Phase 3
Completed N=812
Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01964352 ↗
Enrolled (actual)
812
Serious AEs
3.8%
Results posted
Nov 2015
Primary outcomePrimary: FEV1 AUC0-3h Response — -0.014; 0.205; 0.285; 0.316 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 |
-0.014; 0.205; 0.285; 0.316 | <0.0001 sig |
| PRIMARY Trough FEV1 Response (Change From Baseline) |
0.001; 0.135; 0.151; 0.163 | <0.0001 sig |
| PRIMARY St. George's Respiratory Questionnaire (SGRQ) Total Score |
42.038; 39.637; 37.916; 37.144 | <0.0001 sig |
| SECONDARY Trough Forced Vital Capacity (FVC) Response (Change From Baseline) |
0.025; 0.223; 0.233; 0.244 | <0.0001 sig |
| SECONDARY TDI Focal Score |
-0.113; 1.332; 1.839; 1.939 | <0.0001 sig |
| SECONDARY FVC AUC0-3h Response (Change From Baseline) |
-0.011; 0.286; 0.387; 0.446 | <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 (NCT01964352). 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.