Pulmonary Disease, Chronic ObstructivePhase 2NCT02249338
Effect of BIIL 284 BS on Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing BIIL 284 BS in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Study to investigate the effect of 14-day treatment with BIIL 284 BS on sputum neutrophils and specific inflammatory markers in patients with clinically well-defined moderate chronic obstructive pulmonary disease (COPD) Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- BIIL 284 BS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Oct 1999to Apr 2000
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of COPD as defined by the American Thoracic Society criteria. Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 ≤ 70 % of predicted value and FEV1/FVC ≤ 70 % at Screening Visit 1
- Ability to produce an adequate induced sputum sample ad defined by: volume > 1 ml: squamous cells less than 80% and the ability to tolerate the procedure for at least four minutes with no bronchoconstriction ( a fall in FEV1 ≥ 20%)
- Greater than 50% of neutrophils in induced-sputum cells at visit 1. This requirement refers to the neutrophils percentage excluding squamous cells
- Males or females aged 40 to 80 years inclusive.
- Female patients of childbearing potential cannot participate in this study. Female patients participating in this study must meet at least one of the following criteria:
- surgically sterilized by hysterectomy or bilateral tubal ligation
Show all 10Show fewer
- post-menopausal for at least two years
- A smoking history of more than ten pack years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
- Patients must be able to perform pulmonary function tests and maintain records during the study period as required in the protocol
- All patients must sign an Informed Consent Form prior tho participation in the trial, i.e., prior to pre-study washout of their usual pulmonary medications
Who cannot join
- Culture-documented and/or radiographic evidence and/or antibiotic treatment of an upper or lower respiratory tract infection within the previous 4 weeks or during the baseline period of this study
- Significant diseases other than COPD will be exclude. 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 inflammatory diseases e.g. rheumatoid arthritis, and those with autoimmune diseases will be excluded
- Clinically significant abnormal baseline haematology, liver function, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded. Laboratory parameters listed in the protocol must be within normal range, or if not, be documented by the investigator as not clinically relevant. The following tests may be outside the normal range to the extent indicated:
- Aspartate transaminase, Alanine transaminase, Total Bilirubin, Alkaline Phosphatase: 10% > upper limit of normal (ULN)
- White blood cell count < 3.80 x 109/L, Neutrophils < 2.00 x 109/L, Platelets < 100 x 10**9/L, Hemoglobin < 12 x g/dL
- Urea Nitrogen, Creatinine: 10% > ULN
Show all 17Show fewer
- A recent history (i.e. within six months) of myocardial infarction
- A recent history (i.e. within three months) of refractory heart failure or unstable arrhythmias requiring treatment
- Patients with known active tuberculosis
- A history of cancer within the last five years. Patients with treated basal cell carcinoma or cutaneous squamous cell carcinoma are allowed
- A history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
- Previous thoracotomy with pulmonary resection. Patients with a history of a thoracotomy without pulmonary resection should be evaluated as per exclusion criterion no. 2
- The use of oral corticosteroids within 4 weeks, or theophyllines and oral or long-acting inhaled beta2-agonists within 2 weeks of visit 1
- A change in pulmonary therapy within the 6 weeks prior to the screening visit 1 in order to control the patient's COPD
- A history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600/mm**3
- A history of and/or current alcohol abuse and/or drug abuse
- Use of an investigational drug within one month or six half-lives (which ever is greater) of the screening visit 1
About this study
Official title: Effect of 14-Day Treatment With BIIL 284 BS on Patients With COPD (Double-Blind, Placebo-Controlled, Randomised, Parallel Group Study)
Study to investigate the effect of 14-day treatment with BIIL 284 BS on sputum neutrophils and specific inflammatory markers in patients with clinically well-defined moderate chronic obstructive pulmonary disease (COPD)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- BIIL 284 BS, 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.
BIIL 284 BSDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIIL 284 BS | Experimental | Not described Receives: Drug: BIIL 284 BS |
| 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.
