Back to resultsA Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients (BICO)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD1236
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
Eligibility Criteria
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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AZD1236
Placebo
Arm Description
oral tablet, 75 mg, twice daily during 6 weeks
Dosing to match AZD1236
Outcomes
Primary Outcome Measures
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).
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).
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.
Secondary Outcome Measures
Incidence of Adverse Events
Number of patients who had an AE
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.
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.
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.
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.
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.
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.
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.
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)
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00758706
Brief Title
A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients
Acronym
BICO
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD1236
Arm Type
Experimental
Arm Description
oral tablet, 75 mg, twice daily during 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dosing to match AZD1236
Intervention Type
Drug
Intervention Name(s)
AZD1236
Intervention Description
oral tablet, 75 mg, twice daily during 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosing to match AZD1236
Primary Outcome Measure Information:
Title
Ratio of TNF Alpha at Week 6 to Baseline
Description
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).
Time Frame
Baseline and Week 6
Title
Ratio of Sputum Total Cells at Week 6 to Baseline
Description
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).
Time Frame
Baseline and Week 6
Title
Ratio of Total Urine Desmosine at Week 6 to Baseline
Description
Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.
Time Frame
Baseline and Week 6
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
Number of patients who had an AE
Time Frame
all study visits
Title
Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6
Description
Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.
Time Frame
Baseline and Week 6
Title
Change From Baseline in Forced Vital Capacity (FVC) at Week 6
Description
Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.
Time Frame
Baseline and Week 6
Title
Change From Baseline in Vital Capacity (VC) at Week 6
Description
Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.
Time Frame
Baseline and Week 6
Title
Change From Baseline in Inspiratory Capacity (IC) at Week 6
Description
Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.
Time Frame
Baseline and Week 6
Title
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Week 6
Description
Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.
Time Frame
Baseline and Week 6
Title
Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment
Description
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.
Time Frame
Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Title
Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment
Description
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.
Time Frame
Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Title
Change From Baseline in Clinical COPD Questionnaire(CCQ) Total
Description
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)
Time Frame
Baseline and Week 6
Title
Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment
Description
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).
Time Frame
Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Title
Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment
Description
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).
Time Frame
Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Title
Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment
Description
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).
Time Frame
Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Title
Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment
Description
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).
Time Frame
Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Dahl, MD, Professor
Organizational Affiliation
Arhus Kommune HospitalMedicinsk
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Lockton, MD
Organizational Affiliation
AstraZeneca R&D Charnwood
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Alborg
Country
Denmark
Facility Name
Research Site
City
Arhus C
Country
Denmark
Facility Name
Research Site
City
Kobenhavn Nv
Country
Denmark
Facility Name
Research Site
City
Odense C
Country
Denmark
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Tampere
Country
Finland
Facility Name
Research Site
City
Eindhoven
Country
Netherlands
Facility Name
Research Site
City
Nieuwegein
Country
Netherlands
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=360&filename=CSR-D4260C00007.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=360&filename=CSR-D4260C00007.pdf
Description
D4260C00007
Learn more about this trial
A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients
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