Back to resultsStudy to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Bimosiamose
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)
Eligibility Criteria
Inclusion Criteria:
- Able to produce sputum with normal sputum neutrophil levels at screening (< 65% of non-epithelial cells).
- Ozone responsive, defined as ≥ 20% relative increase in sputum neutrophils cell count after 3 h ozone challenge.
- At screening FEV1 at least 80% of predicted.
Exclusion Criteria:
- Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports of a recent tobacco use and/or who has a urine cotinine ≥ 500 ng/mL.
- Significant illness within two weeks prior to dosing (e.g., infection).
- Recent (within the last three years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
Sites / Locations
- Pneumologisches Forschungsinstitut GmbH am Krankenhaus Großhansdorf
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Bimosiamose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00962481
First Posted
August 19, 2009
Last Updated
January 5, 2010
Sponsor
Revotar Biopharmaceuticals AG
1. Study Identification
Unique Protocol Identification Number
NCT00962481
Brief Title
Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia
Official Title
A Double-blind, Placebo Controlled, Randomized, Cross-over, Phase IIa Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Revotar Biopharmaceuticals AG
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of repeated inhalative doses of Bimosiamose on ozone induced sputum neutrophilia in healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bimosiamose
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bimosiamose
Intervention Type
Drug
Intervention Name(s)
Placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Able to produce sputum with normal sputum neutrophil levels at screening (< 65% of non-epithelial cells).
Ozone responsive, defined as ≥ 20% relative increase in sputum neutrophils cell count after 3 h ozone challenge.
At screening FEV1 at least 80% of predicted.
Exclusion Criteria:
Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports of a recent tobacco use and/or who has a urine cotinine ≥ 500 ng/mL.
Significant illness within two weeks prior to dosing (e.g., infection).
Recent (within the last three years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
Facility Information:
Facility Name
Pneumologisches Forschungsinstitut GmbH am Krankenhaus Großhansdorf
City
Großhansdorf
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia
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