Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Efficacy and tolerability study of Symbicort Turbuhaler (160/4.5µg/inhalation,2inhalations twice daily) added to Atrovent (20µg/inhalation, 2 inhalations 4 times daily) + theophylline SR(0.1g/tablet, 1 tablet p.o. twice daily) compared with Atrovent + theophylline SR in severe COPD patients.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed and dated informed consent
Men or women patients ≥ 40 years of age
Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2
Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) \< 70%, pre-bronchodilator
Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period
You may not be if
A history of asthma and seasonal allergic rhinitis before 40 years of age
Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period
Patients with relevant cardiovascular disorder judged by the investigator
Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator
Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator
Clareo Health | Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
