Pulmonary Disease, Chronic ObstructivePhase 2NCT02172352
Dose Ranging Study of Ba 679 BR Inhalation Powder in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 2 study testing Ba 679 BR low dose, Ba 679 BR middle dose and Ba 679 BR high dose in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Ba 679 BR low dose, Ba 679 BR middle dose and Ba 679 BR high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jul 1998to May 1999
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
About this study
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-
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
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Ba 679 BR low dose, Ba 679 BR middle dose, Ba 679 BR high dose, Placebo inhalation powder
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ba 679 BR low doseDrug
Ba 679 BR middle doseDrug
Ba 679 BR high doseDrug
Placebo inhalation powderDrug
| Study group | Role | What they receive |
|---|---|---|
| Ba 679 BR low dose | Experimental | Not described Receives: Drug: Ba 679 BR low dose |
| Placebo inhalation powder | Placebo comparator | Not described Receives: Drug: Placebo inhalation powder |
| Ba 679 BR middle dose | Experimental | Not described Receives: Drug: Ba 679 BR middle dose |
| Ba 679 BR high dose | Experimental | Not described Receives: Drug: Ba 679 BR high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1.0 max (maximum forced expiratory volume in one second)
Measured: before and up to 24 hours after each study drug administration
Secondary outcomes (17)
FEV1.0 AUC 0-24 (forced expiratory volume in one second as area under the curve 0 to 24 hours after administration)
Measured: before and up to 24 hours after each study drug administration
FEV1.0 time to response
Measured: before and up to 24 hours after each study drug administration
FEV1.0 Tmax (time to FEV1.0 max)
Measured: 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
Measured: 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)
Measured: before and up to 24 hours after each study drug administration
FVC max
Measured: 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
Measured: before and up to 24 hours after each study drug administration
Occurrence of adverse events
Measured: up to 29 days
Changes in blood pressure
Measured: before and up to 24 hours after each study drug administration
Changes in pulse rate
Measured: before and up to 24 hours after each study drug administration
Changes in transdermal O2 saturation
Measured: before and up to 24 hours after each study drug administration
Abnormal findings in electrocardiogram (ECG)
Measured: before and 1.5 and 24 hours after each administration of study drug
Abnormal changes in laboratory measurements
Measured: at 24 hours after last study drug administration
Urinary excretion rate
Measured: 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)
Measured: before and up to 24 hours after each study drug administration
MMEF max
Measured: 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
Measured: before and up to 24 hours after each study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJul 1998
- Primary completionMay 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172352
- Sponsor's protocol ID
- 205.139
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-
- ClinicalTrials.gov ID
- NCT02172352
- Acronym / sponsor ID
- 205.139
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 1998
- Primary completion
- May 1999 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ba 679 BR low dose | Experimental | Drug: Ba 679 BR low dose |
| Placebo inhalation powder | Placebo comparator | Drug: Placebo inhalation powder |
| Ba 679 BR middle dose | Experimental | Drug: Ba 679 BR middle dose |
| Ba 679 BR high dose | Experimental | Drug: Ba 679 BR high dose |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ba 679 BR low dose | Drug | Ba 679 BR low dose |
| Ba 679 BR middle dose | Drug | Ba 679 BR middle dose |
| Ba 679 BR high dose | Drug | Ba 679 BR high dose |
| Placebo inhalation powder | Drug | Placebo inhalation powder |
Primary outcome
FEV1.0 max (maximum forced expiratory volume in one second)
Time frame: before and up to 24 hours after each study drug administration
17 secondary outcomes
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
FEV1.0 time to response
Time frame: 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
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
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
FVC max
Time frame: 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
Occurrence of adverse events
Time frame: up to 29 days
Changes in blood pressure
Time frame: 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
Changes in transdermal O2 saturation
Time frame: 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
Abnormal changes in laboratory measurements
Time frame: 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
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
MMEF max
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
- Related InfoLink provided by the sponsor.
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ba 679 BR low dose, Ba 679 BR middle dose and Ba 679 BR high dose in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1.0 max (maximum forced expiratory volume in one second) (time frame: before and up to 24 hours after each study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.