Clareo Health | Comparative Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Exacerbation of Chronic Bronchitis
Comparative Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Exacerbation of Chronic Bronchitis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ambulatory subject who does not require intravenous antibiotic therapy.
Subject who has a medical history of chronic bronchitis.
A history of regular medication use (\>=3 consecutive months within the past 2 years) to treat pulmonary disease.
Subject must have evidence of pulmonary function test abnormalities.
The onset of signs and symptoms of the current exacerbation must occur within 14 days before Evaluation 1.
You may not be if
Medical history of hypersensitivity, allergic or adverse reactions to clarithromycin, erythromycin, or any of the macrolide antibiotics.
A female who is pregnant or is lactating.
Subject who has suspected or known (positive chest radiograph) pneumonia.
Subject who has evidence of significant bronchiectasis (by CT) or atelectasis, active tuberculosis or other mycobacterial infection, bullous emphysema, pulmonary embolism, lung abscess, tumor (primary or metastatic) involving the lung, pleural effusion, or cystic fibrosis that could confound the assessment of signs and symptoms of ABECB.
Subject who requires parenteral antibiotic therapy.
Subject who requires hospitalization for treatment of current episode of ABECB.
Subject who has any other infection or condition, which necessitates use of a concomitant systemic antibiotic.
Subject who has any underlying condition/disease, which would be likely to interfere with the completion of the course or absorption of study drug therapy or follow-up.
Subject who has a severe or complicated lower respiratory tract infection or a severely compromised respiratory status (i.e., oxygen dependent, requiring hospitalization).
