Phase 3
Completed N=122
Japan Long-term Safety for Tiotropium Plus Olodaterol
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01536262 ↗
Enrolled (actual)
122
Serious AEs
11.5%
Results posted
Jul 2015
Primary outcomePrimary: Number (%) of Patients With Drug-related AEs — 4.9; 5.0; 7.3 percentage of participants
Summary
The primary objective of this study is to assess the safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number (%) of Patients With Drug-related AEs |
4.9; 5.0; 7.3 | — |
| SECONDARY FEV1 AUC0-3h Response |
0.132; 0.260; 0.237 | — |
| SECONDARY Trough FEV1 Response |
0.075; 0.168; 0.143 | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of chronic obstructive pulmonary disease.
- Relatively stable airway obstruction with post FEV1< 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
- 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 are unable to comply with pulmonary medication restrictions
- Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc.
Data sourced from ClinicalTrials.gov (NCT01536262). 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.