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Nonasthmatic chronic cough: RESULTS (3)

Effect of treatment on cough: Cough discomfort before and after two weeks of treatment with placebo or budesonide was examined. The severity of cough discomfort before treatment did not differ between the treatment groups (Table 1) nor between patients with or without sputum neutrophilia (Table 2). The effects of two weeks treatment with budesonide on cough discomfort, as measured by the VAS, was similar to the placebo effect whether analyzed as the difference between actual values or as the difference between the percentage reduction in cough discomfort (Figure 3). The reduction in cough discomfort after two weeks treatment with open label budesonide was also similar in the two groups. A reduction of 50% or greater in cough discomfort (from baseline) after two weeks of blind budesonide or placebo occurred in only four patients of the budesonide group. In contrast, the two weeks of open treatment with budesonide produced a reduction of 50% or greater in cough discomfort (from baseline) in eight patients of the budesonide and in nine of the placebo group (Figure 3). Effect of treatment on airway inflammation: The effect of treatment on airway inflammation was examined only in the 23 patients who produced sputum on each visit (Table 3). Treatment with budesonide for two or four weeks did not have a significant effect in any of the sputum inflammatory markers. Local side effects: Four (three budesonide, one placebo) and 11 (five budesonide and six placebo) patients reported mild local side effects after two or four weeks of treatment, respectively. The side effects included hoarseness (six patients), sore throat (five patients), hoarseness and sore throat (two patients), and dry mouth (two patients). The only finding observed on inspection was redness of oropharyngeal mucosa. No patient had to discontinue treatment because of the local effects.

Table 1. Subject characteristics in a study of patients with nonasthmatic chronic cough

Characteristic Placebo (n=23) Budesonide (n=21)
Age (years)* 47 43
Sex, male 10 6
Smoking (non [ex]) 17 15
Atopic (n) 9 8
FEV1 (L) 3.5 (3.0,3.6) 3.6 (3.9,4.0)
FEV1 (% predicted) 102 101
FEV1/VC (%) 80 82
AFEV-i after 2.5 (1.2,3.8) 3.5 (1.2,5.1)
bronchodilator
(% from predicted)
PC20 methacholine >8.0 >8.0
(mg/mL)
Previous cough 14 14
investigation (n)
Previous cough 14 12
treatment (n)
Previous inhaled 4 3
steroid trial (n)
Cough duration (years) 11.8 (4.6,19.2) 9.8 (5.3,14.2)
Cough questionnaire score’1 5.2 (4.6,5.9) 4.6 (3.7,5.5)
Cough VAS (mm)* 51.0 61.4

Data are expressed as mean (95% CI) or otherwise as specified. Atopic means one or more positive allergy skin prick tests. Forced expiratory volume in 1 s (FEVi) predicted values from Crapo etal or previous best in the past two years. *Mean (minimum-maximum); fA 9-point Likert scale (see text); *A 100 mm horizontal visual analogue scale (see text). PC20 Provocation concentration of methacholine to cause a fall in FEV1 of 20%; VAS Visual analogue scale; VC Vital capacity

Table 3. Sputum inflammatory indexes before and after treatment with placebo or budesonide

VAS*(mm) TTC(x106/mL) E (%) N (%) M (%) L (%) C)E%B( ECP(Pg/mL) Fibrinogen(pg/mL) IL-8(pg/mL) Subs P (pg/mL)
Placebo group (n=12)
Baseline 52 3.8 (7.7) 0 (0.2) 45 47 0.2 (0.8) 0 (0.3) 312 3910 6480 936
Placebo 48 3.5 (2.1) 0 (0.3) 53 42 0.3 (1.2) 0 320 7120 10,600 636
Open label budesonide Budesonide 36 ** group (n=11) 4.2 (3.3) 0 (0.3) 38 59 0.3 (0.3) 0 (0.3) 320 4560 8200 520
Baseline 59 2.9 (4.8) 0 (0.3) 36 63 0.5 (1.0) 0 (0.5) 264 3680 4280 904
Budesonide 52 2.8 (1.4) 0 (0.3) 38 59 0.3 (0.2) 0 232 4960 8560 434
Open label budesonide 27 ** 2.2 (3.4) 0 35 65 0.2 (0.8) 0 (0.5) 128 3440 4840 564

*Median values including all patients in each group; **P

Figure 3. Nonasthmatic chronic cough
Figure 3) Effects of treatment on cough discomfort. The effect of budesonide treatment (closed circles) on cough discomfort was similar to placebo treatment (open circles). Continuous line represents no effect. Dashed line represents a 50% reductionfrom baseline in cough discomfort

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