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 Chronic Obstructive Pulmonary Disease (COPD)

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 12.1Level: LLTClassification code 10010952Term: COPD

• Registration Number: EUCTR2009-017257-35-DE
• Lead Sponsor: Revotar Biopharmaceuticals AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-04
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Male and postmenopausal or sterile female patients with a history of moderate to severe COPD defined as 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
• Postbronchodilator FEV1 between 30 % and 80 % predicted and FEV1/FVC ratio < 70%. Postbronchodilator refers to 30 min after inhalation of 400 µg Salbutamol
• Able to produce sputum upon induction in a sufficient quality.
• 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with a history of chronic respiratory disorders other than COPD e.g. asthma, a1-Antitryspsin deficiency, mucoviscidosis, lung fibrosis
• Patients who experienced an exacerbation in the 4 weeks before the start of the study 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 start of the study or between screening and randomization
• Treatment with inhaled, topical or any systemic corticosteroids or theophylline within at least 4 weeks before screening and during the study period, patients on inhaled steroid and/or theophylline treatment will undergo a washout of at least 4 weeks prior to the screening visit after the informed consent has been signed
• Investigational drug within at least 4 weeks or at least 5 half-lives of investigational drug before study entry or during the study period whichever is longer and/or participation in another clinical trial within 4 weeks prior to Visit 1 and/or during the entire course of the study
• Treatment with systemic acting proteins and/or antibodies within at least 3 months before study entry or during the study period
• Previous treatment with Bimosiamose
• Known allergy to any of the components of Bimosiamose solution
• Patients with diagnosis/treatment of cancer and/or immunosuppressive therapy (according to ATC class L04; different washout for oral corticosteroids) within 5 past years
• Any condition which in the opinion of the investigator makes the patient unable to complete the study per protocol (e.g. patients not likely to stay in the study for 16 weeks because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable; or patients who have a concomitant condition that might confuse or confound study assessments)
• Patients with severe allergies manifested by a history of anaphylaxis or who have a history of multiple allergies
• Vaccination of any kind within 4 weeks prior to randomization and/or during the entire course of the study until completion of visit 8
• Presence or history of a major chronic inflammatory autoimmune disease like psoriasis, psoriatic arthritis, rheumatoid arthritis, spondyloarthropathy, inflammatory bowel disease or systemic lupus erythematosus (SLE)
• Positive result of HIV1/2 antibodies, HCV antibody or HBs antigen testing, evidence of acute Hepatitis A infection (anti-HAV-IgM positive)
• History of drug or alcohol abuse within the 12 months prior to dosing or alcohol breath test positive at screening or positive drug screening in urine
• gamma-GT=3 times the upper limit of normal
• Platelet count =10% below the lower limit of normal
• Patients who are known or suspected
- not to comply with the study directives
- not to be reliable or trustworthy
- not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
- to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in
• Patient is institutionalized because of legal or regulatory order
• Re-entry of a patient who has been randomized already in this trial
• Employee at the investigational site, relative or spouse of the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified