Phase 3
Completed N=809
Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT02006732 ↗
Enrolled (actual)
809
Serious AEs
3.2%
Results posted
Jan 2016
Primary outcomePrimary: FEV1 AUC0-3h Response — -0.006; 0.188; 0.279; 0.293 L — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1 AUC0-3h Response |
-0.006; 0.188; 0.279; 0.293 | <0.0001 sig |
| PRIMARY Trough FEV1 Response (Change From Baseline) |
-0.003; 0.124; 0.166; 0.163 | <0.0001 sig |
| PRIMARY St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study |
42.575; 39.729; 38.909; 38.011 | <0.0001 sig |
| PRIMARY St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352 |
42.265; 39.694; 38.419; 37.597 | <0.0001 sig |
| SECONDARY Trough Forced Vital Capacity (FVC) Response (Change From Baseline) |
-0.021; 0.170; 0.284; 0.231 | <0.0001 sig |
| SECONDARY TDI Focal Score Based on Data From This Individual Study |
0.337; 0.950; 1.599; 1.531 | <0.0001 sig |
| SECONDARY TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352 |
0.111; 1.140; 1.722; 1.734 | <0.0001 sig |
| SECONDARY FVC AUC0-3h Response (Change From Baseline) |
-0.018; 0.266; 0.436; 0.414 | <0.0001 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02006732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.