Phase 2
N=44
Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease · Lung Disease
Bottom Line
View on ClinicalTrials.gov: NCT01153321 ↗Enrolled (actual)
44
Serious AEs
6.8%
Results posted
Oct 2014
Primary outcome: Primary: Absolute Monocyte Count in BAL Post-LPS Challenge — 398; 514.4 x10^4 cells/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD2423 (Drug); AZD2423 Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Monocyte Count in BAL Post-LPS Challenge |
398; 514.4 | — |
| SECONDARY Total Neutrophils in Biopsy Sample (Post-LPS Challenge) |
20.7; 34.04 | — |
| SECONDARY Total Macrophages in Biopsy Sample (Post-LPS Challenge) |
28.44; 41.17 | — |
| SECONDARY CD45+ in Biopsy Sample (Post-LPS Challenge) |
200.7; 203.2 | — |
| SECONDARY CD3+ in Biopsy Sample (Post-LPS Challenge) |
71.84; 81.1 | — |
| SECONDARY Biopsy PAS Reaction Grade (Post-LPS Challenge) |
2.55; 2.5 | — |
| SECONDARY Biopsy Epithelium Grade (Post-LPS Challenge) |
2.32; 2.29 | — |
| SECONDARY Eosinophils in BAL (Post-LPS Challenge) |
28.15; 61.35 | — |
| SECONDARY Lymphocytes in BAL (Post-LPS Challenge) |
129.7; 161.7 | — |
| SECONDARY Neutrophils in BAL (Post-LPS Challenge) |
2063; 1890 | — |
| SECONDARY Macrophages in BAL (Post-LPS Challenge) |
771.1; 917.7 | — |
| SECONDARY TNF α Concentration in BAL (Post-LPS Challenge) |
2.16; 3.11 | — |
| SECONDARY CCL2 Concentration in BAL (Post-LPS Challenge) |
82.47; 46.25 | — |
| SECONDARY IL-1β Concentration in BAL (Post-LPS Challenge) |
0.91; 1.05 | — |
| SECONDARY IL-6 Concentration in BAL (Post-LPS Challenge) |
13.97; 19.76 | — |
| SECONDARY IL-8 Concentration in BAL (Post-LPS Challenge) |
182.5; 207.8 | — |
| SECONDARY RANTES Concentration in BAL (Post-LPS Challenge) |
3.89; 4.82 | — |
| SECONDARY SP-D Concentration in BAL (Post-LPS Challenge) |
637.3; 799.1 | — |
| SECONDARY SAA Concentration in Blood (Pre-LPS Challenge) |
2312; 2510 | — |
| SECONDARY SAA Concentration in Blood (Post-LPS Challenge) |
18615; 16312 | — |
| SECONDARY CCL2 Concentration in Blood (Pre-LPS Challenge) |
1212; 323.4 | — |
| SECONDARY CCL2 Concentration in Blood (Post-LPS Challenge) |
1182; 292.9 | — |
| SECONDARY IL-1β Concentration in Blood (Pre-LPS Challenge) |
1.26; 1.14 | — |
| SECONDARY IL-1β Concentration in Blood (Post-LPS Challenge) |
1.12; 1.12 | — |
| SECONDARY IL-6 Concentration in Blood (Pre-LPS Challenge) |
2.61; 2.55 | — |
| SECONDARY IL-6 Concentration in Blood (Post-LPS Challenge) |
4.41; 2.87 | — |
| SECONDARY IL-8 Concentration in Blood (Pre-LPS Challenge) |
8.37; 9.47 | — |
| SECONDARY IL-8 Concentration in Blood (Post-LPS Challenge) |
12.14; 8.85 | — |
| SECONDARY TNF-α Concentration in Blood (Pre-LPS Challenge) |
13.07; 12.55 | — |
| SECONDARY TNF-α Concentration in Blood (Post-LPS Challenge) |
12.11; 11.19 | — |
| SECONDARY SP-D Concentration in Blood (Pre-LPS Challenge) |
201.8; 181.6 | — |
| SECONDARY SP-D Concentration in Blood (Post-LPS Challenge) |
198.8; 185.6 | — |
| SECONDARY CC16 Concentration in Blood (Pre-LPS Challenge) |
123.2; 125.4 | — |
| SECONDARY CC16 Concentration in Blood (Post-LPS Challenge) |
113.7; 121.6 | — |
| SECONDARY Basophils in Blood (Pre-LPS Challenge) |
2.87; 3.06 | — |
| SECONDARY Basophils in Blood (Post-LPS Challenge) |
2.68; 3.02 | — |
| SECONDARY Eosinophils in Blood (Pre-LPS Challenge) |
17.19; 17.32 | — |
| SECONDARY Eosinophils in Blood (Post-LPS Challenge) |
15.7; 19.8 | — |
| SECONDARY Lymphocytes in Blood (Pre-LPS Challenge) |
226.6; 215.2 | — |
| SECONDARY Lymphocytes in Blood (Post-LPS Challenge) |
215.7; 198.8 | — |
| SECONDARY Monocytes in Blood (Pre-LPS Challenge) |
45.17; 51.11 | — |
| SECONDARY Monocytes in Blood (Post-LPS Challenge) |
51.99; 63.33 | — |
| SECONDARY Neutrophils in Blood (Pre-LPS Challenge) |
461.6; 464.4 | — |
| SECONDARY Neutrophils in Blood (Post-LPS Challenge) |
552.4; 514.7 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of AZD2423 at Steady State |
228.77 | — |
| SECONDARY Time to Cmax (Tmax) of AZD2423 at Steady State |
0.3 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Zero to 24 Hours (AUC(0-24)) of AZD2423 at Steady State |
1454.14 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Zero to 8 Hours (AUC(0-8)) of AZD2423 at Steady State |
801.25 | — |
| SECONDARY Number of Participants With Clinically Relevant Treatment-related Changes in Laboratory Variables Other Than Monocytes |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant Changes in Vital Signs |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Variables |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant Changes in Physical Examination |
0; 0 | — |
| SECONDARY 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) |
0; 0 | — |
| SECONDARY CC16 Concentration in BAL (Post-LPS Challenge) |
2256; 2589 | — |
Summary
The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01153321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.