Pulmonary Disease, Chronic ObstructivePhase 2NCT02249247
Effect of Treatment With BIIL 284 BS on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Low dose of BIIL 284 BS tablets, Medium dose of BIIL 284 BS tablets and High dose of BIIL 284 BS tablets in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Study to investigate the effect of 12-week treatment with three doses (5, 25 and 75 mg) BIIL 284 BS on exercise endurance, lung function, quality of life, spontaneous sputum and safety in patients with 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?
- Low dose of BIIL 284 BS tablets, Medium dose of BIIL 284 BS tablets and High dose of BIIL 284 BS tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 577 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Aug 2002
- 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
- A diagnosis of COPD as defined by the American Thoracic Society (ATS) criteria. Patients had to have relatively stable airway obstruction with a FEV1 ≥ 20 % and ≤ 70 % of predicted value and FEV1/ FVC ≤ 70 % at screening Visit 1. Predicted normal values were based on the guidelines for standardised lung function testing of the European Community for Steel and Coal (ECSC) for patients of the Caucasian race and on the predicted equations for patients belonging to the Black race. Patients had to have lung hyperinflation as demonstrated by thoracic gas volume box (TGVbox) ≥ 100 % of predicted value (same as predicted value for functional residual capacity (FRC) measured by body plethysmography)
- Males or females aged 40 years or older. Female patients of childbearing potential could not participate in this study. Female patients had to be either:
- surgically sterilised by hysterectomy or bilateral tubal ligation, or
- post-menopausal for at least two years
- A smoking history of more than ten pack-years (p.y.). A p.y. was defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
- Patients had to be able to perform pulmonary function testings (PFTs), exercise endurance test not terminated due to leg discomfort alone or other restrictions diseases (e.g. claudicatio intermittens, etc.) only and maintain records during the study period as required in the protocol
- All patients had to sign both informed consent forms (one on specific study procedures, one related to DNA derived determinations) prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications if they agreed to participate in both portions of the trial. The patient was not obligated to participate in the DNA collection portion of the trial
Who cannot join
- Clinical and/or radiographic evidence and/or antibiotic treatment of an upper or lower respiratory tract infection within the previous four weeks or during the screening period of this study
- Significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator could either put the patient at risk because of participation in the study or a disease which could influence the results of the study or the patient's ability to participate in the study. Patients with inflammatory diseases, e.g., Rheumatoid Arthritis (RA), osteoarthritis, and those with autoimmune diseases were excluded
- Clinically significant abnormal baseline haematology, liver function, blood chemistry or urinalysis. If the abnormality defined a disease listed as an exclusion criterion the patient was excluded
- 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 arrhythmia requiring treatment
- Patients with known tuberculosis
Show all 14Show fewer
- A history of cancer within the last five years. Patients with treated basal cell carcinoma or cutaneous squamous cell carcinoma were allowed
- A history of life-threatening airway obstruction or a history of cystic fibrosis
- Previous thoracotomy with pulmonary resection. Patients with a history of a thoracotomy without pulmonary resection were evaluated as per exclusion criterion No. 2
- A change in pulmonary therapy, including rehabilitation therapy, within the four weeks prior to the first screening Visit (Visit 1) in order to control the patient's COPD
- A history of asthma or a total blood eosinophil count ≥ 600/mm3. A repeat eosinophil count was not conducted in these patients
- A history (within the past five years) 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 first Screening Visit (Visit 1)
- Patients requiring oxygen therapy 24 hours a day or requiring oxygen during exercise. Patients that desaturated during exercise were only excluded upon medical judgement of the investigator
About this study
Official title: Effect of 12-week Treatment of 5, 25 or 75 mg BIIL 284 BS on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (Double-blind, Double Dummy, Placebo-controlled, Randomized, Parallel Group, Dose Ranging Study)
Study to investigate the effect of 12-week treatment with three doses (5, 25 and 75 mg) BIIL 284 BS on exercise endurance, lung function, quality of life, spontaneous sputum and safety in patients with chronic obstructive pulmonary disease (COPD)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Low dose of BIIL 284 BS tablets, Medium dose of BIIL 284 BS tablets, High dose of BIIL 284 BS tablets, 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.
