Randomised, Double-Blind, Placebo-Controlled, 4-Way Cross-Over Study to Assess the Efficacy and Safety of a Single Dose of Orally Inhaled BEA 2180 BR (Doses 80, 200 and 800 μg) in COPD Patients Followed by an Open-Label, Active-Control (Tiotropium 72 μg)

Boehringer Ingelheim0 sites37 target enrollmentJune 2004

ConditionsPulmonary Disease, Chronic Obstructive

InterventionsBEA 2180 BR Placebo Tiotropium

DrugsBEA 2180 BR Tiotropium Placebo

Overview

Phase: Phase 2
Intervention: BEA 2180 BR
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 37
Primary Endpoint: Change in Mean Forced Expiratory Volume in 1st second (FEV1)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Study to investigate the dose-dependent bronchodilator effect and the safety of single inhalation doses of BEA 2180 inhaled via Respimat® compared to placebo in patients with stable Chronic Obstructive Pulmonary Disease (COPD)

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

December 2004

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All patients have to sign and date an informed consent consistent with International committee on harmonisation (ICH) - Good Clinical Practice (GCP) guidelines prior to participation in the trial, which included medication washout and restrictions
•All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
•Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 ≤ 60% of predicted normal and FEV1 ≤ 70% of FVC (Visits 1 and 2)
•All patients must have an increase in FEV1 of at least 12% from baseline 45 min after inhalation of 80 μg of ipratropium inhaled via Hydro Fluoro Alkane (HFA) - Metered Dose Inhaler (MDI)
•Male or female patients 40 years of age or older. Female patients of child bearing potential could not participate in this study
•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 and inhale medication in a competent manner from the Respimat® device and the HandiHaler®

Exclusion Criteria

•Patients with significant diseases other than Chronic Obstructive Pulmonary Disease (COPD) must be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
•Patients with clinically relevant abnormal baseline hematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease
•Patients with significant prostatic hyperplasia
•Patients with a recent history (i.e. one year or less) of myocardial infarction
•Patients with any unstable or life-threatening cardiac arrhythmia or patients who have been hospitalized for such an event within the past year
•Patients with a history (less than 3 years) of cardiac failure, cor pulmonale or cardiac arrhythmia requiring drug therapy
•Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed
•Patients with known narrow-angle glaucoma
•Patients with a history of asthma, allergic rhinitis or who have a total blood eosinophil count ≥ 600/mm
•A repeat eosinophil count was not conducted in these patients

Arms & Interventions

BEA 2180 - low dose

Intervention: BEA 2180 BR

BEA 2180 - medium dose

Intervention: BEA 2180 BR

BEA 2180 - medium dose

Intervention: Placebo

BEA 2180 - high dose

Intervention: BEA 2180 BR

Tiotropium

Intervention: Tiotropium

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change in Mean Forced Expiratory Volume in 1st second (FEV1)

Time Frame: 23 and 24 hours after single inhalation

Secondary Outcomes

Number of patients with adverse events(up to 85 days)
Time to peak bronchodilatory response(within 3 hours after inhalation of each single dose)
Peak FEV1(within 3 hours after inhalation of each single dose)
Change in Forced Vital Capacity (FVC) AUCtime-interval(predose, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 23, 24, 26 and 28 hours after inhalation of each single dose)
Change in individual FEV1 measurements(up to 71 days)
Maximum measured plasma concentration following the inhalation of each single dose (Cmax)(predose, 5 min, 30min, 2 h, 8 h , 24 h)
Change in FEV1 Area under the concentration-time curve over the respective time interval (AUCtime-interval)(predose, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 23, 24, 26 and 28 hours after inhalation of each single dose)
Change in individual FVC measurements(up to 71 days)
Pre-dose plasma concentration immediately before the inhalation of each single dose (Cpre)(predose)
Time from dosing to the maximum plasma concentration the inhalation of each single dose of randomised treatment (tmax)(predose, 5 min, 30min, 2 h, 8 h , 24 h)
Peak FVC(within 3 hours after inhalation of each single dose)
Area under the plasma concentration-time curve over the respective time interval (AUCtime-interval)(predose, 5 min, 30min, 2 h, 8 h , 24 h)
Amount of unchanged drug excreted over the respective time intervals (Aetime-interval)(predose, 0-4 h, 4-24 h)
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)(predose, 0-4 h, 4-24 h)
Fraction of analyte eliminated in urine from different time intervals (fetime-interval)(predose, 0-4 h, 4-24 h)