Clinical trial NCT00758706: A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ratio of TNF Alpha at Week 6 to Baseline
timeFrame: Baseline and Week 6
measure: Ratio of Sputum Total Cells at Week 6 to Baseline
timeFrame: Baseline and Week 6
measure: Ratio of Total Urine Desmosine at Week 6 to Baseline
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: all study visits
measure: Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Forced Vital Capacity (FVC) at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Vital Capacity (VC) at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Inspiratory Capacity (IC) at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment
timeFrame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
measure: Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment
timeFrame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
measure: Change From Baseline in Clinical COPD Questionnaire(CCQ) Total
timeFrame: Baseline and Week 6
measure: Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment
timeFrame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
measure: Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment
timeFrame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
measure: Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment
timeFrame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
measure: Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment
timeFrame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)
Other outcomes:
Locations:
city: Alborg
country: Denmark
facility: Research Site
city: Arhus C
country: Denmark
facility: Research Site
city: Kobenhavn Nv
country: Denmark
facility: Research Site
city: Odense C
country: Denmark
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
Study officials:
affiliation: Arhus Kommune HospitalMedicinsk
name: Ronald Dahl, MD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D Charnwood
name: Andrew Lockton, MD
role: STUDY_DIRECTOR
References: