Chronic Obstructive Pulmonary DiseasePhase 2NCT01108913
Study to Evaluate Safety and Efficacy of Inhaled Bimosiamose for the Treatment of Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Bimosiamose in people with Chronic Obstructive Pulmonary Disease, run by Revotar Biopharmaceuticals AG at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether inhalation of Bimosiamose is safe and effective in the treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Bimosiamose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- 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
- Male and postmenopausal or sterile female patients with a history of moderate to severe COPD defined as Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-III for at least 1 year
- At least 40 years of age
- Current smoker or ex-smoker with at least 10 pack-year smoking history (Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- Postbronchodilator FEV1 between 30% and 80% predicted and FEV1/FVC ratio < 70%. Postbronchodilator refers to 30 min after inhalation of 400 µg Salbutamol. This criterion for FEV1 will have to be demonstrated after a washout period of at least 48 h during which no long acting anticholinergic medication (LAMA) or long acting β2-agonists (LABA) has been inhaled or a washout period of 6 h during which no short acting β2-agonists (SABA) or anticholinergic medication (SAMA) has been inhaled. For patients having been pretreated with an inhaled corticosteroid (ICS) and/or theophylline, this criterion needs to be demonstrated after a washout of at least 4 weeks.
- Able to produce sputum upon induction in a sufficient quality. This criterion will be checked by the responsible sputum lab prior to randomization of the patient.
- Time and ability to complete the study
- Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
Who cannot join
- Patients with a history of chronic respiratory disorders other than COPD e.g. asthma, α1-Antitrypsin deficiency, mucoviscidosis, lung fibrosis
- Patients who experienced an exacerbation in the 4 weeks before the screening visit or between screening and randomization
- Patients who experienced an acute upper respiratory tract infection or broncho-pulmonary infection requiring antibiotic treatment during the 4 weeks before the screening visit or between screening and randomization
- Treatment with inhaled (ICS), topical or any systemic corticosteroids or theophylline within at least 4 weeks before the screening visit and throughout entire course of the study. Patients with ICS and/or theophylline treatment will undergo a washout of at least 4 weeks after signature of the informed consent and prior to the screening visit, where eligibility to enter the study will be assessed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Randomized, Double-blind, Placebo-controlled, Cross-over Phase II Study to Evaluate the Safety and Efficacy of Inhaled Bimosiamose for the Treatment of Patients With Moderate to Severe COPD
The purpose of this study is to determine whether inhalation of Bimosiamose is safe and effective in the treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Bimosiamose, Placebo
- Keywords
- COPD
- 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.
BimosiamoseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Bimosiamose | Active comparator | Not described Receives: Drug: Bimosiamose |
| 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.
difference in absolute neutrophil cell counts and interleukin-8 in induced sputum between Bimosiamose and placebo treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Revotar Biopharmaceuticals AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108913
- Sponsor's protocol ID
- R015
- Status last verified
- May 2011
- First submitted
- 21 Apr 2010
- Last updated
- 9 May 2011
- Results posted
- No
Publications
Watz H, Bock D, Meyer M, Schierhorn K, Vollhardt K, Woischwill C, Pedersen F, Kirsten A, Beeh KM, Meyer-Sabellek W, Magnussen H, Beier J. Inhaled pan-selectin antagonist Bimosiamose attenuates airway inflammation in COPD. Pulm Pharmacol Ther. 2013 Apr;26(2):265-70. doi: 10.1016/j.pupt.2012.12.003. Epub 2012 Dec 17.
PubMed 23257347Kirsten A, Watz H, Kretschmar G, Pedersen F, Bock D, Meyer-Sabellek W, Magnussen H. Efficacy of the pan-selectin antagonist Bimosiamose on ozone-induced airway inflammation in healthy subjects--a double blind, randomized, placebo-controlled, cross-over clinical trial. Pulm Pharmacol Ther. 2011 Oct;24(5):555-8. doi: 10.1016/j.pupt.2011.04.029. Epub 2011 Apr 14.
