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

NCT ID: NCT02030535

Last Updated: 2015-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-06-30

Brief 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

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tiotropium/Olodaterol FDC

patient will receive tiotropium and olodaterol in a fixed dose combination

Group Type: EXPERIMENTAL

tiotropium

Intervention Type: DRUG

fixed dose combination with olodaterol

olodaterol

Intervention Type: DRUG

fixed dose combination with tiotropium

Tiotropium and Olodaterol FC

patient will receive tiotropium and olodaterol in a free combination

Group Type: EXPERIMENTAL

olodaterol

Intervention Type: DRUG

free combination with tiotropium

tiotropium

Intervention Type: DRUG

free combination with olodaterol

Placebo

patient will receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

olodaterol

free combination with tiotropium

Intervention Type: DRUG

tiotropium

free combination with olodaterol

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

tiotropium

fixed dose combination with olodaterol

Intervention Type: DRUG

olodaterol

fixed dose combination with tiotropium

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1237.7.49004 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1237.7.49005 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1237.7.49007 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

1237.7.49002 Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

1237.7.49003 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

1237.7.49001 Boehringer Ingelheim Investigational Site

Weinheim, , Germany

Countries

Germany

Other Identifiers

2013-002652-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1237.7

Identifier Type: -

Identifier Source: org_study_id