PMID- 9743163
OWN - NLM
STAT- MEDLINE
DCOM- 19981001
LR  - 20190514
IS  - 0012-3692 (Print)
IS  - 0012-3692 (Linking)
VI  - 114
IP  - 3
DP  - 1998 Sep
TI  - A comparison of triamcinolone acetonide MDI with a built-in tube extender and 
      beclomethasone dipropionate MDI in adult asthmatics.
PG  - 757-65
AB  - STUDY OBJECTIVE: In this study, the efficacy and safety of triamcinolone 
      acetonide (TA) metered-dose inhaler with a built-in tube extender and 
      beclomethasone dipropionate (BDP) metered-dose inhaler without a spacer device 
      were compared. Both treatments were dosed at their most commonly used daily doses 
      (within labeling). DESIGN: A 56-day, randomized, double-blind, double-dummy, 
      placebo-controlled trial. SETTING: Seventeen asthma/allergy centers. PATIENTS: We 
      enrolled 339 patients 18 to 65 years of age, with a documented history of 
      bronchial asthma (FEV1, 50 to 90% of predicted value) for > or = 2 years who 
      required inhaled corticosteroid therapy. INTERVENTIONS: Patients were randomized 
      to receive BDP 336 microg/d (4 puffs bid) plus TA placebo (4 puffs bid), TA 800 
      microg/d (4 puffs bid) plus BDP placebo (4 puffs bid), or TA and BDP placebos (4 
      puffs of each bid). The only other asthma medication permitted was inhaled 
      albuterol that was used as a rescue medication. All medications were administered 
      via the closed-mouth inhalation technique. MEASUREMENTS AND RESULTS: At 8 weeks 
      and at study end point, both active treatment groups had statistically 
      significant and comparable improvements in FEV1 relative to baseline, and 
      statistically significant increases relative to placebo. At study end point, 
      improvements in forced expiratory flow (FEF25.75%), clinic peak expiratory flow 
      (PEFR), and FVC were statistically significant for the active treatment groups 
      compared with placebo. At end point, the mean difference between BDP and TA for 
      mean change in FEV1 from baseline in the efficacy population was 0.02 and the 95% 
      confidence interval was -0.11, 0.15. Asthma symptoms recorded at clinic visits 
      showed statistically significant improvements for the BDP and TA groups compared 
      with the placebo group. Treatment-related adverse events occurred with similar 
      frequency in all patient groups-25.5% of placebo-treated patients, 22.3% of BDP 
      patients, and 20.4% of TA patients. The incidence of oropharyngeal adverse 
      events, including cough, thrush, and dysphonia, was not statistically different 
      between the two active treatment groups. CONCLUSION: In this randomized, 
      double-blind, placebo-controlled study of adult asthmatics treated with either 
      BDP without a spacer or TA with its built-in tube extender, BDP and TA were 
      comparable in efficacy as measured by FEV1 and other pulmonary function tests, 
      and by improvement in asthma symptoms. Both active treatments were significantly 
      more effective than placebo. All treatment groups were comparable in safety as 
      measured by the incidence of adverse events.
FAU - Berkowitz, R
AU  - Berkowitz R
AD  - Atlanta Allergy and Immunology Research Foundation, USA.
FAU - Rachelefsky, G
AU  - Rachelefsky G
FAU - Harris, A G
AU  - Harris AG
FAU - Chen, R
AU  - Chen R
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Chest
JT  - Chest
JID - 0231335
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Glucocorticoids)
RN  - F446C597KA (Triamcinolone Acetonide)
RN  - KGZ1SLC28Z (Beclomethasone)
SB  - IM
MH  - Administration, Inhalation
MH  - Administration, Topical
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Inflammatory Agents/*administration & dosage/adverse effects
MH  - Asthma/*drug therapy/physiopathology
MH  - Beclomethasone/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Forced Expiratory Volume
MH  - Glucocorticoids
MH  - Humans
MH  - Male
MH  - Maximal Midexpiratory Flow Rate
MH  - Middle Aged
MH  - *Nebulizers and Vaporizers
MH  - Peak Expiratory Flow Rate
MH  - Triamcinolone Acetonide/*administration & dosage/adverse effects
MH  - Vital Capacity
EDAT- 1998/09/22 00:00
MHDA- 1998/09/22 00:01
CRDT- 1998/09/22 00:00
PHST- 1998/09/22 00:00 [pubmed]
PHST- 1998/09/22 00:01 [medline]
PHST- 1998/09/22 00:00 [entrez]
AID - S0012-3692(16)32577-6 [pii]
AID - 10.1378/chest.114.3.757 [doi]
PST - ppublish
SO  - Chest. 1998 Sep;114(3):757-65. doi: 10.1378/chest.114.3.757.