Study to Evaluate Efficacy and Safety of Inhaled BEA 2180 BR in COPD Patients
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BEA 2180 BR
Tiotropium
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
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/mm3. A repeat eosinophil count was not conducted in these patients
- Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
- Patients with known active tuberculosis
- Patients with a history of and/or active significant alcohol or drug abuse
- Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons must be excluded
- Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1)
- Patients who regularly used daytime oxygen therapy
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
- Patients who are being treated with oral beta-adrenergic
- Patients who are being treated with beta-blockers
- Patients who are being treated with cromolyn sodium or nedocromil sodium
- Patients who are being treated with antihistamines (H1 receptor antagonists), antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions
- Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
- Patients with known hypersensitivity to anticholinergic drugs, beta-adrenergic, lactose or any other components of the medication delivery systems
Pregnant or nursing women or women of childbearing potential. Female patients have to be either:
- Surgically sterilized by hysterectomy or bilateral tubal ligation or
- Post-menopausal for at least two years
- Patients with previous participation (receipt of randomized treatment) in this study
- Patients who are participating in another study
- The randomization of patients with any respiratory infection or COPD exacerbation in the six weeks prior to the Screening Visit (Visit 1) or during the baseline period must be postponed. Patients could be randomized six weeks following recovery from the infection or exacerbation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
BEA 2180 - low dose
BEA 2180 - medium dose
BEA 2180 - high dose
Tiotropium
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Mean Forced Expiratory Volume in 1st second (FEV1)
Secondary Outcome Measures
Change in FEV1 Area under the concentration-time curve over the respective time interval (AUCtime-interval)
Peak FEV1
Time to peak bronchodilatory response
Change in Forced Vital Capacity (FVC) AUCtime-interval
Change in individual FEV1 measurements
Change in individual FVC measurements
Number of patients with adverse events
Area under the plasma concentration-time curve over the respective time interval (AUCtime-interval)
Pre-dose plasma concentration immediately before the inhalation of each single dose (Cpre)
Maximum measured plasma concentration following the inhalation of each single dose (Cmax)
Time from dosing to the maximum plasma concentration the inhalation of each single dose of randomised treatment (tmax)
Amount of unchanged drug excreted over the respective time intervals (Aetime-interval)
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)
Fraction of analyte eliminated in urine from different time intervals (fetime-interval)
Peak FVC
Full Information
NCT ID
NCT02242279
First Posted
September 16, 2014
Last Updated
September 16, 2014
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT02242279
Brief Title
Study to Evaluate Efficacy and Safety of Inhaled BEA 2180 BR in COPD Patients
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BEA 2180 - low dose
Arm Type
Experimental
Arm Title
BEA 2180 - medium dose
Arm Type
Experimental
Arm Title
BEA 2180 - high dose
Arm Type
Experimental
Arm Title
Tiotropium
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BEA 2180 BR
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Mean Forced Expiratory Volume in 1st second (FEV1)
Time Frame
23 and 24 hours after single inhalation
Secondary Outcome Measure Information:
Title
Change in FEV1 Area under the concentration-time curve over the respective time interval (AUCtime-interval)
Time Frame
predose, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 23, 24, 26 and 28 hours after inhalation of each single dose
Title
Peak FEV1
Time Frame
within 3 hours after inhalation of each single dose
Title
Time to peak bronchodilatory response
Time Frame
within 3 hours after inhalation of each single dose
Title
Change in Forced Vital Capacity (FVC) AUCtime-interval
Time Frame
predose, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 23, 24, 26 and 28 hours after inhalation of each single dose
Title
Change in individual FEV1 measurements
Time Frame
up to 71 days
Title
Change in individual FVC measurements
Time Frame
up to 71 days
Title
Number of patients with adverse events
Time Frame
up to 85 days
Title
Area under the plasma concentration-time curve over the respective time interval (AUCtime-interval)
Time Frame
predose, 5 min, 30min, 2 h, 8 h , 24 h
Title
Pre-dose plasma concentration immediately before the inhalation of each single dose (Cpre)
Time Frame
predose
Title
Maximum measured plasma concentration following the inhalation of each single dose (Cmax)
Time Frame
predose, 5 min, 30min, 2 h, 8 h , 24 h
Title
Time from dosing to the maximum plasma concentration the inhalation of each single dose of randomised treatment (tmax)
Time Frame
predose, 5 min, 30min, 2 h, 8 h , 24 h
Title
Amount of unchanged drug excreted over the respective time intervals (Aetime-interval)
Time Frame
predose, 0-4 h, 4-24 h
Title
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)
Time Frame
predose, 0-4 h, 4-24 h
Title
Fraction of analyte eliminated in urine from different time intervals (fetime-interval)
Time Frame
predose, 0-4 h, 4-24 h
Title
Peak FVC
Time Frame
within 3 hours after inhalation of each single dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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/mm3. A repeat eosinophil count was not conducted in these patients
Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
Patients with known active tuberculosis
Patients with a history of and/or active significant alcohol or drug abuse
Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons must be excluded
Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1)
Patients who regularly used daytime oxygen therapy
Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
Patients who are being treated with oral beta-adrenergic
Patients who are being treated with beta-blockers
Patients who are being treated with cromolyn sodium or nedocromil sodium
Patients who are being treated with antihistamines (H1 receptor antagonists), antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions
Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
Patients with known hypersensitivity to anticholinergic drugs, beta-adrenergic, lactose or any other components of the medication delivery systems
Pregnant or nursing women or women of childbearing potential. Female patients have to be either:
Surgically sterilized by hysterectomy or bilateral tubal ligation or
Post-menopausal for at least two years
Patients with previous participation (receipt of randomized treatment) in this study
Patients who are participating in another study
The randomization of patients with any respiratory infection or COPD exacerbation in the six weeks prior to the Screening Visit (Visit 1) or during the baseline period must be postponed. Patients could be randomized six weeks following recovery from the infection or exacerbation
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
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Study to Evaluate Efficacy and Safety of Inhaled BEA 2180 BR in COPD Patients
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