Low dose of BIIL 284 BS tabletsDrug
Medium dose of BIIL 284 BS tabletsDrug
High dose of BIIL 284 BS tabletsDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose of BIIL 284 BS | Experimental | Not described Receives: Drug: Low dose of BIIL 284 BS tablets |
| Medium dose of BIIL 284 BS | Experimental | Not described Receives: Drug: Medium dose of BIIL 284 BS tablets |
| High dose of BIIL 284 BS | Experimental | Not described Receives: Drug: High dose of BIIL 284 BS tablets |
| 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.
Changes in exercise endurance
evaluated by constant work load test
Measured: Pre-dose, up to 12 weeks after start of treatment
Secondary outcomes (23)
Changes in breathlessness during constant work load test
measured by Modified Borg scale: Dyspnea score, leg discomfort
Measured: Week 4 and week 12 weeks after start of treatment
Changes in forced expiratory volume in one second (FEV1)
assessed by spirometry
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in forced vital capacity (FVC)
assessed by spirometry
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in forced expiratory flow at 25%-75% of FVC (FEF25-75%)
assessed by spirometry
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in inspiratory capacity (IC)
assessed by spirometry
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in slow vital capacity (SVC)
assessed by spirometry
Measured: Pre-dose, up to 12 weeks after start of treatment
Change in thoracic gas volume
assessed by body plethysmography
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in total lung capacity
assessed by body plethysmography
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in residual volume
assessed by body plethysmography
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in specific airway conductance
assessed by body plethysmography
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in Mahler dyspnoea questionnaire
Baseline dyspnoea index / transitional dyspnoea index (BDI/TDI)
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in chronic respiratory disease questionnaire (CRDQ)
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in carbon monoxide diffusing capacity (DLco)
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in diffusing capacity of carbon monoxide corrected for alveolar volume (DLco/VA)
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in peak expiratory flow rate (PEFR) daily patient record
assessed a.m. and p.m. in daily patient record
Measured: Pre-dose, up to 14 weeks after start of treatment
Changes in 24-hours spontaneous sputum wet weight
Measured: Pre-dose, up 12 weeks after start of treatment
Changes in oxygen saturation during constant work load test
assessed by pulse oximetry
Measured: Pre-dose, up to 12 weeks after start of treatment
Changes in global evaluation assessed by investigator on a 4-point scale
Measured: Pre-dose, up to 14 weeks after start of treatment
Clinically relevant changes in vital signs (pulse rate, blood pressure)
Measured: Pre-dose, up to 14 weeks after start of treatment
Clinically relevant changes in ECG
Measured: Pre-dose, up to 14 weeks after start of treatment
Clinically relevant changes in laboratory tests
Measured: Pre-dose, up to 14 weeks after start of treatment
Number of patients with adverse events
Measured: Up to 17 weeks
Number of patients with acute COPD exacerbations
Measured: Up to 17 weeks
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 startApr 2001
- Primary completionAug 2002
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
- 577 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
- NCT02249247
- Sponsor's protocol ID
- 543.17
- 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 12-week Treatment of 5, 25 or 75 mg BIIL 284 BS on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (Double-blind, Double Dummy, Placebo-controlled, Randomized, Parallel Group, Dose Ranging Study)
- ClinicalTrials.gov ID
- NCT02249247
- Acronym / sponsor ID
- 543.17
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Aug 2002 (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 12-week treatment with three doses (5, 25 and 75 mg) BIIL 284 BS on exercise endurance, lung function, quality of life, spontaneous sputum and safety in patients with chronic obstructive pulmonary disease (COPD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose of BIIL 284 BS | Experimental | Drug: Low dose of BIIL 284 BS tablets |
| Medium dose of BIIL 284 BS | Experimental | Drug: Medium dose of BIIL 284 BS tablets |
| High dose of BIIL 284 BS | Experimental | Drug: High dose of BIIL 284 BS tablets |
| 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 (7 listed)
- A diagnosis of COPD as defined by the American Thoracic Society (ATS) criteria. Patients had to have relatively stable airway obstruction with a FEV1 ≥ 20 % and ≤ 70 % of predicted value and FEV1/ FVC ≤ 70 % at screening Visit 1. Predicted normal values were based on the guidelines for standardised lung function testing of the European Community for Steel and Coal (ECSC) for patients of the Caucasian race and on the predicted equations for patients belonging to the Black race. Patients had to have lung hyperinflation as demonstrated by thoracic gas volume box (TGVbox) ≥ 100 % of predicted value (same as predicted value for functional residual capacity (FRC) measured by body plethysmography)
- Males or females aged 40 years or older. Female patients of childbearing potential could not participate in this study. Female patients had to be either:
- A smoking history of more than ten pack-years (p.y.). A p.y. was defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
- Patients had to be able to perform pulmonary function testings (PFTs), exercise endurance test not terminated due to leg discomfort alone or other restrictions diseases (e.g. claudicatio intermittens, etc.) only and maintain records during the study period as required in the protocol
- All patients had to sign both informed consent forms (one on specific study procedures, one related to DNA derived determinations) prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications if they agreed to participate in both portions of the trial. The patient was not obligated to participate in the DNA collection portion of the trial
Key exclusion criteria (14 listed)
- Clinical and/or radiographic evidence and/or antibiotic treatment of an upper or lower respiratory tract infection within the previous four weeks or during the screening period of this study
- Significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator could either put the patient at risk because of participation in the study or a disease which could influence the results of the study or the patient's ability to participate in the study. Patients with inflammatory diseases, e.g., Rheumatoid Arthritis (RA), osteoarthritis, and those with autoimmune diseases were excluded
- Clinically significant abnormal baseline haematology, liver function, blood chemistry or urinalysis. If the abnormality defined a disease listed as an exclusion criterion the patient was excluded
- 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 arrhythmia 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 |
|---|---|---|
| Low dose of BIIL 284 BS tablets | Drug | Low dose of BIIL 284 BS |
| Medium dose of BIIL 284 BS tablets | Drug | Medium dose of BIIL 284 BS |
| High dose of BIIL 284 BS tablets | Drug | High dose of BIIL 284 BS |
| Placebo | Drug | Placebo |
Primary outcome
Changes in exercise endurance
Time frame: Pre-dose, up to 12 weeks after start of treatment
evaluated by constant work load test
23 secondary outcomes
Changes in breathlessness during constant work load test
Time frame: Week 4 and week 12 weeks after start of treatment
Changes in forced expiratory volume in one second (FEV1)
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in forced vital capacity (FVC)
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in forced expiratory flow at 25%-75% of FVC (FEF25-75%)
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in inspiratory capacity (IC)
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in slow vital capacity (SVC)
Time frame: Pre-dose, up to 12 weeks after start of treatment
Change in thoracic gas volume
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in total lung capacity
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in residual volume
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in specific airway conductance
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in Mahler dyspnoea questionnaire
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in chronic respiratory disease questionnaire (CRDQ)
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in carbon monoxide diffusing capacity (DLco)
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in diffusing capacity of carbon monoxide corrected for alveolar volume (DLco/VA)
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in peak expiratory flow rate (PEFR) daily patient record
Time frame: Pre-dose, up to 14 weeks after start of treatment
Changes in 24-hours spontaneous sputum wet weight
Time frame: Pre-dose, up 12 weeks after start of treatment
Changes in oxygen saturation during constant work load test
Time frame: Pre-dose, up to 12 weeks after start of treatment
Changes in global evaluation assessed by investigator on a 4-point scale
Time frame: Pre-dose, up to 14 weeks after start of treatment
Clinically relevant changes in vital signs (pulse rate, blood pressure)
Time frame: Pre-dose, up to 14 weeks after start of treatment
Clinically relevant changes in ECG
Time frame: Pre-dose, up to 14 weeks after start of treatment
Clinically relevant changes in laboratory tests
Time frame: Pre-dose, up to 14 weeks after start of treatment
Number of patients with adverse events
Time frame: Up to 17 weeks
Number of patients with acute COPD exacerbations
Time frame: Up to 17 weeks
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 Low dose of BIIL 284 BS tablets, Medium dose of BIIL 284 BS tablets and High dose of BIIL 284 BS tablets 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 7 inclusion and 14 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?
Changes in exercise endurance (time frame: Pre-dose, up to 12 weeks after start of treatment). 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.