Respiratory Medicine (1992) 86, 121-124
Inhaled steroids in patients with bronchiectasis J. S. E L B O R N * , B. JOHNSTON, F. A L L E N , J. C L A R K E , J. MCGARRY AND G. VARGHESE
Respu'atory Medicine Unit, Belfast City Hospital and Queen's UniversiO, of Belfast, Northern Ireland, U.K.
The effect of inhaled beclomethasone diproprionate (1500/tg day-)) on symptoms, pulmonary function and sputum production was examined in a double-blind, placebo-controlled, cross-over study in 20 patients with bronchiectasis. An 18% reduction in daily sputum production (P 1.5 1. Patients were then randomized to take beclomethasone diproprionate 750/tg b.d. by metered dose inhaler or matched placebo, each for 6 weeks according to a double-blind, randomized, cross-over design. Spirometry was repeated after 6 and 12 weeks in all patients, and histamine challenge tests in patients showing evidence of bronchial hyper-reactivity. During the second 3 weeks of each treatment period, daily morning (am) and evening (pm) peak expiratory flow rate (PEFR) was measured using a Wright mini peak flow meter. Daily sputum production (total expelztorated in each 24 h) was collected in a sealed © 1992 Baillirre Tindall
122
J. S. Elborn et al. Table 1 Pulmonary function, sputum production and visual analogue scores on placebo and beclomethasone dipropionate (BDP) 750 pg b.d. Results are expressed as the mean and 95% confidence interval. (Abbreviations as per text.)
Placebo
BDP
P value
FEV 1(1)
2-2 (I .2-4.4)
2-31 (I .2--4.8)
0-03
FVC (l)
3.17 (1.7-5.8)
3.15 (I-7-5.9)
0.15
27.3 (9-95)
22.3 (0-68)
0.003
PEFR am (I min ~)
354 (148-596)
369 (167-631)
0.03
PEFR pm (1 min -I)
370 (218-597)
382 (232~34)
0.22
Cough (mm)
43 (17~58)
48 (22-72)
0-02
Wheeze (mm)
49 (29-72)
51 (35-72)
0.09
Dyspnoea (ram)
43 (18-72)
47 (29-72)
0-10
Sputum production (g)
airtight container and a visual analogue score for cough, wheeze and dyspnoea recorded in a diary on a 75-mm line. Sputum was collected weekly from patients and the wet sputum weighed in the pot on an electronic balance. The sputum pots were pre-weighed and this value was subtracted from total to give the final sputum weight. F o r each treatment period mean daily (am and pm) PEFR, sputum production and visual analogue scores were calculated from the complete 3-week data. These mean values for each parameter were not normally distributed, so statistical comparisons between active drug and placebo were made using Wilcoxon's test and the results expressed as a mean and 95% confidence interval.
beclomethasone treatment compared to placebo. Forced expiratory volume in l s was significantly higher on beclomethasone compared to placebo (Table 1). No significant difference was demonstrated in forced vital capacity. Mean daily sputum production was significantly less on inhaled steroid compared to placebo (Table l, Fig. 1). Small, though significant improvements in am P E F R and visual analogue scores for cough were observed on steroid treatment compared to placebo (Table l). No significant difference was noted between placebo and inhaled steroid treatment for pm P E F R or visual analogue scores for wheeze or shortness of breath, Few side effects were noted during the study apart from one patient who developed oral candidiasis during inhaled steroid treatment.
Results Discussion Five patients were withdrawn during the study, three due to infection (two during beclomethasone treatment and one during placebo) and two others declined to take part in the second limb of the study. Histamine challenge tests were performed on 18 patients and demonstrated bronchial hyper-reactivity in three, [ > 2 0 % fall in FEV, at a cumulative dose (PD20) of
Inhaled steroids in patients with bronchiectasis J. S. E L B O R N * , B. JOHNSTON, F. A L L E N , J. C L A R K E , J. MCGARRY AND G. VARGHESE
Respu'atory Medicine Unit, Belfast City Hospital and Queen's UniversiO, of Belfast, Northern Ireland, U.K.
The effect of inhaled beclomethasone diproprionate (1500/tg day-)) on symptoms, pulmonary function and sputum production was examined in a double-blind, placebo-controlled, cross-over study in 20 patients with bronchiectasis. An 18% reduction in daily sputum production (P 1.5 1. Patients were then randomized to take beclomethasone diproprionate 750/tg b.d. by metered dose inhaler or matched placebo, each for 6 weeks according to a double-blind, randomized, cross-over design. Spirometry was repeated after 6 and 12 weeks in all patients, and histamine challenge tests in patients showing evidence of bronchial hyper-reactivity. During the second 3 weeks of each treatment period, daily morning (am) and evening (pm) peak expiratory flow rate (PEFR) was measured using a Wright mini peak flow meter. Daily sputum production (total expelztorated in each 24 h) was collected in a sealed © 1992 Baillirre Tindall
122
J. S. Elborn et al. Table 1 Pulmonary function, sputum production and visual analogue scores on placebo and beclomethasone dipropionate (BDP) 750 pg b.d. Results are expressed as the mean and 95% confidence interval. (Abbreviations as per text.)
Placebo
BDP
P value
FEV 1(1)
2-2 (I .2-4.4)
2-31 (I .2--4.8)
0-03
FVC (l)
3.17 (1.7-5.8)
3.15 (I-7-5.9)
0.15
27.3 (9-95)
22.3 (0-68)
0.003
PEFR am (I min ~)
354 (148-596)
369 (167-631)
0.03
PEFR pm (1 min -I)
370 (218-597)
382 (232~34)
0.22
Cough (mm)
43 (17~58)
48 (22-72)
0-02
Wheeze (mm)
49 (29-72)
51 (35-72)
0.09
Dyspnoea (ram)
43 (18-72)
47 (29-72)
0-10
Sputum production (g)
airtight container and a visual analogue score for cough, wheeze and dyspnoea recorded in a diary on a 75-mm line. Sputum was collected weekly from patients and the wet sputum weighed in the pot on an electronic balance. The sputum pots were pre-weighed and this value was subtracted from total to give the final sputum weight. F o r each treatment period mean daily (am and pm) PEFR, sputum production and visual analogue scores were calculated from the complete 3-week data. These mean values for each parameter were not normally distributed, so statistical comparisons between active drug and placebo were made using Wilcoxon's test and the results expressed as a mean and 95% confidence interval.
beclomethasone treatment compared to placebo. Forced expiratory volume in l s was significantly higher on beclomethasone compared to placebo (Table 1). No significant difference was demonstrated in forced vital capacity. Mean daily sputum production was significantly less on inhaled steroid compared to placebo (Table l, Fig. 1). Small, though significant improvements in am P E F R and visual analogue scores for cough were observed on steroid treatment compared to placebo (Table l). No significant difference was noted between placebo and inhaled steroid treatment for pm P E F R or visual analogue scores for wheeze or shortness of breath, Few side effects were noted during the study apart from one patient who developed oral candidiasis during inhaled steroid treatment.
Results Discussion Five patients were withdrawn during the study, three due to infection (two during beclomethasone treatment and one during placebo) and two others declined to take part in the second limb of the study. Histamine challenge tests were performed on 18 patients and demonstrated bronchial hyper-reactivity in three, [ > 2 0 % fall in FEV, at a cumulative dose (PD20) of
