Overview

Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
Summary
This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Formoterol Fumarate
Tiotropium Bromide
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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 and also the patients who use of systemic glucocorticosteroids (GCS)
within 4 weeks and/or inhaled GCS within 2 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