Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Severe chronic obstructive pulmonary disease (COPD) patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 581
Healthy volunteers: no

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

Detailed 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.

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

Interventions: intervention 1: Drug: Budesonide/formoterol (Symbicort Turbuhaler intervention 2: Drug: ipratropium (AtroventTM) intervention 3: theophylline SR
Intervention descriptions: intervention 1: budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily) intervention 2: ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) intervention 3: theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)

Protocol document: