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Completed

NCT Number: NCT00758459

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Rousse, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1236

Drug

oral tablet, 75 mg, twice daily during 6 weeks

Placebo

Drug

Dosing to match AZD1236

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: all study visits

    Number of patients who had an Adverse Event

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: CERA

Important dates

Study start
2008
Study completion
2009
First posted
Sep 25, 2008
Registry last updated
Aug 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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