Phase 2
Completed N=63
AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)
Source: ClinicalTrials.gov NCT01215279 ↗Enrolled (actual)
63
Serious AEs
3.2%
Results posted
Oct 2014
Primary outcomePrimary: Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes — 0; 0 Participants
Summary
The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in ECG Variables |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Physical Examination |
0; 0 | — |
| PRIMARY Monocytes at Baseline |
0.47; 0.43 | — |
| PRIMARY Monocytes at End of Treatment |
0.43; 0.55 | — |
| PRIMARY Monocytes at Follow-up |
0.50; 0.52 | — |
| SECONDARY Morning FEV1 at Baseline |
1.3; 1.3 | — |
| SECONDARY Morning FEV1 During Last 7 Days of Treatment |
1.3; 1.4 | — |
| SECONDARY Evening FEV1 at Baseline |
1.3; 1.4 | — |
| SECONDARY Evening FEV1 During Last 7 Days of Treatment |
1.2; 1.4 | — |
| SECONDARY Morning Peak Expiratory Flow (PEF) at Baseline |
190.5; 185.5 | — |
| SECONDARY Morning PEF During Last 7 Days of Treatment |
190.2; 196.4 | — |
| SECONDARY Evening PEF at Baseline |
192.3; 196.2 | — |
| SECONDARY Evening PEF During Last 7 Days of Treatment |
191.9; 204.7 | — |
| SECONDARY Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score at Baseline |
44.4; 45.7 | — |
| SECONDARY EXACT Total Score During Last 7 Days of Treatment |
43.8; 44.6 | — |
| SECONDARY Breathlessness, Cough and Sputum Scale (BCSS) (Evening) Total Score at Baseline |
5.2; 5.3 | — |
| SECONDARY BCSS (Evening) Total Score During Last 7 Days of Treatment |
5.1; 5.1 | — |
| SECONDARY Rescue Medication Use During the Last 7 Days of Treatment |
4.0; 3.5 | — |
| SECONDARY St George's Respiratory Questionnaire for COPD (SGRQ) Total Score at Baseline |
55.9; 57.0 | — |
| SECONDARY SGRQ Total Score at End of Treatment |
52.0; 52.9 | — |
| SECONDARY CCL2 (Chemokine Ligand for CCR2b Receptor) Concentration in Plasma at Baseline |
294; 279 | — |
| SECONDARY CCL2 Concentration in Plasma at End of Treatment |
1286; 272 | — |
| SECONDARY Serum Amyloid-A (SAA) Concentration in Plasma at Baseline |
5175; 4044 | — |
| SECONDARY SAA Concentration in Plasma at End of Treatment |
6325; 4032 | — |
| SECONDARY Areaa Under the Curve From 0 to 24 Hours (AUC 0-24), Population Pharmacokinetic Evaluation of AZD2423 at Steady State |
2780 | — |
| SECONDARY Cmax, Population Pharmacokinetic Evaluation of AZD2423 at Steady State |
198 | — |
| SECONDARY Time to Reach Maximum Concentration (Tmax) Population Pharmacokinetic Evaluation of AZD2423 at Steady State |
1.01 | — |
| SECONDARY Apparent Volume of Distribution at Steady State (Vss/F) Population Pharmacokinetic Evaluation of AZD2423 at Steady State |
1600 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female of non-child bearing potential. Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
- Between 40 and 80 years of age at Visit 1
- Clinical diagnosis of COPD (GOLD stage 2 or 3)
- FEV1/FVC <70% and FEV1 between 30 and 80% of the predicted normal post-bronchodilator (GOLD stage 2 or 3)
- Current or ex-smokers
Exclusion Criteria
- Any clinically significant disease or disorder (including history of abnormal immune function) which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
- Any lung disease other than COPD, recent respiratory infections which have not resolved fully, active tuberculosis or at risk of reactivation of tuberculosis.
- Any 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 to take part or influence the results of the study
- Immunisation with a live vaccine within 3 months or other vaccination within 30 days before planned start of treatment
- Worsening of COPD symptoms within 4 weeks prior to start of study needing hospitalisation, oral steroids or antibiotics.
Data sourced from ClinicalTrials.gov (NCT01215279). 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. Informational only — not medical advice.