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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962481
• Other study ID #: R014
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2009
• Last updated: January 5, 2010

Study information

• Verified date: January 2010
• Source: Revotar Biopharmaceuticals AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Bimosiamose

• Placebo

Locations

Country	Name	City	State
Germany	Pneumologisches Forschungsinstitut GmbH am Krankenhaus Großhansdorf	Großhansdorf

Sponsors (1)

Lead Sponsor	Collaborator
Revotar Biopharmaceuticals AG

Country where clinical trial is conducted

Germany,