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

AstraZeneca55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

AZD1236DRUG

oral tablet, 75 mg, twice daily during 6 weeks

PlaceboDRUG

Dosing to match AZD1236

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (10)

Research Site

Aalborg, Denmark

Research Site

Arhus C, Denmark

Research Site

København NV, Denmark

Research Site

Odense C, Denmark

Outcomes

Primary Outcomes

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).

Time frame: Baseline and Week 6

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).

Time frame: Baseline and Week 6

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.

Time frame: Baseline and Week 6

Secondary Outcomes

Incidence of Adverse Events

Number of patients who had an AE

Time frame: all study visits

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.

Time frame: Baseline and Week 6

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.

Time frame: Baseline and Week 6

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.

Data from ClinicalTrials.gov

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Research Site

Helsinki, Finland

Research Site

Tampere, Finland

Research Site

Eindhoven, Netherlands

Research Site

Nieuwegein, Netherlands

Research Site

Oslo, Norway

Research Site

Trondheim, Norway

Time frame: Baseline and Week 6

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.

Time frame: Baseline and Week 6

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.

Time frame: Baseline and Week 6

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.

Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

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.

Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

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)

Time frame: Baseline and Week 6

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).

Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

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)

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)

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)