Dose Ranging Study of Ba 679 BR Inhalation Powder in Chronic Obstructive Pulmonary Disease (COPD) Patients
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ba 679 BR low dose
Ba 679 BR middle dose
Ba 679 BR high dose
Placebo inhalation powder
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
- In a pulmonary function test of Screening Test II, FEV1.0 was less than 70% of predict normal and FEV1.0 was less than 70% of FVC.
- In the reversibility test of Screening Test II, FEV1.0 was improved by 10% or more at 1 hour after inhalation of 2 puffs of an anticholinergic agent (Tersigan ® Aerozol)
- History of smoking (< no. of cigarettes a day x no. of years of smoking > = 200 or more)
- 40 years of age or older
- Regardless of sex and the length of disease period
Exclusion Criteria:
- A history of bronchial asthma
- A history of atopic disease, such as allergic rhinitis
- Blood eosinophil of 440/µl or more
- Continuous use of steroid drugs (oral administration, inhalation or injection) at a dose equivalent to over 5 mg daily of prednisolone
- A history of respiratory infection, including virus infection within 1 month before study initiation
- Tuberculosis, lung cancer or a history of pneumonectomy
- Glaucoma
- Under treatment of benign prostatic hypertrophy
- Hypersensitivity to anticholinergic agents or sympathomimetics
- Difficulty in expectoration of sputum
- Serious heart disease, renal disease, hepatic disease, endocrine disease or metabolic disease
- Use of any β blockers
- A history of myocardial infarction within the past 1 year
- A history of heart failure, cor pulmonale or arrhythmia requiring medication within the past 3 years
- A history of drug abuse or alcoholism
- Treatment of psychotic disease
- Pregnancy, possible pregnancy or lactation
- A history of participation in any other clinical studies within the past 6 months
- Judgment by the investigator that the patient is ineligible for inclusion in the present study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
Ba 679 BR low dose
Placebo inhalation powder
Ba 679 BR middle dose
Ba 679 BR high dose
Arm Description
Outcomes
Primary Outcome Measures
FEV1.0 max (maximum forced expiratory volume in one second)
Secondary Outcome Measures
FEV1.0 AUC 0-24 (forced expiratory volume in one second as area under the curve 0 to 24 hours after administration)
FEV1.0 time to response
FEV1.0 Tmax (time to FEV1.0 max)
FEV1.0 at measuring time points up to 24 hours after administration of study drug
FVC AUC 0-24 (forced vital capacity as area under the curve 0 to 24 hours after administration)
FVC max
FVC at measuring time points up to 24 hours after administration of study drug
Occurrence of adverse events
Changes in blood pressure
Changes in pulse rate
Changes in transdermal O2 saturation
Abnormal findings in electrocardiogram (ECG)
Abnormal changes in laboratory measurements
Urinary excretion rate
MMEF AUC 0-24 (maximal midexpiratory flow as area under the curve 0 to 24 hours after administration)
MMEF max
MMEF at measuring time points up to 24 hours after administration of study drug
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02172352
Brief Title
Dose Ranging Study of Ba 679 BR Inhalation Powder in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Dose Ranging Study of Ba 679 BR Inhalation Powder Following Single Inhalation in COPD Patients - Double-blind, Placebo-controlled, 4 Treatment, 4 Period Crossover Study-
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
May 1999 (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
To investigate the dose response following single inhalation of Ba 679 BR inhalation powder in COPD patients using pulmonary functions as indicators, and to compare data obtained with overseas study findings
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
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ba 679 BR low dose
Arm Type
Experimental
Arm Title
Placebo inhalation powder
Arm Type
Placebo Comparator
Arm Title
Ba 679 BR middle dose
Arm Type
Experimental
Arm Title
Ba 679 BR high dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ba 679 BR low dose
Intervention Type
Drug
Intervention Name(s)
Ba 679 BR middle dose
Intervention Type
Drug
Intervention Name(s)
Ba 679 BR high dose
Intervention Type
Drug
Intervention Name(s)
Placebo inhalation powder
Primary Outcome Measure Information:
