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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962481
First Posted: August 20, 2009
Last Update Posted: January 6, 2010
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.
Information provided by:
Revotar Biopharmaceuticals AG
  Purpose
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 Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Bimosiamose Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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 NLM:


Further study details as provided by Revotar Biopharmaceuticals AG:

Estimated Enrollment: 18
Arms Assigned Interventions
Active Comparator: Bimosiamose Drug: Bimosiamose
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00962481


Locations
Germany
Pneumologisches Forschungsinstitut GmbH am Krankenhaus Großhansdorf
Großhansdorf, Germany
Sponsors and Collaborators
Revotar Biopharmaceuticals AG
  More Information

ClinicalTrials.gov Identifier: NCT00962481     History of Changes
Other Study ID Numbers: R014
First Submitted: August 19, 2009
First Posted: August 20, 2009
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