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

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2009

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Ratio of TNF Alpha at Week 6 to Baseline
    • Time Frame: Baseline and Week 6
    • 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
    • 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
    • Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.

Secondary Measures

  • Incidence of Adverse Events
    • Time Frame: all study visits
    • Number of patients who had an AE
  • Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6
    • Time Frame: Baseline and Week 6
    • 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
    • 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
    • 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
    • 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
    • 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)
    • 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)
    • 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
    • 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)
    • 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)
    • 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)
    • 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)
    • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ronald Dahl, MD, Professor, Principal Investigator, Arhus Kommune HospitalMedicinsk
    • Andrew Lockton, MD, Study Director, AstraZeneca R&D Charnwood

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