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

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ClinicalTrials.gov Identifier: NCT00758459
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : August 19, 2011
Last Update Posted : August 19, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: AZD1236 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: all study visits ]
    Number of patients who had an Adverse Event


Secondary Outcome Measures :
  1. Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ]
    Change in FEV1 from baseline to end of treatment

  2. Forced Vital Capacity (FVC) [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ]
    Change in FVC from baseline to end of treatment

  3. Vital Capacity (VC) [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ]
    Change in VC from baseline to end of treatment

  4. Inspiratory Capacity (IC) [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ]
    Change in IC from baseline to end of treatment

  5. Forced Expiratory Flow (FEF)25-75% [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ]
    Change in FEF from baseline to end of treatment

  6. Peak Expiratory Flow (PEF) Morning [ Time Frame: Daily during run-in and treatment ]
    Change in PEF from average during run-in to average during the last 4 w of treatment

  7. Peak Expiratory Flow (PEF) Evening [ Time Frame: Daily during run-in and treatment ]
    Change in PEF from average during run-in to average during the last 4 w of treatment

  8. Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ]
    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)

  9. Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness [ Time Frame: Daily during run-in and treatment ]
    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)

  10. Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness [ Time Frame: Daily during run-in and treatment ]
    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)

  11. Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score [ Time Frame: Daily during run-in and treatment ]
    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)

  12. Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings [ Time Frame: Daily during run-in and treatment ]
    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)

  13. 6-minute Walk Test [ Time Frame: Before treatment and after 6 weeks of treatment ]
    Change from baseline to end of treatment


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758459


Locations
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Bulgaria
Research Site
Russe, Bulgaria
Research Site
Sofia, Bulgaria
Finland
Research Site
Helsinki, Finland
Research Site
Oulu, Finland
Research Site
Preitila, Finland
Germany
Research Site
Berlin, Germany
Research Site
Grobhansdorf, Germany
Hungary
Research Site
Gyor, Hungary
Research Site
Komlo, Hungary
Research Site
Pecs, Hungary
Research Site
Vasarosnameny, Hungary
Slovakia
Research Site
Bojnice, Slovakia
Research Site
Liptovsky Hradok, Slovakia
Research Site
Zilina, Slovakia
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Helgo Magnussen, MD, Professor Pulmonary research institute at Hospital Grosshansdorf, Wöhrendamm, Grosshansdorf Germany
Study Director: Andrew Lockton, MD AstraZeneca R&D Charnwood
More Information
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Responsible Party: Andrew Lockton, MD, Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00758459    
Other Study ID Numbers: D4260C00003
First Posted: September 25, 2008    Key Record Dates
Results First Posted: August 19, 2011
Last Update Posted: August 19, 2011
Last Verified: July 2011
Keywords provided by AstraZeneca:
COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases