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OpenTrials
Completed

NCT Number: NCT01153321

Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)

The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Hanover, Hannover, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
  • ≥ 40 years of age at Visit 1
  • Clinical diagnosis of COPD (GOLD stage 1)
  • FEV1 ≥ 80% of the predicted normal post-bronchodilator at Visit 1 (GOLD stage 1)
  • FEV1/FVC <70% post-bronchodilator at Visit 1 (GOLD stage 1)

Exclusion criteria

  • Any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
  • Any clinically relevant abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability or take part or influence the results of the study
  • A past history or current indication of renal (kidney) failure
  • Subjects at risk of active tuberculosis or of disease reactivation
  • Subjects who have had any clinically significant illness within 4 weeks before Visit 2 (start of treatment)

Treatment and study plan

AZD2423

Drug

100mg Oral dose od

AZD2423 Placebo

Drug

Oral dose od

Primary outcomes

  1. Absolute Monocyte Count in BAL Post-LPS Challenge

    Time frame: Day 11

    Monocyte count in BAL post-LPS challenge (Day 11)

Secondary outcomes

  1. Total Neutrophils in Biopsy Sample (Post-LPS Challenge)

    Time frame: Day 11

    Pre-challenge = Day 11. Biopsies taken from left lingula. Cells counted in subepithelium.

  2. Total Macrophages in Biopsy Sample (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.

  3. CD45+ in Biopsy Sample (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.

  4. CD3+ in Biopsy Sample (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.

  5. Biopsy PAS Reaction Grade (Post-LPS Challenge)

    Time frame: Day 11

    Biopsies stained using PAS method. Graded on subjective scale (1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells).

  6. Biopsy Epithelium Grade (Post-LPS Challenge)

    Time frame: Day 11

    Biopsies (from right middle lobe) were assessed for routine histopathology. Epithelial morphology was graded on subjective scale from 1 to 5. 1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells

  7. Eosinophils in BAL (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge eosinophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.

  8. Lymphocytes in BAL (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge lymphocyte differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.

  9. Neutrophils in BAL (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge neutrophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.

  10. Macrophages in BAL (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge macrophage differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.

  11. TNF α Concentration in BAL (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge TNF α concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

  12. CCL2 Concentration in BAL (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge CCL2 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

  13. IL-1β Concentration in BAL (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge IL-1β concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

  14. IL-6 Concentration in BAL (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge IL-6 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

  15. IL-8 Concentration in BAL (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge IL 8 concentration in BAL. LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

  16. RANTES Concentration in BAL (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge RANTES concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

  17. SP-D Concentration in BAL (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge SP-D concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

  18. SAA Concentration in Blood (Pre-LPS Challenge)

    Time frame: Day 10

    SAA concentration in blood pre-LPS challenge (Day 10).

  19. SAA Concentration in Blood (Post-LPS Challenge)

    Time frame: Day 11

    SAA concentration in blood post-LPS challenge (Day 11)

  20. CCL2 Concentration in Blood (Pre-LPS Challenge)

    Time frame: Day 10

    CCL2 concentration in blood pre-LPS challenge (Day 10)

  21. CCL2 Concentration in Blood (Post-LPS Challenge)

    Time frame: Day 11

    CCL2 concentration in blood post-LPS challenge (Day 11).

  22. IL-1β Concentration in Blood (Pre-LPS Challenge)

    Time frame: Day 10

    IL-1β concentration in blood pre-LPS challenge (Day 10)

  23. IL-1β Concentration in Blood (Post-LPS Challenge)

    Time frame: Day 11

    IL-1β concentration in blood post-LPS challenge (Day 11)

  24. IL-6 Concentration in Blood (Pre-LPS Challenge)

    Time frame: Day 10

    IL-6 concentration in blood pre-LPS challenge (Day 10)

  25. IL-6 Concentration in Blood (Post-LPS Challenge)

    Time frame: Day 11

    IL-6 concentration in blood post-LPS challenge (Day 11)

  26. IL-8 Concentration in Blood (Pre-LPS Challenge)

    Time frame: Day 10

    IL-8 concentration in blood pre-LPS challenge (Day 10)

  27. IL-8 Concentration in Blood (Post-LPS Challenge)

    Time frame: day 11

    IL-8 concentration in blood post-LPS challenge (Day 11)

  28. TNF-α Concentration in Blood (Pre-LPS Challenge)

    Time frame: Day 10

    TNF-α concentration in blood pre-LPS challenge (Day 10)

  29. TNF-α Concentration in Blood (Post-LPS Challenge)

    Time frame: Day 11

    TNF-α concentration in blood post-LPS challenge (Day 11)

  30. SP-D Concentration in Blood (Pre-LPS Challenge)

    Time frame: Day 10

    SP-D concentration in blood pre-LPS challenge (Day 10)

  31. SP-D Concentration in Blood (Post-LPS Challenge)

    Time frame: Day 11

    SP-D concentration in blood post-LPS challenge (Day 11)

  32. CC16 Concentration in Blood (Pre-LPS Challenge)

    Time frame: Day 10

    CC16 concentration in blood pre-LPS challenge (Day 10)

  33. CC16 Concentration in Blood (Post-LPS Challenge)

    Time frame: Day 11

    CC16 concentration in blood post-LPS challenge (Day 11)

  34. Basophils in Blood (Pre-LPS Challenge)

    Time frame: day 10

    Basophils in blood pre-LPS challenge (Day 10)

  35. Basophils in Blood (Post-LPS Challenge)

    Time frame: Day 11

    Basophils in blood post-LPS challenge (Day 11)

  36. Eosinophils in Blood (Pre-LPS Challenge)

    Time frame: Day 10

    Eosinophils in blood pre-LPS challenge (Day 10)

  37. Eosinophils in Blood (Post-LPS Challenge)

    Time frame: Day 11

    Eosinophils in blood post-LPS challenge (Day 11)

  38. Lymphocytes in Blood (Pre-LPS Challenge)

    Time frame: Day 10

    Lymphocytes in blood pre-LPS challenge (Day 10)

  39. Lymphocytes in Blood (Post-LPS Challenge)

    Time frame: Day 11

    Lymphocytes in blood post-LPS challenge (Day 11)

  40. Monocytes in Blood (Pre-LPS Challenge)

    Time frame: Day 10

    Monocytes in blood pre-LPS challenge (Day 10)

  41. Monocytes in Blood (Post-LPS Challenge)

    Time frame: Day 11

    Monocytes in blood post-LPS challenge (Day 11)

  42. Neutrophils in Blood (Pre-LPS Challenge)

    Time frame: Day 10

    Neutrophils in blood pre-LPS challenge (Day 10)

  43. Neutrophils in Blood (Post-LPS Challenge)

    Time frame: Day 11

    Neutrophils in blood post-LPS challenge (Day 11)

  44. Maximum Plasma Concentration (Cmax) of AZD2423 at Steady State

    Time frame: Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

    Steady state pharmacokinetic (PK) profile measured on Day 10

  45. Time to Cmax (Tmax) of AZD2423 at Steady State

    Time frame: Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

    Steady state PK profile measured on Day 10

  46. Area Under the Plasma Concentration-time Curve From Zero to 24 Hours (AUC(0-24)) of AZD2423 at Steady State

    Time frame: Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

    Steady state PK profile measured on Day 10

  47. Area Under the Plasma Concentration-time Curve From Zero to 8 Hours (AUC(0-8)) of AZD2423 at Steady State

    Time frame: Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

    Steady state PK profile measured on Day 10

  48. Number of Participants With Clinically Relevant Treatment-related Changes in Laboratory Variables Other Than Monocytes

    Time frame: up to 47 days (visit 1 to visit 6)

  49. Number of Participants With Clinically Relevant Changes in Vital Signs

    Time frame: up to 47 days (visit 1 to visit 6)

  50. Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Variables

    Time frame: up to 47 days (visit 1 to visit 6)

  51. Number of Participants With Clinically Relevant Changes in Physical Examination

    Time frame: up to 47 days (visit 1 to visit 6)

  52. Number of Participants With Treatment-related or Clinically Relevant Changes in Spirometry (Forced Expiratory Volume in 1 Second [FEV1], Forced Vital Capacity [FVC] Pre-bronchodilator)

    Time frame: up to 47 days (visit 1 to visit 6)

  53. CC16 Concentration in BAL (Post-LPS Challenge)

    Time frame: Day 11

    Post-LPS challenge CC16 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase IIa Study to Investigate the Effects of 100mg AZD2423 as an Oral Tablet in Subjects With Mild COPD Following Segmental Endobronchial LPS Instillation

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2010
Registry last updated
Apr 10, 2015

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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