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

Chronic Obstructive Pulmonary Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758706
• Other study ID #: D4260C00007
• Status: Completed
• Phase: Phase 2
• First received: September 23, 2008
• Last updated: April 14, 2015
• Start date: September 2008
• Est. completion date: May 2009

Study information

• Verified date: April 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD1236
oral tablet, 75 mg, twice daily during 6 weeks
• Placebo
Dosing to match AZD1236

Locations

Country	Name	City	State
Denmark	Research Site	Alborg
Denmark	Research Site	Arhus C
Denmark	Research Site	Kobenhavn Nv
Denmark	Research Site	Odense C
Finland	Research Site	Helsinki
Finland	Research Site	Tampere
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Nieuwegein
Norway	Research Site	Oslo
Norway	Research Site	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Finland,  Netherlands,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Incidence of Adverse Events	Number of patients who had an AE	all study visits	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No

External Links

•   Link
•   D4260C00007