Overview

Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)

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