Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00962481
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : January 6, 2010
Information provided by:
Revotar Biopharmaceuticals AG

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.

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ozone
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Bimosiamose Drug: Bimosiamose
Placebo Comparator: Placebo Drug: Placebo

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT00962481

Pneumologisches Forschungsinstitut GmbH am Krankenhaus Großhansdorf
Großhansdorf, Germany
Sponsors and Collaborators
Revotar Biopharmaceuticals AG Identifier: NCT00962481     History of Changes
Other Study ID Numbers: R014
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: January 6, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases