998 May 
Date Detail:
Created Date:  1998-06-11     Completed Date:  1998-06-11     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0231335     Medline TA:  Chest     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1264-71     Citation Subset:  AIM; IM    
Affiliation:
Department of Medicine, National Jewish Medical and Research Center, Denver, CO 80206, USA.
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MeSH Terms
Descriptor/Qualifier:
Administration, Inhalation
Administration, Oral
Administration, Topical
Adult
Aged
Anti-Asthmatic Agents / administration & dosage*
Anti-Inflammatory Agents / administration & dosage*
Asthma / drug therapy*
Beclomethasone / administration & dosage
Budesonide / administration & dosage*
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
Glucocorticoids / administration & dosage*
Humans
Hydrocortisone / blood
Male
Middle Aged
Nebulizers and Vaporizers
Prednisone / administration & dosage*
Respiratory Function Tests
Chemical
Reg. No./Substance:
0/Anti-Asthmatic Agents; 0/Anti-Inflammatory Agents; 0/Glucocorticoids; 4419-39-0/Beclomethasone; 50-23-7/Hydrocortisone; 51333-22-3/Budesonide; 53-03-2/Prednisone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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