Pulmonary Disease, Chronic ObstructivePhase 2NCT02242279
Study to Evaluate Efficacy and Safety of Inhaled BEA 2180 BR in COPD Patients
A Phase 2 study testing BEA 2180 BR and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial 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) 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?
- BEA 2180 BR and Tiotropium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Dec 2004
- 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
- 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®
Who cannot join
- 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
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- 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
About this study
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 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)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- BEA 2180 BR, Tiotropium, Placebo
- 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.
BEA 2180 BRDrug
TiotropiumDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BEA 2180 - low dose | Experimental | Not described Receives: Drug: BEA 2180 BR |
| BEA 2180 - medium dose | Experimental | Not described Receives: Drug: BEA 2180 BR; Drug: Placebo |
| BEA 2180 - high dose | Experimental | Not described Receives: Drug: BEA 2180 BR |
| Tiotropium | Active comparator | Not described Receives: Drug: Tiotropium |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Forced Expiratory Volume in 1st second (FEV1)
Measured: 23 and 24 hours after single inhalation
Secondary outcomes (15)
Change in FEV1 Area under the concentration-time curve over the respective time interval (AUCtime-interval)
Measured: predose, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 23, 24, 26 and 28 hours after inhalation of each single dose
Peak FEV1
Measured: within 3 hours after inhalation of each single dose
Time to peak bronchodilatory response
Measured: within 3 hours after inhalation of each single dose
Change in Forced Vital Capacity (FVC) AUCtime-interval
Measured: predose, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 23, 24, 26 and 28 hours after inhalation of each single dose
Change in individual FEV1 measurements
Measured: up to 71 days
Change in individual FVC measurements
Measured: up to 71 days
Number of patients with adverse events
Measured: up to 85 days
Area under the plasma concentration-time curve over the respective time interval (AUCtime-interval)
Measured: predose, 5 min, 30min, 2 h, 8 h , 24 h
Pre-dose plasma concentration immediately before the inhalation of each single dose (Cpre)
Measured: predose
Maximum measured plasma concentration following the inhalation of each single dose (Cmax)
Measured: predose, 5 min, 30min, 2 h, 8 h , 24 h
Time from dosing to the maximum plasma concentration the inhalation of each single dose of randomised treatment (tmax)
Measured: predose, 5 min, 30min, 2 h, 8 h , 24 h
Amount of unchanged drug excreted over the respective time intervals (Aetime-interval)
Measured: predose, 0-4 h, 4-24 h
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)
Measured: predose, 0-4 h, 4-24 h
Fraction of analyte eliminated in urine from different time intervals (fetime-interval)
Measured: predose, 0-4 h, 4-24 h
Peak FVC
Measured: within 3 hours after inhalation of each single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startJun 2004
- Primary completionDec 2004
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
- 37 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
- NCT02242279
- Sponsor's protocol ID
- 1205.3
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02242279
- Acronym / sponsor ID
- 1205.3
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Dec 2004 (actual)
- First posted
- 17 Sep 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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BEA 2180 - low dose | Experimental | Drug: BEA 2180 BR |
| BEA 2180 - medium dose | Experimental | Drug: BEA 2180 BR, Drug: Placebo |
| BEA 2180 - high dose | Experimental | Drug: BEA 2180 BR |
| Tiotropium | Active comparator | Drug: Tiotropium |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (28 listed)
- 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
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 |
|---|---|---|
| BEA 2180 BR | Drug | BEA 2180 - high dose, BEA 2180 - low dose, BEA 2180 - medium dose |
| Tiotropium | Drug | Tiotropium |
| Placebo | Drug | BEA 2180 - medium dose, Placebo |
Primary outcome
Change in Mean Forced Expiratory Volume in 1st second (FEV1)
Time frame: 23 and 24 hours after single inhalation
15 secondary outcomes
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
Peak FEV1
Time frame: within 3 hours after inhalation of each single dose
Time to peak bronchodilatory response
Time frame: within 3 hours after inhalation of each single dose
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
Change in individual FEV1 measurements
Time frame: up to 71 days
Change in individual FVC measurements
Time frame: up to 71 days
Number of patients with adverse events
Time frame: up to 85 days
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
Pre-dose plasma concentration immediately before the inhalation of each single dose (Cpre)
Time frame: predose
Maximum measured plasma concentration following the inhalation of each single dose (Cmax)
Time frame: predose, 5 min, 30min, 2 h, 8 h , 24 h
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
Amount of unchanged drug excreted over the respective time intervals (Aetime-interval)
Time frame: predose, 0-4 h, 4-24 h
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
Fraction of analyte eliminated in urine from different time intervals (fetime-interval)
Time frame: predose, 0-4 h, 4-24 h
Peak FVC
Time frame: within 3 hours after inhalation of each single dose
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 17 Sep 2014.
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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 BEA 2180 BR and Tiotropium 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 8 inclusion and 28 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 17 Sep 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?
Change in Mean Forced Expiratory Volume in 1st second (FEV1) (time frame: 23 and 24 hours after single inhalation). 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 17 Sep 2014.