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

September 23, 2008
July 25, 2011
September 2008
Not Provided
Incidence of Adverse Events [ Time Frame: all study visits ] [ Designated as safety issue: Yes ]
Number of patients who had an Adverse Event
  • Nature and incidence of Adverse Events [ Time Frame: Throughout study, assessed at least at inclusion (run-in), randomisation (baseline) and after 1, 2, 4 and 6 weeks of treatment. Also after 1 week follow up. ] [ Designated as safety issue: Yes ]
  • Vital signs and laboratory safety assessments [ Time Frame: At inclusion (run-in), randomisation (baseline) and after 1, 2, 4 and 6 weeks of treatment. Also after 1 week follow up. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00758459 on ClinicalTrials.gov Archive Site
  • 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
  • Lung Function (Spirometry and PEF)Health status (COPD symptoms, rescue medication use, Clinical COPD questionnaire) [ Time Frame: At inclusion (run-in), randomisation (baseline) and after 1, 2, 4 and 6 weeks of treatment ] [ Designated as safety issue: No ]
  • Systemic exposure of AZD1236 [ Time Frame: After 2, 4 and 6 weeks of treatment. ] [ Designated as safety issue: Yes ]
  • Biomarkers in blood and urine [ Time Frame: At randomisation (baseline) and after 4 and 6 weeks of treatment. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: AZD1236
    oral tablet, 75 mg, twice daily during 6 weeks
  • Drug: Placebo
    Dosing to match AZD1236
  • Experimental: 1
    Intervention: Drug: AZD1236
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
March 2009
Not Provided

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Finland,   Germany,   Hungary,   Slovakia
 
NCT00758459
D4260C00003
No
Andrew Lockton, MD, Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Principal Investigator: Helgo Magnussen, MD, Professor Pulmonary research institute at Hospital Grosshansdorf, Wöhrendamm, Grosshansdorf Germany
Study Director: Andrew Lockton, MD AstraZeneca R&D Charnwood
AstraZeneca
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP