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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Placebo; Drug: AZD1236

• Registration Number: NCT00758706
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2011-07-25
• Status Verified: 2015-04
• Results First Submitted QC: 2015-04-14
• Last Update Submitted: 2015-04-14
• Results First Posted: 2015-04-16
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Dosing to match AZD1236
AZD1236	AZD1236	oral tablet, 75 mg, twice daily during 6 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇳🇴 Trondheim, Norway