Phase 2 Completed N=53 Randomized Double-blind Treatment

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

Pulmonary Disease, Chronic Obstructive

Source: ClinicalTrials.gov NCT02030535 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Jul 2015

Primary outcomePrimary: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration — 0.014; 0.233; 0.266 Litres — p=<0.0001

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration	0.014; 0.233; 0.266	<0.0001 sig
SECONDARY Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points	1.3; 2.2; 1.9	—
SECONDARY Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points	5.2; 5.7; 5.7	—
SECONDARY Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points	-3.0; -2.5; -3.6	—
SECONDARY Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points	-0.7; -0.3; -1.2	—
SECONDARY Heart Rate Change From Patient Baseline at Individual Post-dose Time Points	-2.3; -2.5; -2.9; -2.7; -2.4; -3.1	—
SECONDARY Mean RR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	40.4; 29.3; 39.5	—
SECONDARY Peak RR Change From Patient Baseline Over All Post-dose Time Points	68.8; 55.5; 68.0	—
SECONDARY RR Change From Patient Baseline at Individual Post-dose Time Points	29.9; 29.7; 31.9; 38.8; 28.1; 33.5	—
SECONDARY Mean QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	7.2; 6.5; 7.9	—
SECONDARY Peak QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	12.4; 11.5; 13.4	—
SECONDARY QT Change From Patient Baseline at Individual Post-dose Time Points	4.3; 5.5; 4.9; 7.1; 6.3; 7.9	—
SECONDARY Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points	-1.9; -0.2; -1.4	—
SECONDARY Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points	3.0; 4.2; 3.5	—
SECONDARY QTcB Change From Patient Baseline at Individual Post-dose Time Points	-2.5; -1.4; -2.6; -1.4; -0.2; -0.0	—
SECONDARY Mean PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	0.6; 1.6; 1.4	—
SECONDARY Peak PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	3.9; 4.6; 4.7	—
SECONDARY PR Change From Patient Baseline at Individual Post-dose Time Points	0.1; 1.2; -0.2; 0.1; 2.5; 1.4	—
SECONDARY Mean QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	-0.3; 0.1; 0.1	—
SECONDARY Peak QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	0.6; 0.9; 1.0	—
SECONDARY QRS Change From Patient Baseline at Individual Post-dose Time Points	-0.3; -0.2; -0.0; -0.3; 0.1; 0.1	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02030535). 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.