| June 19, 2008 |
| November 3, 2008 |
| June 2008 |
| September 2008 (final data collection date for primary outcome measure) |
- Safety and Tolerability of AZD9668 through the recording and evaluation of adverse events, vital signs, ECG, lung function, haematology, clinical chemistry and urinalysis [ Time Frame: throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ] [ Designated as safety issue: Yes ]
- Pharmacokinetic effects of AZD9668 measured in plasma and urine [ Time Frame: Variables measured from pre-dose on day -1 to day 15 (end of dosing) ] [ Designated as safety issue: No ]
|
| Same as current |
| Complete list of historical versions of study NCT00703391 on ClinicalTrials.gov Archive Site |
- Sputum absolute and differential neutrophil count [ Time Frame: Variables will be measured from pre-dose day -1 to post-dose on day 14 ] [ Designated as safety issue: Yes ]
- AZD9668 sputum concentrations [ Time Frame: Variables will be measured from pre-dose day -1 to post-dose on day 14 ] [ Designated as safety issue: No ]
- Quantitative sputum bacteriology [ Time Frame: Variables will be measured from pre-dose day 1 to post-dose on day 15 ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients |
| A 2-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Tolerability and Pharmacokinetics of Orally Administered AZD9668 in Patients With COPD |
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 |
| |
| Phase II |
| Interventional |
| Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
| Chronic Obstructive Pulmonary Disease (COPD) |
- Drug: AZD9668
- Drug: Placebo
|
- Experimental: Active Treatment
- Placebo Comparator: Placebo Treatment
|
| |
| |
| Completed |
| 18 |
| October 2008 |
| September 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 40 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Germany |
| |
| NCT00703391 |
| Dr.Noel Snell MB FRCP, Medical Science Director, RITA Emerging Project Team, AstraZeneca Pharmaceuticals |
| D0520C00002 |
| AstraZeneca |
|
| Principal Investigator: |
Kristina Panke |
Parexel International GmbhH (CRO) |
|
|
| AstraZeneca |
| November 2008 |