Percentage of neutrophils in the induced sputum differential cell count
Measured: Baseline, day 14
Secondary outcomes (32)
Percentage of neutrophils in the spontaneous sputum differential cell count
Measured: Baseline, day 14
Percentage of neutrophils in the induced sputum differential cell count
Measured: Baseline, day 28
Percentage of neutrophils in the spontaneous sputum differential cell count
Measured: Baseline, day 28
Differential cell count in induced sputum
macrophages, lymphocytes, eosinophils, basophils and epithelial cells
Measured: Baseline, day 14 and 28
Differential cell count in spontaneous sputum
macrophages, lymphocytes, eosinophils, basophils and epithelial cells
Measured: Baseline, day 14 and 28
Wet weight of spontaneous sputum
collected over a 24 hours period the day before each clinic visit
Measured: Day -6, 0, 6, 13 and 27
Concentration of myeloperoxidase (MPO) in induced sputum
Measured: Baseline, day 14 and 28
Concentration of myeloperoxidase (MPO) in spontaneous sputum
Measured: Baseline, day 14 and 28
Concentration of neutrophil elastase (NE) in induced sputum
Measured: Baseline, day 14 and 28
Concentration of neutrophil elastase (NE) in spontaneous sputum
Measured: Baseline, day 14 and 28
Concentration of interleukin-8 (IL-8) in induced sputum
Measured: Baseline, day 14 and 28
Concentration of interleukin-8 (IL-8) in spontaneous sputum
Measured: Baseline, day 14 and 28
Concentration of leukotriene B4 (LTB4) in induced sputum
Measured: Baseline, day 14 and 28
Concentration of leukotriene B4 (LTB4) in spontaneous sputum
Measured: Baseline, day 14 and 28
Concentration of albumin in induced sputum
Measured: Baseline, day 14 and 28
Concentration of albumin in spontaneous sputum
Measured: Baseline, day 14 and 28
Sputum bacterial load of induced sputum
Measured: Baseline, day 14 and 28
Sputum bacterial load of spontaneous sputum
Measured: Baseline, day 14 and 28
Sputum chemotactic activity of induced sputum
Measured: Baseline, day 14 and 28
Sputum chemotactic activity of spontaneous sputum
Measured: Baseline, day 14 and 28
Inhibition of blood neutrophil Mac-1 expression
both unstimulated and LTB4-stimulated
Measured: Day 1 and 14
Inhibition of blood neutrophil chemotaxis response to LTB4
Measured: Day 1 and 14
Forced expiratory volume in one second (FEV1)
Measured: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Forced vital capacity (FVC)
Measured: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Forced expiratory flow (FEF25-75%)
Measured: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Peak expiratory flow rate (PEFR)
Measured: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Inspiratory capacity (IC)
Measured: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Slow vital capacity (SVC)
Measured: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Changes in COPD symptom score
dyspnoea, fatigue, orthopnea, paroxysmal nocturnal dyspnoea and cough
Measured: Baseline, Day 1, 7 and 14
Physician's global evaluation of symptoms assessed on a 4-point scale
Measured: Baseline, Day 14
Number of patients with adverse events
Measured: up to 6 weeks
Plasma concentrations of the analytes
Measured: 30 min before, 90 and 240 min after drug administration on day 1 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startOct 1999
- Primary completionApr 2000
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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 53 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
- NCT02249338
- Sponsor's protocol ID
- 543.10
- Status last verified
- Sep 2014
- First submitted
- 23 Sep 2014
- Last updated
- 26 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 14-Day Treatment With BIIL 284 BS on Patients With COPD (Double-Blind, Placebo-Controlled, Randomised, Parallel Group Study)
- ClinicalTrials.gov ID
- NCT02249338
- Acronym / sponsor ID
- 543.10
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 1999
- Primary completion
- Apr 2000 (actual)
- First posted
- 25 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 effect of 14-day treatment with BIIL 284 BS on sputum neutrophils and specific inflammatory markers in patients with clinically well-defined moderate chronic obstructive pulmonary disease (COPD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIL 284 BS | Experimental | Drug: BIIL 284 BS |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A diagnosis of COPD as defined by the American Thoracic Society criteria. Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 ≤ 70 % of predicted value and FEV1/FVC ≤ 70 % at Screening Visit 1
- Ability to produce an adequate induced sputum sample ad defined by: volume > 1 ml: squamous cells less than 80% and the ability to tolerate the procedure for at least four minutes with no bronchoconstriction ( a fall in FEV1 ≥ 20%)
- Greater than 50% of neutrophils in induced-sputum cells at visit 1. This requirement refers to the neutrophils percentage excluding squamous cells
- Males or females aged 40 to 80 years inclusive.
