Dose Ranging Study of Ba 679 BR Inhalation Powder in Chronic Obstructive Pulmonary Disease (COPD) Patients

June 20, 2014 updated by: Boehringer Ingelheim

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-

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. 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)
  3. History of smoking (< no. of cigarettes a day x no. of years of smoking > = 200 or more)
  4. 40 years of age or older
  5. Regardless of sex and the length of disease period

Exclusion Criteria:

  1. A history of bronchial asthma
  2. A history of atopic disease, such as allergic rhinitis
  3. Blood eosinophil of 440/µl or more
  4. Continuous use of steroid drugs (oral administration, inhalation or injection) at a dose equivalent to over 5 mg daily of prednisolone
  5. A history of respiratory infection, including virus infection within 1 month before study initiation
  6. Tuberculosis, lung cancer or a history of pneumonectomy
  7. Glaucoma
  8. Under treatment of benign prostatic hypertrophy
  9. Hypersensitivity to anticholinergic agents or sympathomimetics
  10. Difficulty in expectoration of sputum
  11. Serious heart disease, renal disease, hepatic disease, endocrine disease or metabolic disease
  12. Use of any β blockers
  13. A history of myocardial infarction within the past 1 year
  14. A history of heart failure, cor pulmonale or arrhythmia requiring medication within the past 3 years
  15. A history of drug abuse or alcoholism
  16. Treatment of psychotic disease
  17. Pregnancy, possible pregnancy or lactation
  18. A history of participation in any other clinical studies within the past 6 months
  19. Judgment by the investigator that the patient is ineligible for inclusion in the present study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ba 679 BR low dose
Drug: Ba 679 BR low dose
Placebo Comparator: Placebo inhalation powder
Drug: Placebo inhalation powder
Experimental: Ba 679 BR middle dose
Drug: Ba 679 BR middle dose
Experimental: Ba 679 BR high dose
Drug: Ba 679 BR high dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
FEV1.0 max (maximum forced expiratory volume in one second)
Time Frame: before and up to 24 hours after each study drug administration
before and up to 24 hours after each study drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
before and up to 24 hours after each study drug administration
FEV1.0 time to response
Time Frame: before and up to 24 hours after each study drug administration
before and up to 24 hours after each study drug administration
FEV1.0 Tmax (time to FEV1.0 max)
Time Frame: before and up to 24 hours after each study drug administration
before and up to 24 hours after each study drug administration
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
before and up to 24 hours after each study drug administration
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
before and up to 24 hours after each study drug administration
FVC max
Time Frame: before and up to 24 hours after each study drug administration
before and up to 24 hours after each study drug administration
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
before and up to 24 hours after each study drug administration
Occurrence of adverse events
Time Frame: up to 29 days
up to 29 days
Changes in blood pressure
Time Frame: before and up to 24 hours after each study drug administration
before and up to 24 hours after each study drug administration
Changes in pulse rate
Time Frame: before and up to 24 hours after each study drug administration
before and up to 24 hours after each study drug administration
Changes in transdermal O2 saturation
Time Frame: before and up to 24 hours after each study drug administration
before and up to 24 hours after each study drug administration
Abnormal findings in electrocardiogram (ECG)
Time Frame: before and 1.5 and 24 hours after each administration of study drug
before and 1.5 and 24 hours after each administration of study drug
Abnormal changes in laboratory measurements
Time Frame: at 24 hours after last study drug administration
at 24 hours after last study drug administration
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
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
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
before and up to 24 hours after each study drug administration
MMEF max
Time Frame: before and up to 24 hours after each study drug administration
before and up to 24 hours after each study drug administration
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
before and up to 24 hours after each study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 1998

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 1999

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 205.139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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