Back to resultsSafety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients (CERA)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD1236
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
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
Sites / Locations
- Research Site
- Research Site
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- Research Site
- Research Site
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- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Adverse Events
Number of patients who had an Adverse Event
Secondary Outcome Measures
Forced Expiratory Volume in 1 Second (FEV1)
Change in FEV1 from baseline to end of treatment
Forced Vital Capacity (FVC)
Change in FVC from baseline to end of treatment
Vital Capacity (VC)
Change in VC from baseline to end of treatment
Inspiratory Capacity (IC)
Change in IC from baseline to end of treatment
Forced Expiratory Flow (FEF)25-75%
Change in FEF from baseline to end of treatment
Peak Expiratory Flow (PEF) Morning
Change in PEF from average during run-in to average during the last 4 w of treatment
Peak Expiratory Flow (PEF) Evening
Change in PEF from average during run-in to average during the last 4 w of 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)
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)
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)
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)
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)
6-minute Walk Test
Change from baseline to end of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00758459
Brief Title
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Acronym
CERA
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
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD1236
Intervention Description
oral tablet, 75 mg, twice daily during 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosing to match AZD1236
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
Number of patients who had an Adverse Event
Time Frame
all study visits
Secondary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 Second (FEV1)
Description
Change in FEV1 from baseline to end of treatment
Time Frame
Before treatment and after 1, 2, 4 and 6 weeks of treatment
Title
Forced Vital Capacity (FVC)
Description
Change in FVC from baseline to end of treatment
Time Frame
Before treatment and after 1, 2, 4 and 6 weeks of treatment
Title
Vital Capacity (VC)
Description
Change in VC from baseline to end of treatment
Time Frame
Before treatment and after 1, 2, 4 and 6 weeks of treatment
Title
Inspiratory Capacity (IC)
Description
Change in IC from baseline to end of treatment
Time Frame
Before treatment and after 1, 2, 4 and 6 weeks of treatment
Title
Forced Expiratory Flow (FEF)25-75%
Description
Change in FEF from baseline to end of treatment
Time Frame
Before treatment and after 1, 2, 4 and 6 weeks of treatment
Title
Peak Expiratory Flow (PEF) Morning
Description
Change in PEF from average during run-in to average during the last 4 w of treatment
Time Frame
Daily during run-in and treatment
Title
Peak Expiratory Flow (PEF) Evening
Description
Change in PEF from average during run-in to average during the last 4 w of treatment
Time Frame
Daily during run-in and treatment
Title
Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total
Description
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)
Time Frame
Before treatment and after 1, 2, 4 and 6 weeks of treatment
Title
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Description
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)
Time Frame
Daily during run-in and treatment
Title
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Description
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)
Time Frame
Daily during run-in and treatment
Title
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Description
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)
Time Frame
Daily during run-in and treatment
Title
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings
Description
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)
Time Frame
Daily during run-in and treatment
Title
6-minute Walk Test
Description
Change from baseline to end of treatment
Time Frame
Before treatment and after 6 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helgo Magnussen, MD, Professor
Organizational Affiliation
Pulmonary research institute at Hospital Grosshansdorf, Wöhrendamm, Grosshansdorf Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Lockton, MD
Organizational Affiliation
AstraZeneca R&D Charnwood
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Russe
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Oulu
Country
Finland
Facility Name
Research Site
City
Preitila
Country
Finland
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Grobhansdorf
Country
Germany
Facility Name
Research Site
City
Gyor
Country
Hungary
Facility Name
Research Site
City
Komlo
Country
Hungary
Facility Name
Research Site
City
Pecs
Country
Hungary
Facility Name
Research Site
City
Vasarosnameny
Country
Hungary
Facility Name
Research Site
City
Bojnice
Country
Slovakia
Facility Name
Research Site
City
Liptovsky Hradok
Country
Slovakia
Facility Name
Research Site
City
Zilina
Country
Slovakia
12. IPD Sharing Statement
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Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
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