Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomised, Multi-centre, 3-way Cross-over, Single-dose Phase II Study to Investigate the Local and Systemic Effects of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.
Status | Completed |
Enrollment | 28 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of COPD - Current or ex-smokers - FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC < 70% Exclusion Criteria: - Any clinically significant disease or disorder - Any clinically relevant abnormal findings at screening examinations - Family history or presence of glaucoma - Need of long term oxygen therapy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Poland | Research Site | Bialystok | |
Poland | Research Site | Bydgoszcz | |
Poland | Research Site | Lódz | |
Poland | Research Site | Proszowice |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose | Maximum FEV1 value | 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h | No |
Primary | Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose | Trough FEV1 value | 22 h, 24 h, 26 h | No |
Secondary | Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose | Average FEV1 value | 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h | No |
Secondary | Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose | Maximum FVC value | 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h | No |
Secondary | Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose | Average systolic blood pressure value | 0, 30 min, 2 h, 4 h | No |
Secondary | Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose | Average diastolic blood pressure value | 0, 30 min, 2 h, 4 h | No |
Secondary | Pulse, Average Effect Over 0 - 4 Hours Post-dose | Average pulse value | 0, 30 min, 2 h, 4 h | No |
Secondary | Heart Rate, Average Effect Over 0 - 4 Hours Post-dose | Average heart rate value | 0, 30 min, 2 h, 4 h | No |
Secondary | QTcF, Average Effect Over 0 - 4 Hours Post-dose | Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula | 0, 30 min, 2 h, 4 h | No |
Secondary | Plasma AZD8683 Cmax | Maximum plasma concentration of AZD8683 | 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h | No |
Secondary | Plasma AZD8683 AUC0-24 | Area under the AZD8683 plasma concentration curve from 0 to 24 hours | 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h | No |
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 |
NCT02926534 -
Cross-Sectional Study of COPD Prevalence Among Smokers, Ex-smokers and Never-Smokers in Almaty, Kazakhstan
|
N/A | |
Completed |
NCT02797392 -
Feasibility of a Preventive Program Against Lifestyle Related Diseases
|
N/A | |
Recruiting |
NCT02415478 -
Bronchioscopic Lung Volume Reduction (BLVR)
|
N/A | |
Completed |
NCT02512510 -
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
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 |
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 |
NCT01615484 -
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
|
N/A | |
Completed |
NCT01908140 -
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Withdrawn |
NCT01908933 -
Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema
|
Phase 3 | |
Completed |
NCT01893476 -
A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management
|
N/A | |
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 |