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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00758706
First received: September 23, 2008
Last updated: April 14, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: AZD1236
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Ratio of TNF Alpha at Week 6 to Baseline [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: all study visits ] [ Designated as safety issue: No ]
    Number of patients who had an AE

  • Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6) ] [ Designated as safety issue: No ]
    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).


Enrollment: 55
Study Start Date: September 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758706

Locations
Denmark
Research Site
Alborg, Denmark
Research Site
Arhus C, Denmark
Research Site
Kobenhavn Nv, Denmark
Research Site
Odense C, Denmark
Finland
Research Site
Helsinki, Finland
Research Site
Tampere, Finland
Netherlands
Research Site
Eindhoven, Netherlands
Research Site
Nieuwegein, Netherlands
Norway
Research Site
Oslo, Norway
Research Site
Trondheim, Norway
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Ronald Dahl, MD, Professor Arhus Kommune HospitalMedicinsk
Study Director: Andrew Lockton, MD AstraZeneca R&D Charnwood
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00758706     History of Changes
Other Study ID Numbers: D4260C00007
Study First Received: September 23, 2008
Results First Received: July 25, 2011
Last Updated: April 14, 2015
Health Authority: Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency

Keywords provided by AstraZeneca:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 29, 2015