PMID- 12418585
OWN - NLM
STAT- MEDLINE
DCOM- 20021226
LR  - 20190906
IS  - 0954-6111 (Print)
IS  - 0954-6111 (Linking)
VI  - 96
IP  - 11
DP  - 2002 Nov
TI  - Efficacy and safety of oxitropium bromide, theophylline and their combination in 
      COPD patients: a double-blind, randomized, multicentre study (BREATH Trial).
PG  - 881-9
AB  - We compare the efficacy including spirometry, peak expiratory flow (PEFR) and 
      quality of life and safety of an 8-week treatment with inhaled oxitropium, 
      theophylline or their combination in patients with mild-to-severe chronic 
      obstructive pulmonary disease (COPD). We conducted a multicentre, double-blind, 
      double-dummy randomized, parallel-group study at 29 Italian outpatients clinics. 
      A group of 236 patients with mild-to-severe COPD (baseline FEV1 < or = 70% of 
      predicted value) were recruited. Treatments were as follows: Inhaled oxitropium 
      bromide 200 microg (N=75), sustained-release oral theophylline 300 mg (N=81) or 
      their combination (N=80), taken twice daily. Spirometry (FEV1 and FVC) was 
      evaluated every 4 weeks, and morning and evening PEFR (before and 2-4 h after 
      drug intake) was measured daily. Symptoms, cough and dysponea, were recorded 
      daily. Health status was evaluated at baseline and week 8 using the disease 
      specific St George' Respiratory Questionnaire (SGRQ). Any adverse event occurring 
      during the treatment period was recorded on a diary card. FEV1 and FVC improved 
      in all the groups at 4 and 8 weeks, but the difference between treatment groups 
      did not reach statistically significant levels. Differences between groups in 
      pre-dosing morning and evening PEFR were not significant. Post-dosing morning and 
      evening PEFR were increased and the largest increase was seen in patients treated 
      with both drugs. However, differences between groups was significant only for 
      evening values (P=0.008). The proportion of patients who experienced a decrease 
      in symptoms was high in all groups but no differences among groups were observed. 
      SGRQ total scores decreased in all treatment groups after 8 weeks, particularly 
      in the oxitropium and combination groups. Clinically significant change (> or = 4 
      units) was only observed in patients treated with oxitropium bromide whether with 
      or without theophylline. Adverse events related to treatments were higher in the 
      group treated with theophylline alone (P < 0.02). We conclude that inhaled 
      oxitropium bromide alone was associated with an improvement in FEV1, PEFR and 
      symptoms in patients with COPD that was not statistically different from that of 
      oral theophylline alone or of the combination of both drugs. Oxitropium bromide 
      in combination with theophylline provided a greater improvement in evening 
      post-dosing PEFR. Oxitropium bromide alone or in combination with theophylline 
      improved the quality of life better than theophylline alone.
FAU - Bellia, V
AU  - Bellia V
AD  - Istituto Clinica delle Malattie Apparato Respiration, Palermo, Italy.
FAU - Foresi, A
AU  - Foresi A
FAU - Bianco, S
AU  - Bianco S
FAU - Grassi, V
AU  - Grassi V
FAU - Olivieri, D
AU  - Olivieri D
FAU - Bensi, G
AU  - Bensi G
FAU - Volonte, M
AU  - Volonte M
CN  - BREATH Italian Study Group
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Parasympatholytics)
RN  - 0 (Scopolamine Derivatives)
RN  - 8G15T83E6I (oxitropium)
RN  - C137DTR5RG (Theophylline)
SB  - IM
MH  - Aged
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Lung Diseases, Obstructive/*drug therapy/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Parasympatholytics/*therapeutic use
MH  - Peak Expiratory Flow Rate
MH  - Quality of Life
MH  - Scopolamine Derivatives/*therapeutic use
MH  - Spirometry
MH  - Theophylline/*therapeutic use
EDAT- 2002/11/07 04:00
MHDA- 2002/12/27 04:00
CRDT- 2002/11/07 04:00
PHST- 2002/11/07 04:00 [pubmed]
PHST- 2002/12/27 04:00 [medline]
PHST- 2002/11/07 04:00 [entrez]
AID - S0954-6111(02)91380-6 [pii]
AID - 10.1053/rmed.2002.1380 [doi]
PST - ppublish
SO  - Respir Med. 2002 Nov;96(11):881-9. doi: 10.1053/rmed.2002.1380.