- Female patients of childbearing potential cannot participate in this study. Female patients participating in this study must meet at least one of the following criteria:
Key exclusion criteria (17 listed)
- Culture-documented and/or radiographic evidence and/or antibiotic treatment of an upper or lower respiratory tract infection within the previous 4 weeks or during the baseline period of this study
- Significant diseases other than COPD will be exclude. 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 inflammatory diseases e.g. rheumatoid arthritis, and those with autoimmune diseases will be excluded
- Clinically significant abnormal baseline haematology, liver function, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded. Laboratory parameters listed in the protocol must be within normal range, or if not, be documented by the investigator as not clinically relevant. The following tests may be outside the normal range to the extent indicated:
- A recent history (i.e. within six months) of myocardial infarction
- A recent history (i.e. within three months) of refractory heart failure or unstable arrhythmias requiring treatment
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 |
|---|---|---|
| BIIL 284 BS | Drug | BIIL 284 BS |
| Placebo | Drug | Placebo |
Primary outcome
Percentage of neutrophils in the induced sputum differential cell count
Time frame: Baseline, day 14
32 secondary outcomes
Percentage of neutrophils in the spontaneous sputum differential cell count
Time frame: Baseline, day 14
Percentage of neutrophils in the induced sputum differential cell count
Time frame: Baseline, day 28
Percentage of neutrophils in the spontaneous sputum differential cell count
Time frame: Baseline, day 28
Differential cell count in induced sputum
Time frame: Baseline, day 14 and 28
Differential cell count in spontaneous sputum
Time frame: Baseline, day 14 and 28
Wet weight of spontaneous sputum
Time frame: Day -6, 0, 6, 13 and 27
Concentration of myeloperoxidase (MPO) in induced sputum
Time frame: Baseline, day 14 and 28
Concentration of myeloperoxidase (MPO) in spontaneous sputum
Time frame: Baseline, day 14 and 28
Concentration of neutrophil elastase (NE) in induced sputum
Time frame: Baseline, day 14 and 28
Concentration of neutrophil elastase (NE) in spontaneous sputum
Time frame: Baseline, day 14 and 28
Concentration of interleukin-8 (IL-8) in induced sputum
Time frame: Baseline, day 14 and 28
Concentration of interleukin-8 (IL-8) in spontaneous sputum
Time frame: Baseline, day 14 and 28
Concentration of leukotriene B4 (LTB4) in induced sputum
Time frame: Baseline, day 14 and 28
Concentration of leukotriene B4 (LTB4) in spontaneous sputum
Time frame: Baseline, day 14 and 28
Concentration of albumin in induced sputum
Time frame: Baseline, day 14 and 28
Concentration of albumin in spontaneous sputum
Time frame: Baseline, day 14 and 28
Sputum bacterial load of induced sputum
Time frame: Baseline, day 14 and 28
Sputum bacterial load of spontaneous sputum
Time frame: Baseline, day 14 and 28
Sputum chemotactic activity of induced sputum
Time frame: Baseline, day 14 and 28
Sputum chemotactic activity of spontaneous sputum
Time frame: Baseline, day 14 and 28
Inhibition of blood neutrophil Mac-1 expression
Time frame: Day 1 and 14
Inhibition of blood neutrophil chemotaxis response to LTB4
Time frame: Day 1 and 14
Forced expiratory volume in one second (FEV1)
Time frame: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Forced vital capacity (FVC)
Time frame: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Forced expiratory flow (FEF25-75%)
Time frame: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Peak expiratory flow rate (PEFR)
Time frame: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Inspiratory capacity (IC)
Time frame: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Slow vital capacity (SVC)
Time frame: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Changes in COPD symptom score
Time frame: Baseline, Day 1, 7 and 14
Physician's global evaluation of symptoms assessed on a 4-point scale
Time frame: Baseline, Day 14
Number of patients with adverse events
Time frame: up to 6 weeks
Plasma concentrations of the analytes
Time frame: 30 min before, 90 and 240 min after drug administration on day 1 and 14
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 26 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 BIIL 284 BS 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 10 inclusion and 17 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 26 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?
Percentage of neutrophils in the induced sputum differential cell count (time frame: Baseline, day 14). 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 26 Sep 2014.