A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Bronchitis, Chronic

Treatments: Drug: Amoxicillin/clavulinic acid; Drug: Azithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00649831

A0661045

Details and patient eligibility

About

This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.

Enrollment: 250 estimated patients

Sex: All

Ages: 36 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion Criteria:

• Outpatients presenting with an exacerbation of chronic bronchitis including: chronic bronchitis with obstructive respiratory disorders documented by a forced expiratory volume of below 80% and higher than 35% of the theoretical value, within the previous 12 months; and thought to be of infectious origin

Exclusion criteria

Exclusion Criteria:

• Patient not presenting with the associated signs of an exacerbation
• Patient presenting with clinical signs suggestive of pneumonopathy at inclusion
• Patient requiring hospitalisation in intensive care

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Group 2

Active Comparator group

Treatment:

Drug: Amoxicillin/clavulinic acid

Group 1

Active Comparator group

Treatment:

Drug: Azithromycin