Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients (CERA)

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: AZD1236; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Russe, Bulgaria
    • Research Site
  • Sofia, Bulgaria
    • Research Site
• Finland
  • Helsinki, Finland
    • Research Site
  • Oulu, Finland
    • Research Site
  • Preitila, Finland
    • Research Site
• Germany
  • Berlin, Germany
    • Research Site
  • Grobhansdorf, Germany
    • Research Site
• Hungary
  • Gyor, Hungary
    • Research Site
  • Komlo, Hungary
    • Research Site
  • Pecs, Hungary
    • Research Site
  • Vasarosnameny, Hungary
    • Research Site
• Slovakia
  • Bojnice, Slovakia
    • Research Site
  • Liptovsky Hradok, Slovakia
    • Research Site
  • Zilina, Slovakia
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD1236; oral tablet, 75 mg, twice daily during 6 weeks
Placebo Comparator: 2	Drug: Placebo; Dosing to match AZD1236

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Number of patients who had an Adverse Event	all study visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in 1 Second (FEV1)	Change in FEV1 from baseline to end of treatment	Before treatment and after 1, 2, 4 and 6 weeks of treatment
Forced Vital Capacity (FVC)	Change in FVC from baseline to end of treatment	Before treatment and after 1, 2, 4 and 6 weeks of treatment
Vital Capacity (VC)	Change in VC from baseline to end of treatment	Before treatment and after 1, 2, 4 and 6 weeks of treatment
Inspiratory Capacity (IC)	Change in IC from baseline to end of treatment	Before treatment and after 1, 2, 4 and 6 weeks of treatment
Forced Expiratory Flow (FEF)25-75%	Change in FEF from baseline to end of treatment	Before treatment and after 1, 2, 4 and 6 weeks of treatment
Peak Expiratory Flow (PEF) Morning	Change in PEF from average during run-in to average during the last 4 w of treatment	Daily during run-in and treatment
Peak Expiratory Flow (PEF) Evening	Change in PEF from average during run-in to average during the last 4 w of treatment	Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total	Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)	Before treatment and after 1, 2, 4 and 6 weeks of treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness	Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)	Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness	Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)	Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score	Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)	Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings	Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)	Daily during run-in and treatment
6-minute Walk Test	Change from baseline to end of treatment	Before treatment and after 6 weeks of treatment

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Andrew Lockton, MD, AstraZeneca R&D Charnwood; Principal Investigator: Helgo Magnussen, MD, Professor, Pulmonary research institute at Hospital Grosshansdorf, Wöhrendamm, Grosshansdorf Germany

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: September 23, 2008
• First Submitted That Met QC Criteria: September 23, 2008
• First Posted (Estimate): September 25, 2008

Study Record Updates

• Last Update Posted (Estimate): August 19, 2011
• Last Update Submitted That Met QC Criteria: July 25, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D4260C00003