Phase 2
Completed N=18
A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Source: ClinicalTrials.gov NCT00703391 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcomePrimary: Alanine Aminotransferase (ALT) — 0; 0 Participants
Summary
The purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alanine Aminotransferase (ALT) |
0; 0 | — |
| PRIMARY Aspartate Aminotransferase (AST) |
0; 0 | — |
| PRIMARY Creatine Kinase (CK) |
2.57; -69.57 | — |
| PRIMARY Total Bilirubin |
0.11; -0.28 | — |
| PRIMARY Creatinine |
1; 1 | — |
| PRIMARY Haemoglobin (Hb) |
-2.0; -0.2 | — |
| PRIMARY Reticulocytes |
-0.15; 1.73 | — |
| PRIMARY Leucocytes |
-0.001; 0.265 | — |
| PRIMARY QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method) |
0; 0 | — |
| PRIMARY QTcF |
0; 0 | — |
| PRIMARY FEV1 (Forced Expiratory Volume in the First Second) |
0.039; -0.110 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12)) |
7560 | — |
| PRIMARY Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax) |
1420 | — |
| PRIMARY Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax) |
1.01 | — |
| PRIMARY Terminal Half-life of Drug in Plasma (t1/2) |
5.89 | — |
| PRIMARY Renal Clearance of Drug From Plasma (CLR) |
6.13 | — |
| SECONDARY Sputum Absolute Neutrophil Count |
-0.4890; -2.5645 | — |
| SECONDARY Sputum Differential Neutrophil Count |
1.8; -4.25 | — |
| SECONDARY AZD9668 Sputum Concentrations |
41.7 | — |
| SECONDARY Quantitative Sputum Bacteriology |
3; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Mild to moderate COPD
- Smokers or ex-smokers
- post-menopausal females
Exclusion Criteria
- Past history or current evidence of clinically significant heart disease
- Lung disease other than COPD
- Treatment with systemic steroids within 8 weeks of study visit 2
- Treatment with antibiotics within 4 weeks of study visit 1 or study visit 2
Data sourced from ClinicalTrials.gov (NCT00703391). 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.