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:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00758706
First received: September 23, 2008
Last updated: July 15, 2009
Last verified: July 2009
  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:
  • Biomarkers in urine, blood and sputum [ Time Frame: As baseline and after 4 and 6 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nature and incidence of Adverse Events, vital signs and laboratory safety [ Time Frame: Throughout study, assessed at least at inclusion (run-in), randomisation (baseline) and after 1, 2, 4 and 6 weeks of treatment. Also after 1 week follow up. ] [ Designated as safety issue: No ]
  • Lung Function (Spirometry and PEF)Health status (COPD symptoms, rescue medication use, Clinical COPD questionnaire) [ Time Frame: At inclusion (run-in), randomisation (baseline) and after 1, 2, 4 and 6 weeks of treatment ] [ Designated as safety issue: No ]
  • Systemic exposure of AZD1236 [ Time Frame: After 2, 4 and 6 weeks of treatment. ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: September 2008
Study Completion Date: May 2009
Arms Assigned Interventions
Experimental: 1 Drug: AZD1236
oral tablet, 75 mg, twice daily during 6 weeks
Placebo Comparator: 2 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

No publications provided

Responsible Party: Andrew Lockton, MD, Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00758706     History of Changes
Other Study ID Numbers: D4260C00007
Study First Received: September 23, 2008
Last Updated: July 15, 2009
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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014