Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy and safety of orally inhaled tiotropium and olodaterol as both a fixed dose combination and a free combination with respect to lung function and ECG parameters

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Olodaterol; Tiotropium Bromide

Criteria

Inclusion criteria:

• patients must sign informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.

• Patients must have a diagnosis of COPD and must meet the following spirometric criteria:

Patients must have relatively stable airway obstruction with a post-bronchodilator (10 to 45 minutes after 400mcg salbutamol) FEV1>30% and < 80% of predicted normal (ECSC, GOLD II - III) and a post-bronchodilator FEV1/FVC <70% at Visit 1

• Male or female patients, 40 years of age or older.

• Patients must be current or ex-smokers with a smoking history of more than 10 pack years.

• Patients who have never smoked cigarettes must be excluded.

• Patients must be able to perform technically acceptable pulmonary function tests according to ATS/ERS guidelines and maintain records in a paper diary

• Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).

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 and patients with chronic respiratory failure

• History of cystic fibrosis

• Clinically evident bronchiectasis

• History of significant alcohol or drug abuse

• Thoracotomy with pulmonary resection

• Patients treated with oral or patch ß-adrenergics

• Patients treated with oral corticosteroid medication at unstable doses or at doses in excess of 10mg prednisolone per day or equivalent

• 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 or patients currently in a pulmonary rehabilitation program

• Investigational drug within one month or six half lives (whichever is greater) prior to screening visit

• Known hypersensitivity to ß-adrenergic and/or anticholinergic drugs, BAC, EDTA

• Pregnant or nursing women

• Women of childbearing potential not using a highly effective method of birth control

• Patient 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 prior to randomization