Effect of BIIL 284 BS on Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02249338 | Completed Phase 2

• 1 other identifier: 543.10
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the effect of 14-day treatment with BIIL 284 BS on sputum neutrophils and specific inflammatory markers in patients with clinically well-defined moderate chronic obstructive pulmonary disease (COPD)

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Percentage of neutrophils in the induced sputum differential cell count

  Baseline, day 14

Secondary Outcomes (32)

• Percentage of neutrophils in the spontaneous sputum differential cell count

  Baseline, day 14

• Percentage of neutrophils in the induced sputum differential cell count

  Baseline, day 28

• Percentage of neutrophils in the spontaneous sputum differential cell count

  Baseline, day 28

• Differential cell count in induced sputum

  Baseline, day 14 and 28

• Differential cell count in spontaneous sputum

  Baseline, day 14 and 28

Study Arms (2)

BIIL 284 BS

EXPERIMENTAL

Drug: BIIL 284 BS

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIL 284 BS DRUG

BIIL 284 BS

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of COPD as defined by the American Thoracic Society criteria. Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 ≤ 70 % of predicted value and FEV1/FVC ≤ 70 % at Screening Visit 1
• Ability to produce an adequate induced sputum sample ad defined by: volume \> 1 ml: squamous cells less than 80% and the ability to tolerate the procedure for at least four minutes with no bronchoconstriction ( a fall in FEV1 ≥ 20%)
• Greater than 50% of neutrophils in induced-sputum cells at visit 1. This requirement refers to the neutrophils percentage excluding squamous cells
• Males or females aged 40 to 80 years inclusive.
• Female patients of childbearing potential cannot participate in this study. Female patients participating in this study must meet at least one of the following criteria:
• surgically sterilized by hysterectomy or bilateral tubal ligation
• post-menopausal for at least two years
• A smoking history of more than ten pack years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
• Patients must be able to perform pulmonary function tests and maintain records during the study period as required in the protocol
• All patients must sign an Informed Consent Form prior tho participation in the trial, i.e., prior to pre-study washout of their usual pulmonary medications

You may not qualify if:

• Culture-documented and/or radiographic evidence and/or antibiotic treatment of an upper or lower respiratory tract infection within the previous 4 weeks or during the baseline period of this study
• Significant diseases other than COPD will be exclude. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study. Patients with inflammatory diseases e.g. rheumatoid arthritis, and those with autoimmune diseases will be excluded
• Aspartate transaminase, Alanine transaminase, Total Bilirubin, Alkaline Phosphatase: 10% \> upper limit of normal (ULN)
• White blood cell count \< 3.80 x 10\*\*9/L, Neutrophils \< 2.00 x 10\*\*9/L, Platelets \< 100 x 10\*\*9/L, Hemoglobin \< 12 x g/dL
• Urea Nitrogen, Creatinine: 10% \> ULN
• A recent history (i.e. within six months) of myocardial infarction
• A recent history (i.e. within three months) of refractory heart failure or unstable arrhythmias requiring treatment
• Patients with known active tuberculosis
• A history of cancer within the last five years. Patients with treated basal cell carcinoma or cutaneous squamous cell carcinoma are allowed
• A history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
• The use of oral corticosteroids within 4 weeks, or theophyllines and oral or long-acting inhaled beta2-agonists within 2 weeks of visit 1
• A change in pulmonary therapy within the 6 weeks prior to the screening visit 1 in order to control the patient's COPD
• A history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600/mm\*\*3
• A history of and/or current alcohol abuse and/or drug abuse
• Use of an investigational drug within one month or six half-lives (which ever is greater) of the screening visit 1

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

amelubant

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: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 25, 2014
• Study Start: October 1, 1999
• Primary Completion: April 1, 2000
• Last Updated: September 26, 2014

Record last verified: 2014-09