Text Size

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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00758459
First received: September 23, 2008
Last updated: July 25, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: AZD1236
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: all study visits ] [ Designated as safety issue: Yes ]
    Number of patients who had an Adverse Event


Secondary Outcome Measures:
  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ] [ Designated as safety issue: No ]
    Change in FEV1 from baseline to end of treatment

  • Forced Vital Capacity (FVC) [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ] [ Designated as safety issue: No ]
    Change in FVC from baseline to end of treatment

  • Vital Capacity (VC) [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ] [ Designated as safety issue: No ]
    Change in VC from baseline to end of treatment

  • Inspiratory Capacity (IC) [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ] [ Designated as safety issue: No ]
    Change in IC from baseline to end of treatment

  • Forced Expiratory Flow (FEF)25−75% [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ] [ Designated as safety issue: No ]
    Change in FEF from baseline to end of treatment

  • Peak Expiratory Flow (PEF) Morning [ Time Frame: Daily during run-in and treatment ] [ Designated as safety issue: No ]
    Change in PEF from average during run-in to average during the last 4 w of treatment

  • Peak Expiratory Flow (PEF) Evening [ Time Frame: Daily during run-in and treatment      ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in and treatment      ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in and treatment      ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in and treatment      ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in and treatment      ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before treatment and after 6 weeks of treatment ] [ Designated as safety issue: No ]
    Change from baseline to end of treatment


Enrollment: 74
Study Start Date: September 2008
Study Completion Date: March 2009
Arms Assigned Interventions
Experimental: 1 Drug: AZD1236
oral tablet, 75 mg, twice daily during 6 weeks
Placebo Comparator: 2 Drug: Placebo
Dosing to match AZD1236

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758459

Locations
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
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

No publications provided

Responsible Party: Andrew Lockton, MD, Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00758459     History of Changes
Other Study ID Numbers: D4260C00003
Study First Received: September 23, 2008
Results First Received: July 25, 2011
Last Updated: July 25, 2011
Health Authority: Bulgaria: Bulgarian Drug Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Slovakia: State Institute for Drug Control

Keywords provided by AstraZeneca:
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013