Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
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
Status | Completed |
Enrollment | 18 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Germany | Research Site | Berlin |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alanine Aminotransferase (ALT) | ALT level greater than 3 times the upper limit of normal | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) | Yes |
Primary | Aspartate Aminotransferase (AST) | AST level greater than 3 times the upper limit of normal | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) | Yes |
Primary | Creatine Kinase (CK) | Change from baseline to Day 14 | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) | Yes |
Primary | Total Bilirubin | Change from baseline to Day 14 | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) | Yes |
Primary | Creatinine | Creatinine level greater than the upper limit of normal | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) | Yes |
Primary | Haemoglobin (Hb) | Change from baseline to Day 14 | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) | Yes |
Primary | Reticulocytes | Change from baseline to Day 14 | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) | Yes |
Primary | Leucocytes | Change from baseline to Day 14 | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) | Yes |
Primary | QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method) | QTcF interval greater than 450 ms | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) | Yes |
Primary | QTcF | QTcF change from baseline greater than 60 ms | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) | Yes |
Primary | FEV1 (Forced Expiratory Volume in the First Second) | Change from baseline to Day 14 | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) | Yes |
Primary | Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12)) | AUC(0-12) following 14 days' dosing | Pre-dose on day -1 to day 15 (end of dosing) | No |
Primary | Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax) | Cmax following 14 days' dosing | Pre-dose on day -1 to day 15 (end of dosing) | No |
Primary | Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax) | tmax following 14 days' dosing | Pre-dose on day -1 to day 15 (end of dosing) | No |
Primary | Terminal Half-life of Drug in Plasma (t1/2) | t1/2 following 14 days' dosing | Pre-dose on day -1 to day 15 (end of dosing) | No |
Primary | Renal Clearance of Drug From Plasma (CLR) | CLR following 14 days' dosing | Pre-dose on day -1 to day 15 (end of dosing) | No |
Secondary | Sputum Absolute Neutrophil Count | Change from baseline to Day 14 in absolute neutrophil count | Pre-dose day -1 to post-dose on day 14 | Yes |
Secondary | Sputum Differential Neutrophil Count | Change from baseline to Day 14 in percentage neutrophil count | Pre-dose day -1 to post-dose on day 14 | Yes |
Secondary | AZD9668 Sputum Concentrations | Pre-dose day -1 to post-dose on day 14 | No | |
Secondary | Quantitative Sputum Bacteriology | Number of patients with an increase in bacteriological count from Day -1 to Day 15 | Pre-dose day -1 to post-dose on day 15 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03282019 -
Study of Long-term HFNC for COPD Patients With HOT
|
N/A | |
Completed |
NCT05573464 -
A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With the Hydrofluoroolefin Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
|
Phase 3 | |
Recruiting |
NCT06040086 -
Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
|
Phase 3 | |
Not yet recruiting |
NCT06376994 -
Multi-Center Clean Air Randomized Controlled Trial in COPD
|
Phase 3 | |
Completed |
NCT02728674 -
Management of Patients With Respiratory Symptoms in Sweden
|
N/A | |
Completed |
NCT02797392 -
Feasibility of a Preventive Program Against Lifestyle Related Diseases
|
N/A | |
Completed |
NCT02926534 -
Cross-Sectional Study of COPD Prevalence Among Smokers, Ex-smokers and Never-Smokers in Almaty, Kazakhstan
|
N/A | |
Recruiting |
NCT02415478 -
Bronchioscopic Lung Volume Reduction (BLVR)
|
N/A | |
Completed |
NCT02518139 -
A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT02774226 -
Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Completed |
NCT02459080 -
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT03487406 -
Anti-platelet Therapy in the Prevention of Cardiovascular Disease in Patients With COPD (APPLE-COPD: ICON 2)
|
Phase 2 | |
Completed |
NCT02512510 -
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT01893476 -
A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management
|
N/A | |
Completed |
NCT01615484 -
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
|
N/A | |
Withdrawn |
NCT01908933 -
Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema
|
Phase 3 | |
Completed |
NCT01908140 -
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT01701869 -
Microbiology & Immunology of the Chronically-inflamed Airway
|
N/A | |
Recruiting |
NCT02527486 -
Seoul National University Airway Registry
|
N/A | |
Terminated |
NCT01388920 -
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
|
Phase 2 |