Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients (SECURE2)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: theophylline SR; Drug: Drug: Budesonide/formoterol (Symbicort Turbuhaler; Drug: Drug: ipratropium (AtroventTM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01415518

D589BL00022

Details and patient eligibility

About

Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.

Full description

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.

Enrollment: 581 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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581 participants in 2 patient groups

1

Other group

Description:

budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)

Treatment:

Drug: theophylline SR

Drug: Drug: Budesonide/formoterol (Symbicort Turbuhaler

Drug: Drug: ipratropium (AtroventTM)

2

Other group

Description:

ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)

Treatment:

Drug: theophylline SR

Drug: Drug: ipratropium (AtroventTM)