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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo; Drug: tiotropium; Drug: olodaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02030535

2013-002652-32 (EudraCT Number)

1237.7

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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53 participants in 3 patient groups, including a placebo group

Tiotropium/Olodaterol FDC

Experimental group

Description:

patient will receive tiotropium and olodaterol in a fixed dose combination

Treatment:

Drug: olodaterol

Drug: olodaterol

Drug: tiotropium

Drug: tiotropium

Tiotropium and Olodaterol FC

Experimental group

Description:

patient will receive tiotropium and olodaterol in a free combination

Treatment:

Drug: olodaterol

Drug: olodaterol

Drug: tiotropium

Drug: tiotropium

Placebo

Placebo Comparator group

Description:

patient will receive placebo

Treatment:

Drug: Placebo