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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: tiotropium; Drug: placebo; Drug: olodaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02006732

2013-002264-24 (EudraCT Number)

1237.26

Details and patient eligibility

About

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.

Enrollment: 809 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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809 participants in 4 patient groups, including a placebo group

tiotropium + olodaterol low dose

Experimental group

Description:

Once daily 2 puffs solution for inhalation Respimat

Treatment:

Drug: olodaterol

Drug: tiotropium

tiotropium + olodaterol high dose

Experimental group

Description:

Once daily 2 puffs solution for inhalation Respimat

Treatment:

Drug: olodaterol

Drug: tiotropium

tiotropium

Active Comparator group

Description:

Once daily 2 puffs solution for inhalation Respimat

Treatment:

Drug: tiotropium

placebo

Placebo Comparator group

Description:

Once daily 2 puffs solution for inhalation Respimat

Treatment:

Drug: placebo