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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Ratio of TNF Alpha at Week 6 to Baseline
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AZD1236
oral tablet, 75 mg, twice daily during 6 weeks
Intervention: AZD1236 (Drug)
Placebo
Dosing to match AZD1236
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Incidence of Adverse Events(all study visits)
- Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6(Baseline and Week 6)
- Change From Baseline in Forced Vital Capacity (FVC) at Week 6(Baseline and Week 6)
- Change From Baseline in Vital Capacity (VC) at Week 6(Baseline and Week 6)
- Change From Baseline in Inspiratory Capacity (IC) at Week 6(Baseline and Week 6)
- Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Week 6(Baseline and Week 6)
- Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment(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(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(Baseline and Week 6)
- Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment(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(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(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(Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6))