Phase 1
Completed N=32
A Study to Characterize Pharmacokinetics of Tiotropium + Olodaterol Fixed-dose Combination in Japanese Patients With COPD.
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01703845 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Cmax,ss (Olodaterol) — 4.33; 2.82 picogram/milliliter (pg/mL)
Summary
The primary objective of this study is to assess pharmacokinetics of tiotropium + olodaterol fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Japanese patients with COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax,ss (Olodaterol) |
4.33; 2.82 | — |
| PRIMARY AUCt1-t2,ss (Olodaterol) |
9.94; 8.14 | — |
| PRIMARY AUC0-tz,ss (Olodaterol) |
9.94; 6.85 | — |
| PRIMARY Tmax,ss (Olodaterol) |
0.183; 0.217 | — |
| PRIMARY Aet1-t2,ss (Olodaterol) |
74.8; 50.0 | — |
| PRIMARY fe t1-t2,ss (Olodaterol) |
1.50; 0.999 | — |
| PRIMARY CLR,t1-t2,ss (Olodaterol) |
152; 148 | — |
| PRIMARY Cmax,ss (Tiotropium) |
16.5; 6.49 | — |
| PRIMARY AUCt1-t2,ss (Tiotropium) |
14.8; 7.00 | — |
| PRIMARY AUC0-tz,ss (Tiotropium) |
23.3; 7.99 | — |
| PRIMARY Tmax,ss (Tiotropium) |
0.100; 0.100 | — |
| PRIMARY Aet1-t2,ss (Tiotropium) |
336; 122 | — |
| PRIMARY fe t1-t2,ss (Tiotropium) |
6.72; 4.89 | — |
| PRIMARY CLR,t1-t2,ss (Tiotropium) |
292 | — |
| SECONDARY Number of Participants With Adverse Events (Including Assessment Based on Physical Examination) |
4; 2 | — |
| SECONDARY Number of Participants With Clinically Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests and ECG |
0; 0; 0; 0; 0; 1 | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of chronic obstructive pulmonary disease
- Relatively stable airway obstruction with post FEV1=<30% of predicted normal and< 80% predicted normal and post FEV1/FVC <70%
- Male or female Japanese patients, 40 years of age or older
- Smoking history of more than 10 pack years
Exclusion criteria
- Significant disease other than COPD
- Clinically relevant abnormal lab values
- History of asthma
- Diagnosis of thyrotoxicosis
- Diagnosis of paroxysmal tachycardia
- A marked baseline prolongation of QT/QTc interval
- A history of additional risk factors for Torsade de Pointes (TdP)
- History of myocardial infarction within 1 year of screening visit
- Unstable or life-threatening cardiac arrhythmia
- Hospitalization for heart failure within the past year
- Known active tuberculosis
- Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- History of life-threatening pulmonary obstruction
- History of cystic fibrosis
- Clinically evident bronchiectasis
- History of significant alcohol or drug abuse
- Thoracotomy with pulmonary resection
- Oral ß-adrenergics
- Oral corticosteroid medication at unstable doses
- Regular use of daytime oxygen therapy for more than one hour per day
- Pulmonary rehabilitation program in the six weeks prior to the screening visit
- Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
- Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
- Pregnant or nursing women
- Women of childbearing potential not using a highly effective method of birth control
- Patients who have previously been randomized in this study or are currently participating in another study
- Patients who are unable to comply with pulmonary medication restrictions
- Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc
- Patients being treated with medications that prolong the QT/QTc interval
Data sourced from ClinicalTrials.gov (NCT01703845). 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.