PubMed 21514398
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double-blind, Placebo-controlled, Cross-over Phase II Study to Evaluate the Safety and Efficacy of Inhaled Bimosiamose for the Treatment of Patients With Moderate to Severe COPD
- ClinicalTrials.gov ID
- NCT01108913
- Acronym / sponsor ID
- R015
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Revotar Biopharmaceuticals AGIndustry (pharma, biotech, devices)
- First posted
- 22 Apr 2010 (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.
The purpose of this study is to determine whether inhalation of Bimosiamose is safe and effective in the treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimosiamose | Active comparator | Drug: Bimosiamose |
| 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)
- Male and postmenopausal or sterile female patients with a history of moderate to severe COPD defined as Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-III for at least 1 year
- At least 40 years of age
- Current smoker or ex-smoker with at least 10 pack-year smoking history (Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- Postbronchodilator FEV1 between 30% and 80% predicted and FEV1/FVC ratio < 70%. Postbronchodilator refers to 30 min after inhalation of 400 µg Salbutamol. This criterion for FEV1 will have to be demonstrated after a washout period of at least 48 h during which no long acting anticholinergic medication (LAMA) or long acting β2-agonists (LABA) has been inhaled or a washout period of 6 h during which no short acting β2-agonists (SABA) or anticholinergic medication (SAMA) has been inhaled. For patients having been pretreated with an inhaled corticosteroid (ICS) and/or theophylline, this criterion needs to be demonstrated after a washout of at least 4 weeks.
- Able to produce sputum upon induction in a sufficient quality. This criterion will be checked by the responsible sputum lab prior to randomization of the patient.
Key exclusion criteria (4 listed)
- Patients with a history of chronic respiratory disorders other than COPD e.g. asthma, α1-Antitrypsin deficiency, mucoviscidosis, lung fibrosis
- Patients who experienced an exacerbation in the 4 weeks before the screening visit or between screening and randomization
- Patients who experienced an acute upper respiratory tract infection or broncho-pulmonary infection requiring antibiotic treatment during the 4 weeks before the screening visit or between screening and randomization
- Treatment with inhaled (ICS), topical or any systemic corticosteroids or theophylline within at least 4 weeks before the screening visit and throughout entire course of the study. Patients with ICS and/or theophylline treatment will undergo a washout of at least 4 weeks after signature of the informed consent and prior to the screening visit, where eligibility to enter the study will be assessed
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 |
|---|---|---|
| Bimosiamose | Drug | Bimosiamose |
| Placebo | Drug | Placebo |
Primary outcome
difference in absolute neutrophil cell counts and interleukin-8 in induced sputum between Bimosiamose and placebo treatment
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 9 May 2011.
- Derived from this study: PubMed 23257347Watz H, Bock D, Meyer M, Schierhorn K, Vollhardt K, Woischwill C, Pedersen F, Kirsten A, Beeh KM, Meyer-Sabellek W, Magnussen H, Beier J. Inhaled pan-selectin antagonist Bimosiamose attenuates airway inflammation in COPD. Pulm Pharmacol Ther. 2013 Apr;26(2):265-70. doi: 10.1016/j.pupt.2012.12.003. Epub 2012 Dec 17.
- Derived from this study: PubMed 21514398Kirsten A, Watz H, Kretschmar G, Pedersen F, Bock D, Meyer-Sabellek W, Magnussen H. Efficacy of the pan-selectin antagonist Bimosiamose on ozone-induced airway inflammation in healthy subjects--a double blind, randomized, placebo-controlled, cross-over clinical trial. Pulm Pharmacol Ther. 2011 Oct;24(5):555-8. doi: 10.1016/j.pupt.2011.04.029. Epub 2011 Apr 14.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bimosiamose in people with Chronic Obstructive Pulmonary Disease, run by Revotar Biopharmaceuticals AG at 1 site in Germany.
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 4 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 9 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
difference in absolute neutrophil cell counts and interleukin-8 in induced sputum between Bimosiamose and placebo treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01108913, which also lists 2 linked publications.
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 9 May 2011.