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

This study has been completed.
Sponsor:
Information provided by:
Revotar Biopharmaceuticals AG
ClinicalTrials.gov Identifier:
NCT00962481
First received: August 19, 2009
Last updated: January 5, 2010
Last verified: January 2010

August 19, 2009
January 5, 2010
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Complete list of historical versions of study NCT00962481 on ClinicalTrials.gov Archive Site
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Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
  • Drug: Bimosiamose
  • Drug: Placebo
  • Active Comparator: Bimosiamose
    Intervention: Drug: Bimosiamose
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
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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).
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00962481
R014
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Revotar Biopharmaceuticals AG
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Revotar Biopharmaceuticals AG
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP