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)

AstraZeneca1 site in 1 country74 target enrollmentSeptember 2008

ConditionsChronic Obstructive Pulmonary Disease

InterventionsAZD1236 Placebo

DrugsAZD1236 Placebo

Overview

Phase: Phase 2
Intervention: AZD1236
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: AstraZeneca
Enrollment: 74
Locations: 1
Primary Endpoint: Incidence of Adverse Events
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

March 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

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

Arms & Interventions

1

Intervention: AZD1236

2

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of Adverse Events

Time Frame: all study visits

Number of patients who had an Adverse Event

Secondary Outcomes

Forced Expiratory Volume in 1 Second (FEV1)(Before treatment and after 1, 2, 4 and 6 weeks of treatment)
Forced Vital Capacity (FVC)(Before treatment and after 1, 2, 4 and 6 weeks of treatment)
Vital Capacity (VC)(Before treatment and after 1, 2, 4 and 6 weeks of treatment)
Inspiratory Capacity (IC)(Before treatment and after 1, 2, 4 and 6 weeks of treatment)
Forced Expiratory Flow (FEF)25-75%(Before treatment and after 1, 2, 4 and 6 weeks of treatment)
Peak Expiratory Flow (PEF) Morning(Daily during run-in and treatment)
Peak Expiratory Flow (PEF) Evening(Daily during run-in and treatment)
Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total(Before treatment and after 1, 2, 4 and 6 weeks of treatment)
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness(Daily during run-in and treatment)
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness(Daily during run-in and treatment)
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score(Daily during run-in and treatment)
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings(Daily during run-in and treatment)
6-minute Walk Test(Before treatment and after 6 weeks of treatment)