Clinical trial NCT00758459: Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: A 6 Week Double-Blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of AZD1236as an Oral Tablet in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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: 74
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 tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD for 1 month
* Men or postmenopausal women
* Spirometry values indicating reduced lung function
* 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
* Use of oral or parenteral glucocorticosteroids within 30 days prior to the study

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: all study visits
Secondary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
measure: Forced Vital Capacity (FVC)
timeFrame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
measure: Vital Capacity (VC)
timeFrame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
measure: Inspiratory Capacity (IC)
timeFrame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
measure: Forced Expiratory Flow (FEF)25-75%
timeFrame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
measure: Peak Expiratory Flow (PEF) Morning
timeFrame: Daily during run-in and treatment
measure: Peak Expiratory Flow (PEF) Evening
timeFrame: Daily during run-in and treatment
measure: Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total
timeFrame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
measure: Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
timeFrame: Daily during run-in and treatment
measure: Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
timeFrame: Daily during run-in and treatment
measure: Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
timeFrame: Daily during run-in and treatment
measure: Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings
timeFrame: Daily during run-in and treatment
measure: 6-minute Walk Test
timeFrame: Before treatment and after 6 weeks of treatment
Other outcomes:
Locations:
city: Russe
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Preitila
country: Finland
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Grobhansdorf
country: Germany
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Komlo
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Vasarosnameny
country: Hungary
facility: Research Site
city: Bojnice
country: Slovakia
facility: Research Site
city: Liptovsky Hradok
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
Study officials:
affiliation: Pulmonary research institute at Hospital Grosshansdorf, Wöhrendamm, Grosshansdorf Germany
name: Helgo Magnussen, MD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D Charnwood
name: Andrew Lockton, MD
role: STUDY_DIRECTOR
References: