Tiotropium + olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease

A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium + olodaterol fixed dose combination (delivered by the Respimat inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD) - OTEMTO 1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002243-29-FI

Enrollment

1066

Registered

2013-09-17

Start date

2013-10-18

Completion date

Unknown

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease MedDRA version: 16.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855

Interventions

Product Name: Tiotropium 2.5µg/Olodaterol 2.5µg Product Code: Ba 679/BI 1744 Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: TIOTROPIUM CAS Number: 186691-13-4 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosis chronic obstructive pulmonary disease - Relatively stable airway obstruction with post FEV1 >=30 and =65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate maximal treatment effect in FEV1 response and SGRQ total score and safety after 12 weeks of treatment with two different doses of tiotropium + olodaterol fixed dose combination in patients with moderate to severe COPD.;Secondary Objective: Not applicable;Primary end point(s): 1: FEV1 AUC0-3h response (change from baseline) 2: Trough FEV1 response (change from baseline) 3: SGRQ total score (This endpoint will be evaluated in this study and after combining the data from this and the replicate study 1237.26) ;Timepoint(s) of evaluation of this end point: 1: 12-weeks treatment 2: 12 weeks treatment 3: 12 weeks treatment	—

Measure

Time frame

Main Objective: To evaluate maximal treatment effect in FEV1 response and SGRQ total score and safety after 12 weeks of treatment with two different doses of tiotropium + olodaterol fixed dose combination in patients with moderate to severe COPD.;Secondary Objective: Not applicable;Primary end point(s): 1: FEV1 AUC0-3h response (change from baseline) 2: Trough FEV1 response (change from baseline) 3: SGRQ total score (This endpoint will be evaluated in this study and after combining the data from this and the replicate study 1237.26) ;Timepoint(s) of evaluation of this end point: 1: 12-weeks treatment 2: 12 weeks treatment 3: 12 weeks treatment

—

Secondary

Measure	Time frame
Secondary end point(s): 1: TDI focal score (This endpoint will be evaluated in this study and after combining the data from this and the replicate study 1237.26) 2: FVC AUC0-3h response (change from baseline) 3: Trough FVC response (change from baseline) ;Timepoint(s) of evaluation of this end point: 1: 12 weeks treatment 2: 12 weeks treatment 3: 12 weeks treatment	—

Countries

Belgium, Canada, Czech Republic, Denmark, Finland, Germany, Netherlands, South Africa, Spain, Ukraine, United Kingdom, United States

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026