Effect of Treatment With BIIL 284 BS on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease

NCT02249247 | Completed Phase 2

• 1 other identifier: 543.17
• Study Type: interventional
• Target: 577
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the effect of 12-week treatment with three doses (5, 25 and 75 mg) BIIL 284 BS on exercise endurance, lung function, quality of life, spontaneous sputum and safety in patients with chronic obstructive pulmonary disease (COPD)

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Changes in exercise endurance

  evaluated by constant work load test

  Pre-dose, up to 12 weeks after start of treatment

Secondary Outcomes (23)

• Changes in breathlessness during constant work load test

  Week 4 and week 12 weeks after start of treatment

• Changes in forced expiratory volume in one second (FEV1)

  Pre-dose, up to 12 weeks after start of treatment

• Changes in forced vital capacity (FVC)

  Pre-dose, up to 12 weeks after start of treatment

• Changes in forced expiratory flow at 25%-75% of FVC (FEF25-75%)

  Pre-dose, up to 12 weeks after start of treatment

• Changes in inspiratory capacity (IC)

  Pre-dose, up to 12 weeks after start of treatment

Study Arms (4)

Low dose of BIIL 284 BS

EXPERIMENTAL

Drug: Low dose of BIIL 284 BS tablets

Medium dose of BIIL 284 BS

EXPERIMENTAL

Drug: Medium dose of BIIL 284 BS tablets

High dose of BIIL 284 BS

EXPERIMENTAL

Drug: High dose of BIIL 284 BS tablets

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Low dose of BIIL 284 BS tablets DRUG

Low dose of BIIL 284 BS

Medium dose of BIIL 284 BS tablets DRUG

Medium dose of BIIL 284 BS

High dose of BIIL 284 BS tablets DRUG

High dose of BIIL 284 BS

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 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 (ATS) criteria. Patients had to have relatively stable airway obstruction with a FEV1 ≥ 20 % and ≤ 70 % of predicted value and FEV1/ FVC ≤ 70 % at screening Visit 1. Predicted normal values were based on the guidelines for standardised lung function testing of the European Community for Steel and Coal (ECSC) for patients of the Caucasian race and on the predicted equations for patients belonging to the Black race. Patients had to have lung hyperinflation as demonstrated by thoracic gas volume box (TGVbox) ≥ 100 % of predicted value (same as predicted value for functional residual capacity (FRC) measured by body plethysmography)
• Males or females aged 40 years or older. Female patients of childbearing potential could not participate in this study. Female patients had to be either:
• surgically sterilised by hysterectomy or bilateral tubal ligation, or
• post-menopausal for at least two years
• A smoking history of more than ten pack-years (p.y.). A p.y. was defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
• Patients had to be able to perform pulmonary function testings (PFTs), exercise endurance test not terminated due to leg discomfort alone or other restrictions diseases (e.g. claudicatio intermittens, etc.) only and maintain records during the study period as required in the protocol
• All patients had to sign both informed consent forms (one on specific study procedures, one related to DNA derived determinations) prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications if they agreed to participate in both portions of the trial. The patient was not obligated to participate in the DNA collection portion of the trial

You may not qualify if:

• Clinical and/or radiographic evidence and/or antibiotic treatment of an upper or lower respiratory tract infection within the previous four weeks or during the screening period of this study
• Significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator could either put the patient at risk because of participation in the study or a disease which could influence the results of the study or the patient's ability to participate in the study. Patients with inflammatory diseases, e.g., Rheumatoid Arthritis (RA), osteoarthritis, and those with autoimmune diseases were excluded
• 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 arrhythmia requiring treatment
• Patients with known tuberculosis
• A history of cancer within the last five years. Patients with treated basal cell carcinoma or cutaneous squamous cell carcinoma were allowed
• A history of life-threatening airway obstruction or a history of cystic fibrosis
• A change in pulmonary therapy, including rehabilitation therapy, within the four weeks prior to the first screening Visit (Visit 1) in order to control the patient's COPD
• A history of asthma or a total blood eosinophil count ≥ 600/mm3. A repeat eosinophil count was not conducted in these patients
• A history (within the past five years) 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 first Screening Visit (Visit 1)
• Patients requiring oxygen therapy 24 hours a day or requiring oxygen during exercise. Patients that desaturated during exercise were only excluded upon medical judgement of the investigator

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: April 1, 2001
• Primary Completion: August 1, 2002
• Last Updated: September 26, 2014

Record last verified: 2014-09