[Evaluation and symptomatic treatment of surinfectious exacerbations of COPD: preliminary study of antibiotic treatment combined with fenspiride (Pneumorel 80mg) versus placebo].
Exacerbations of chronic obstructive pulmonary disease (COPD) have an inflammatory component in addition to the possible infectious component. The antiinflammatory properties of fenspiride (Pneumorel(R) 80 mg) should be evaluated in this frequent clinical situation.


OBJECTIVE
Assess the supplementary therapeutic benefit provided by fenspiride administered in combination with antibiotics in COPD patients presenting an episode of bronchial infection.


METHODS
A preliminary randomized placebo-controlled double-blind study was conduced in 7 centers. Patients under 80 years of age of both sexes were included. All patients had COPD and presented a bronchial infection defined as the presence of at least 2 of the 3 criteria defined by Anthonisen. Patients were randomly assigned to group F or group P. Group F received an antibiotic therapy from day 1 to day 11 plus fenspiride (3 x 80mg/d from day 0 to day 30). Group P received the same antibiotic therapy plus placebo. Amoxicillin 500mg plus clavulanic acid 125, 3 tablets/day, was administered in both groups.


RESULTS
Thirty-nine patients were included (group F 19 patients, group P 20 patients; 6 women and 33 men; mean age 61.1 +/- 9.8 years). The 3 Anthonisen criteria were present in 79% and 75% of the patients in group F and P respectively (NS). On day 11, expectoration resolved in 39% and 32% (NS) and cough in 44% and 16% (NS) of the patients in groups F and P respectively. Lung auscultation returned to normal in 83% of the patients in group F compared with 47% in group P (p=0.05). A composite clinical score including expectoration cough and auscultation findings showed that 28% of the patients in group F were symptom-free on day 11 compared with 0% in group P (p=0.04). On day 30, the two groups were comparable.


CONCLUSIONS
In this preliminary study of patients with COPD presenting a bronchial superinfection, there was a significant improvement in lung auscultation and in the composite clinical score in patients given fenspiride. Fenspiride was thus found to provide an early clinical benefit.
Lirsac
B
B
Centre de Pneumologie, avenue Ribère, 66000 Perpignan.
Benezet
O
O
Dansin
E
E
Nouvet
G
G
Stach
B
B
Voisin
C
C
D000208:Acute Disease; D000368:Aged; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001991:Bronchitis / Q000188:drug therapy* / Q000209:etiology* / Q000276:immunology; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008173:Lung Diseases, Obstructive / Q000150:complications*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013141:Spiro Compounds / Q000627:therapeutic use*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D001993:Bronchodilator Agents; D016861:Cyclooxygenase Inhibitors; D013141:Spiro Compounds; D019980:Amoxicillin-Potassium Clavulanate Combination; C084775:fenspiride