Efficacy and Safety of Ba679BR Powder Inhalation in Patients With Chronic Obstructive Pulmonary Disease (COPD)

June 20, 2014 updated by: Boehringer Ingelheim

A Multiple Dose Comparison of 18 µg, 36 µg of Ba679BR (Tiotropium) Inhalation Capsules and Oxitropium Metered Dose Inhaler (2 Puffs of 100µg) in a 4-week, Double-Blind, Double-Dummy, Safety and Efficacy Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study to investigate the efficacy and safety of Ba679BR powder inhalation during the continuous once/day administration to the patients with COPD using oxitropium bromide (Tersigan® aerosol) as the comparator drug.

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.
201

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 3

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:

Diagnosis of COPD (chronic bronchitis, and emphysema) with stable symptoms:

  • Screening FEV1.0 ≤70% of predicted normal vale and screening FEV1.0/FVC ≤70% (the baseline FEV1.0 should also be ≤70% of predicted normal value on the initial day of administration)
  • Smoking history ≥ 10 pack-years (a peak-year is 20 cigarettes per day for one year or equivalent)
  • Male or female patients 40 years of age or older

Exclusion Criteria:

  • History of bronchial asthma
  • History of an atopic disease such as allergic rhinitis
  • Total blood eosinophil count ≥ 600/µL
  • Patient treated with antiallergic drugs or anti-histamine drugs
  • Patients using oral corticosteroid medication at unstable doses (i.e. less than one month on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisolone per day
  • Patients using inhaled steroid, oral β2 stimulant, theophylline preparation, expectorant or macrolide antibiotic at unstable doses (i.e. less than one month on a stable dose)
  • Patients using an ACE inhibitor at unstable doses (i.e. less than one month on a stable dose)
  • Patients with known narrow-angle glaucoma
  • Patients with known symptomatic prostatic hypertrophy
  • Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system
  • Patients with significant diseases who in the opinion of the investigator were not eligible for the study
  • Patients with clinically significant abnormal baseline laboratory test values (hematology, blood chemistry, urinalysis). Patients with serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of the normal range, bilirubin 150% or creatinine 125% of the upper limit of the normal range were excluded
  • Patients with a recent history (i.e. within the 3 months prior to the screening visit) of myocardial infarction or heart failure
  • Patients with any cardiac arrhythmia requiring drug therapy
  • Patients who were treated with Patients who were treated with β-blockers-blockers
  • Patients with regular use of daytime oxygen therapy
  • Patients with known active tuberculosis or with obvious sequela of tuberculosis
  • Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma were allowed
  • Patients with a history of cystic fibrosis or bronchiectasis
  • Patients with upper respiratory tract infection in the past one month prior to the screening visit or during the baseline period
  • Patients who had taken an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit
  • Pregnant or nursing women or women of childbearing potential
  • Other than the above, patients who in the opinion of the investigator were not eligible for the 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: Parallel 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: Tiotropium low & Placebo
Tiotropium 18 µg inhalation capsule and Placebo MDI
Drug: Tiotropium low
Tiotropium 18 µg inhalation capsule
Drug: Placebo MDI
Placebo metered dose inhaler (MDI)
Experimental: Tiotropium high & Placebo
Tiotropium 36 µg inhalation capsule and Placebo MDI
Drug: Placebo MDI
Placebo metered dose inhaler (MDI)
Drug: Tiotropium high
Tiotropium 36 µg inhalation capsule
Active Comparator: Oxitropium & Placebo
Oxitropium MDI (100 µg/puff) and Placebo inhalation capsules
Drug: Placebo inhalation capsule
Drug: Oxitropium
Oxitropium MDI (100 µg/puff)
Other Names:
  • Tersigan®

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
Trough forced expiratory volume in one second (FEV1.0) response
Time Frame: Day 1, week 2 and 4
Day 1, week 2 and 4

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
Occurrence of Adverse Events
Time Frame: up to 4 weeks
up to 4 weeks
FEV1.0 response at 1 hour after administration
Time Frame: Day 1, week 2 and 4
Day 1, week 2 and 4
Trough forced vital capacity (FVC) response
Time Frame: Day 1, week 2 and 4
Day 1, week 2 and 4
FVC response at 1 hour after administration
Time Frame: Day 1, week 2 and 4
Day 1, week 2 and 4
Peak expiratory flow rate (PEF)
Time Frame: in the morning and at evening every day until week 4
in the morning and at evening every day until week 4
COPD symptom scores
Time Frame: until week 4
until week 4
Frequency of rescue use of β2 stimulant
Time Frame: until week 4
until week 4
Patient's impression
Time Frame: week 4
week 4
Physician's global evaluation
Time Frame: week 4
week 4
Change from baseline in blood pressure
Time Frame: Baseline, week 4
Baseline, week 4
Change from baseline in heart rate
Time Frame: Baseline, week 4
Baseline, week 4
Changes in ECG findings
Time Frame: Baseline, week 4
Baseline, week 4
Changes from baseline in laboratory values
Time Frame: Baseline, week 4
Baseline, week 4

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.
December 1, 2000

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.
September 1, 2001

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.
  • 205.226

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.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Clinical Trials on Tiotropium low

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings