A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 µg / 5 µg; 5 µg / 5 µg) (delivered by the RESPIMAT) compared with the individual components (2.5 µg and 5 µg tiotropium, 5 µg olodaterol) (delivered by the RESPIMAT) in patients with Chronic Obstructive Pulmonary Disease (COPD) [TOnadoTM 1]

Phase 3

Completed

Conditions: chronic obstructive pulmonary disease
COPD
10038716

Registration Number: NL-OMON35802

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

1. Patients with COPD with specific spirometric criteria(FEV1 < 80% of predicted normal and post-bronchodilator FEV1/FVC < 70% bij visite 1)
2. current or ex-smokers with smoking history of more than 10 pack years
3. male or female patients, 40 years of age or older
See protocol page 22

Exclusion Criteria

1. Other significant disease other than COPD
2. Clinically relevant abnormal baseline lab values
3. History of Asthma
See protocol page 22/23

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>FEV1 AUC 0-3h response<br /><br>Trough FEV1 response<br /><br>TDI (in combination with the data of the sister study 1237.6 (not performed in<br /><br>the Netherlands)<br /><br>Protocol page 40.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>FVC AUC 0-3h response (L)<br /><br>Though FVC response (L)<br /><br>FEV AUC 0-12hr response (L) (substudy patients with12-hr lungfuction<br /><br>assessments)<br /><br>FVC AUC 0-12h response (L) (substudy patients with12-hr lungfuction<br /><br>assessments)<br /><br>FEV1 peak 0-3h response (L)<br /><br>FVC peak 0-3h response (L)<br /><br>FEV1 response (L) at 5, 15 en 30 minutes and at 1, 2 and 3 hours post<br /><br>inhalation of study medication<br /><br>FVC response (L) at 5, 15 en 30 minutes and at 1, 2 and 3 hours post<br /><br>inhalation of studiemedication</p><br>