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]

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] - Efficacy and safety tiotropium plus olodaterol

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35802

Enrollment

Registered

2011-06-10

Start date

2011-10-05

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

chronic obstructive pulmonary disease COPD

Interventions

Once daily inhalation of study medication with the Respimat® Inhaler (1:1:1:1:1) randomisation to one of the following groups: - tiotropium plus olodaterol (FDC) 2,5 mcg / 5 mcg) inhalation solution

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with COPD with specific spirometric criteria(FEV1

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
FEV1 AUC 0-3h response Trough FEV1 response TDI (in combination with the data of the sister study 1237.6 (not performed in the Netherlands) Protocol page 40.	—

Secondary

Measure	Time frame
FVC AUC 0-3h response (L) Though FVC response (L) FEV AUC 0-12hr response (L) (substudy patients with12-hr lungfuction assessments) FVC AUC 0-12h response (L) (substudy patients with12-hr lungfuction assessments) FEV1 peak 0-3h response (L) FVC peak 0-3h response (L) FEV1 response (L) at 5, 15 en 30 minutes and at 1, 2 and 3 hours post inhalation of study medication FVC response (L) at 5, 15 en 30 minutes and at 1, 2 and 3 hours post inhalation of studiemedication	—

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)