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

NCT00962481 | Completed Phase 2

• 1 other identifier: R014
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Arms (2)

Bimosiamose

ACTIVE COMPARATOR

Drug: Bimosiamose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Bimosiamose DRUG

Bimosiamose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Revotar Biopharmaceuticals AG: lead

Study Sites (1)

Pneumologisches Forschungsinstitut GmbH am Krankenhaus Großhansdorf

Großhansdorf, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

bimosiamose

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Last Updated: January 6, 2010

Record last verified: 2010-01

Locations

DE (1)