Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia
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|ClinicalTrials.gov Identifier: NCT00962481|
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : January 6, 2010
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Drug: Bimosiamose Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Active Comparator: Bimosiamose||
|Placebo Comparator: Placebo||
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962481
|Pneumologisches Forschungsinstitut GmbH am Krankenhaus Großhansdorf|
|Other Study ID Numbers:||
|First Posted:||August 20, 2009 Key Record Dates|
|Last Update Posted:||January 6, 2010|
|Last Verified:||January 2010|
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases