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:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00758706
First received: September 23, 2008
Last updated: July 15, 2009
Last verified: July 2009
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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
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 May 22, 2013