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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962481

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

No publications provided

ClinicalTrials.gov Identifier: NCT00962481     History of Changes
Other Study ID Numbers: R014
Study First Received: August 19, 2009
Last Updated: January 5, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 23, 2013