Study to Evaluate Safety and Efficacy of Inhaled Bimosiamose for the Treatment of Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Multi-center, Randomized, Double-blind, Placebo-controlled, Cross-over Phase II Study to Evaluate the Safety and Efficacy of Inhaled Bimosiamose for the Treatment of Patients With Moderate to Severe COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108913
• Other study ID #: R015
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2010
• Last updated: May 6, 2011

Study information

• Verified date: May 2011
• 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 determine whether inhalation of Bimosiamose is safe and effective in the treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Male and postmenopausal or sterile female patients with a history of moderate to severe COPD defined as Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-III for at least 1 year

• At least 40 years of age

• Current smoker or ex-smoker with at least 10 pack-year smoking history (Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)

• Postbronchodilator FEV1 between 30% and 80% predicted and FEV1/FVC ratio < 70%. Postbronchodilator refers to 30 min after inhalation of 400 µg Salbutamol. This criterion for FEV1 will have to be demonstrated after a washout period of at least 48 h during which no long acting anticholinergic medication (LAMA) or long acting ß2-agonists (LABA) has been inhaled or a washout period of 6 h during which no short acting ß2-agonists (SABA) or anticholinergic medication (SAMA) has been inhaled. For patients having been pretreated with an inhaled corticosteroid (ICS) and/or theophylline, this criterion needs to be demonstrated after a washout of at least 4 weeks.

• Able to produce sputum upon induction in a sufficient quality. This criterion will be checked by the responsible sputum lab prior to randomization of the patient.

• Time and ability to complete the study

• Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.

Exclusion Criteria:

• Patients with a history of chronic respiratory disorders other than COPD e.g. asthma, a1-Antitrypsin deficiency, mucoviscidosis, lung fibrosis

• Patients who experienced an exacerbation in the 4 weeks before the screening visit or between screening and randomization

• Patients who experienced an acute upper respiratory tract infection or broncho-pulmonary infection requiring antibiotic treatment during the 4 weeks before the screening visit or between screening and randomization

• Treatment with inhaled (ICS), topical or any systemic corticosteroids or theophylline within at least 4 weeks before the screening visit and throughout entire course of the study. Patients with ICS and/or theophylline treatment will undergo a washout of at least 4 weeks after signature of the informed consent and prior to the screening visit, where eligibility to enter the study will be assessed

Study Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Bimosiamose

• Placebo

Locations

Country	Name	City	State
Germany	Insaf - Respiratory Research Institute GmbH	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Revotar Biopharmaceuticals AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in absolute neutrophil cell counts and interleukin-8 in induced sputum between Bimosiamose and placebo treatment