Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Olodaterol; Tiotropium Bromide

Criteria

Inclusion criteria:

• Diagnosis chronic obstructive pulmonary disease

• Relatively stable airway obstruction with post FEV1 >=30 and < 80% predicted normal and post FEV1/ FVC < 70%

• Male or female patients, 40 years of age or more

• Smoking history more than 10 pack years

Exclusion criteria:

• Significant diseases other than COPD

• History of asthma

• COPD exacerbation in previous 3 months

• Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program.

• Pregnant or nursing women

• Patients unable to comply with pulmonary medication restrictions