Question 11

Could you comment on the use of symptom resolution as the endpoint of your study?

A subset of patients maintained a daily symptom diary and monitored cough, breathlessness and sputum production. Each symptom was scored on a 0-3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms). Allowing for a total score of 9. Improvement was predefined a 1 point reduction in total symptoms from the baseline value. Patient-recorded diary entries indicated that respiratory symptoms were significantly improved by day 3 (p = 0.015) in the uncomplicated levofloxacin group compared with azithromycin. For complicated patients, by the on-therapy physician visit, more levofloxacin than amoxicillin/clavulanate patients experienced resolution of their cough as well as reduction of sputum volume and sputum purulence, as assessed by the study investigator (Figure 1) (17).

Figure 1. Resolution of symptoms in complicated patients treated with levofloxacin vs. amoxicillin/clavulanate

Resolution of symptoms from the baseline visit to the on-treatment visit (days 3.6 after the administration of the first dose of active drug) in the microbiologically assessable population (n. = 175) of 362 patients receiving levofloxacin 750 mg q.d. for 5 days (n = 86) or amoxicillin/ clavulanate 875 mg/125mg b.i.d. for 10days (n = 89) for the treatment of severe acute bacterial exacerbation of chronic bronchitis. Resolution was defined as symptom presence at study entry and absence at on-treatment visit.
Abbreviations: b.i.d. = twice daily, q.d. = once daily.
Adapted from reference (17).