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Completed

NCT Number: NCT00962481

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pneumologisches Forschungsinstitut GmbH am Krankenhaus Großhansdorf

Großhansdorf, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Bimosiamose

Drug

Placebo

Drug

Sponsors and collaborators

Lead sponsor

Revotar Biopharmaceuticals AG

Industry

Registry information

Official study 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

Important dates

First posted
Aug 20, 2009
Registry last updated
Jan 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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