Title
FEV1.0 max (maximum forced expiratory volume in one second)
Time Frame
before and up to 24 hours after each study drug administration
Secondary Outcome Measure Information:
Title
FEV1.0 AUC 0-24 (forced expiratory volume in one second as area under the curve 0 to 24 hours after administration)
Time Frame
before and up to 24 hours after each study drug administration
Title
FEV1.0 time to response
Time Frame
before and up to 24 hours after each study drug administration
Title
FEV1.0 Tmax (time to FEV1.0 max)
Time Frame
before and up to 24 hours after each study drug administration
Title
FEV1.0 at measuring time points up to 24 hours after administration of study drug
Time Frame
before and up to 24 hours after each study drug administration
Title
FVC AUC 0-24 (forced vital capacity as area under the curve 0 to 24 hours after administration)
Time Frame
before and up to 24 hours after each study drug administration
Title
FVC max
Time Frame
before and up to 24 hours after each study drug administration
Title
FVC at measuring time points up to 24 hours after administration of study drug
Time Frame
before and up to 24 hours after each study drug administration
Title
Occurrence of adverse events
Time Frame
up to 29 days
Title
Changes in blood pressure
Time Frame
before and up to 24 hours after each study drug administration
Title
Changes in pulse rate
Time Frame
before and up to 24 hours after each study drug administration
Title
Changes in transdermal O2 saturation
Time Frame
before and up to 24 hours after each study drug administration
Title
Abnormal findings in electrocardiogram (ECG)
Time Frame
before and 1.5 and 24 hours after each administration of study drug
Title
Abnormal changes in laboratory measurements
Time Frame
at 24 hours after last study drug administration
Title
Urinary excretion rate
Time Frame
before (from 4 hours pre-dosing until immediately before dosing) and 0-2, 2-4, 4-8, 8-12 and 12-24 hours after drug administration
Title
MMEF AUC 0-24 (maximal midexpiratory flow as area under the curve 0 to 24 hours after administration)
Time Frame
before and up to 24 hours after each study drug administration
Title
MMEF max
Time Frame
before and up to 24 hours after each study drug administration
Title
MMEF at measuring time points up to 24 hours after administration of study drug
Time Frame
before and up to 24 hours after each study drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In a pulmonary function test of Screening Test II, FEV1.0 was less than 70% of predict normal and FEV1.0 was less than 70% of FVC.
In the reversibility test of Screening Test II, FEV1.0 was improved by 10% or more at 1 hour after inhalation of 2 puffs of an anticholinergic agent (Tersigan ® Aerozol)
History of smoking (< no. of cigarettes a day x no. of years of smoking > = 200 or more)
40 years of age or older
Regardless of sex and the length of disease period
Exclusion Criteria:
A history of bronchial asthma
A history of atopic disease, such as allergic rhinitis
Blood eosinophil of 440/µl or more
Continuous use of steroid drugs (oral administration, inhalation or injection) at a dose equivalent to over 5 mg daily of prednisolone
A history of respiratory infection, including virus infection within 1 month before study initiation
Tuberculosis, lung cancer or a history of pneumonectomy
Glaucoma
Under treatment of benign prostatic hypertrophy
Hypersensitivity to anticholinergic agents or sympathomimetics
Difficulty in expectoration of sputum
Serious heart disease, renal disease, hepatic disease, endocrine disease or metabolic disease
Use of any β blockers
A history of myocardial infarction within the past 1 year
A history of heart failure, cor pulmonale or arrhythmia requiring medication within the past 3 years
A history of drug abuse or alcoholism
Treatment of psychotic disease
Pregnancy, possible pregnancy or lactation
A history of participation in any other clinical studies within the past 6 months
Judgment by the investigator that the patient is ineligible for inclusion in the present study
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.139_U00-0156.pdf
Description
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Dose Ranging Study of Ba 679 BR Inhalation Powder in Chronic Obstructive Pulmonary Disease (COPD) Patients
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