PMID- 9596304
OWN - NLM
STAT- MEDLINE
DCOM- 19980611
LR  - 20190514
IS  - 0012-3692 (Print)
IS  - 0012-3692 (Linking)
VI  - 113
IP  - 5
DP  - 1998 May
TI  - 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.
PG  - 1264-71
AB  - 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.
FAU - Nelson, H S
AU  - Nelson HS
AD  - Department of Medicine, National Jewish Medical and Research Center, Denver, CO 
      80206, USA.
FAU - Bernstein, I L
AU  - Bernstein IL
FAU - Fink, J
AU  - Fink J
FAU - Edwards, T B
AU  - Edwards TB
FAU - Spector, S L
AU  - Spector SL
FAU - Storms, W W
AU  - Storms WW
FAU - Tashkin, D P
AU  - Tashkin DP
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Chest
JT  - Chest
JID - 0231335
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Glucocorticoids)
RN  - 51333-22-3 (Budesonide)
RN  - KGZ1SLC28Z (Beclomethasone)
RN  - VB0R961HZT (Prednisone)
RN  - WI4X0X7BPJ (Hydrocortisone)
SB  - IM
MH  - Administration, Inhalation
MH  - Administration, Oral
MH  - Administration, Topical
MH  - Adult
MH  - Aged
MH  - Anti-Asthmatic Agents/*administration & dosage
MH  - Anti-Inflammatory Agents/*administration & dosage
MH  - Asthma/*drug therapy
MH  - Beclomethasone/administration & dosage
MH  - Budesonide/*administration & dosage
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Glucocorticoids/*administration & dosage
MH  - Humans
MH  - Hydrocortisone/blood
MH  - Male
MH  - Middle Aged
MH  - Nebulizers and Vaporizers
MH  - Prednisone/*administration & dosage
MH  - Respiratory Function Tests
EDAT- 1998/05/22 00:00
MHDA- 1998/05/22 00:01
CRDT- 1998/05/22 00:00
PHST- 1998/05/22 00:00 [pubmed]
PHST- 1998/05/22 00:01 [medline]
PHST- 1998/05/22 00:00 [entrez]
AID - S0012-3692(15)47535-X [pii]
AID - 10.1378/chest.113.5.1264 [doi]
PST - ppublish
SO  - Chest. 1998 May;113(5):1264-71. doi: 10.1378/chest.113.5.1264.