title: [The effect of fenspiride on the number of exacerbations and the time of first exacerbation in patients with chronic bronchitis].
abstract: The aim of the work was evaluation of efficacy of fenspiride b.i.d. on the number of exacerbations and the time to the first exacerbation in patients with chronic bronchitis.
  
  
  METHODS
  Randomized, multicentre study controlled versus placebo was carried out in 12 centers in Poland. All patients, 89 females and 68 males aged between 20 and 74, were treated with fenspiride at the dose of 160 mg/day for a period of 6 months. The following symptoms were recorded every month in order to evaluate the therapeutic efficacy: sputum quality and quantity, cough intensity, dyspnea and bronchospasm. Based on these symptoms diagnosis of exacerbation was performed according to American Thoracic Society criteria.
  
  
  RESULTS
  Quality and quantity of sputum and cough significantly improved in the fenspiride group (comparing to the placebo group p= 0.027 and p = 0.049 adequately for sputum and cough). A significant difference between groups was observed in the number of exacerbation episodes and their duration. In the fenspiride group there were 0.53 episodes of exacerbation compared with 1.12 episodes in the placebo group (p = 0.038). Mean duration of exacerbation was 3.3 days in the fenspiride group and 7.3 days in the placebo treated patients (p = 0.034). Time to the first exacerbation differed between groups, but this difference was not statistically significant. Number of side effects observed did not differ between groups.
  
  
  CONCLUSIONS
  Fenspiride treatment was assessed as relatively effective in terms of influence on exacerbations, and well tolerated during six month therapy.
authors.affiliation: Klinika Anestezjologii i Intensywnej Terapii CMKP, Warszawie.
authors.forename: Michał
authors.initials: M
authors.lastname: Pirozyński
authors.forename: Wojciech
authors.initials: W
authors.lastname: Skucha
authors.forename: Marek
authors.initials: M
authors.lastname: Słomiński
authors.forename: Elzbieta
authors.initials: E
authors.lastname: Chyczewska
authors.forename: Janusz
authors.initials: J
authors.lastname: Malinowski
authors.forename: Dariusz
authors.initials: D
authors.lastname: Nowak
authors.forename: Wojciech
authors.initials: W
authors.lastname: Bartmińiski
authors.forename: Robert
authors.initials: R
authors.lastname: Pachocki
mesh_terms: D000328:Adult; D000368:Aged; D001986:Bronchial Spasm / Q000209:etiology / Q000517:prevention & control; D029481:Bronchitis, Chronic / Q000150:complications / Q000188:drug therapy*; D003371:Cough / Q000209:etiology / Q000517:prevention & control; D004417:Dyspnea / Q000209:etiology / Q000517:prevention & control; D005100:Expectorants / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011044:Poland; D013141:Spiro Compounds / Q000008:administration & dosage*; D013183:Sputum / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005100:Expectorants; D013141:Spiro Compounds; C084775:fenspiride