A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients (BICO)

A Double-blind, Randomised, Placebo-controlled, Parallel Group Multi-centre Phase IIa Study to Assess the Effects on Biomarkers in Induced Sputum, Bood and Uine of AZD1236 Administered as Oral Tablet in Moderate to Severe COPD Patients During a 6 Week Period.

The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: AZD1236; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Alborg, Denmark
    • Research Site
  • Arhus C, Denmark
    • Research Site
  • Kobenhavn Nv, Denmark
    • Research Site
  • Odense C, Denmark
    • Research Site
• Finland
  • Helsinki, Finland
    • Research Site
  • Tampere, Finland
    • Research Site
• Netherlands
  • Eindhoven, Netherlands
    • Research Site
  • Nieuwegein, Netherlands
    • Research Site
• Norway
  • Oslo, Norway
    • Research Site
  • Trondheim, Norway
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of COPD for 1 month
• Men or postmenopausal women
• Spirometry values indicating symptomatic patients
• Smoking history equivalent to using 20 cigarettes a day for 10 years.

Exclusion Criteria:

• Any current respiratory tract disorders other than COPD
• Requirement for regular oxygen therapy
• Acute worsening of COPD (exacerbation) 1,5 month prior to study drug administration
• Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AZD1236; oral tablet, 75 mg, twice daily during 6 weeks	Drug: AZD1236; oral tablet, 75 mg, twice daily during 6 weeks
Placebo Comparator: Placebo; Dosing to match AZD1236	Drug: Placebo; Dosing to match AZD1236

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of TNF Alpha at Week 6 to Baseline	Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).	Baseline and Week 6
Ratio of Sputum Total Cells at Week 6 to Baseline	Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).	Baseline and Week 6
Ratio of Total Urine Desmosine at Week 6 to Baseline	Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.	Baseline and Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Number of patients who had an AE	all study visits
Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6	Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.	Baseline and Week 6
Change From Baseline in Forced Vital Capacity (FVC) at Week 6	Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.	Baseline and Week 6
Change From Baseline in Vital Capacity (VC) at Week 6	Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.	Baseline and Week 6
Change From Baseline in Inspiratory Capacity (IC) at Week 6	Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.	Baseline and Week 6
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Week 6	Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.	Baseline and Week 6
Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment	Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.	Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment	Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.	Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in Clinical COPD Questionnaire(CCQ) Total	Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)	Baseline and Week 6
Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment	Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).	Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment	Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).	Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment	Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).	Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment	Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).	Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Ronald Dahl, MD, Professor, Arhus Kommune HospitalMedicinsk; Study Director: Andrew Lockton, MD, AstraZeneca R&D Charnwood

Publications and helpful links

Helpful Links

• Related Info
• D4260C00007

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: September 23, 2008
• First Submitted That Met QC Criteria: September 23, 2008
• First Posted (Estimate): September 25, 2008

Study Record Updates

• Last Update Posted (Estimate): April 16, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D4260C00007