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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease

A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

D3550C00002_Revised_Clinical_Study_Protocol.pdf

Research Site

A 4 Week, Double Blind, Placebo Controlled, Randomised, Parallel Group, Multicentre, Phase IIa Study to Investigate the Safety and Tolerability of AZD5069 as Oral Capsules in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease

Adverse event (AE) data, both serious and non-serious. An AE is the development of an undesirable medical condition (eg, nausea, chest pain, tachycardia, laboratory findings) or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.

Physical examination includes assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, musculo-skeletal (including spine and extremities), cardiovascular, lungs and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.

ECGs were recorded in the supine position after the patient has rested for 10 minutes. Heart rate, QRS duration, PR, RR and QT intervals were recorded. Overall evaluation of the ECG is classified as normal, abnormal or borderline. Only participants with ECG at baseline classified as normal are reported (ie, only changes from normal to abnormal).

The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.

The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.

The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.

The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.

The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.

The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.

The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.

High Transaminase Values are defined as a measurment of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than or equal to 3 times the upper limit of normal (ALT ULN = 36 IU/L, AST ULN = 33 IU/L).

The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.

Age Continuous

Gender, Male/Female

Body Mass Index

Study Specific Characteristic

Weight

% Predicted FEV1 at screening

FEV1/FVC at screening

one pack year= 1 pack (20 cigrettes) per day for 1 year, or equivalent 

Nicotine pack years

The spirometric classification of severity COPD now includes four stages: Stage I: Mild; Stage II: Moderate; Stage III: Severe; Stage IV: Very Severe.

GOLD classification

Patients Who Experienced at Least One Adverse Events(s)

Number of Participants With Abnormal Physical Examination Findings

Number of Participants With Abnormal Electrocardiogram (ECG)

Change from Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample)

Change from Baseline to End of Treatment for Body Temperature

Change from Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs)

Change from Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs)

Change from Baseline to End of Treatment for Pulse Rate (Vital Signs)

Change from Baseline to End of Treatment for FEV1 Pre-bronchodilator  (Lung Function Test)

Change from Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test)

Number of Participants Who Developed High Transaminase Values (Clinical Chemistry)

Change from Baseline to End of Treatment for Total Protein (Urinalysis)

At this visit, approximately 1 hour after dosing (at the clinic), a blood sample was collected for determination of drug concentration in plasma.

Plasma concentration of AZD5069 after 1 hour of dosing

The area under the plasma concentration curve is estimated from time 0 (dosing) to 24 hours after dosing.

Area Under the Plasma Concentration Curve of AZD5069

The maximum plasma concentration (Cmax) is the highest level of drug in plasma.

Maximum Plasma Concentration for AZD5069

Time (in relation to dosing) at which the maximum plasma concentration is observed.

Time to Maximum Plasma Concentration for AZD5069

The change in circulating neutrophils in blood is calculated as the visit value minus the Baseline value. Only participants with reduction are considered.

Maximum reduction of Circulating Neutrophils in Blood, from Baseline

Overall Study

22 patients enrolled were not randomized due to eligibility not fulfilled (17 patients) and voluntary discontinuation (5 patients)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo dose	Drug: Placebo Oral dose bid
Experimental: 2 Treatment arm AZD5069 50mg	Drug: AZD5069 50mg Oral dose bid
Experimental: 3 Treatment arm AZD5069 80mg	Drug: AZD5069 80mg Oral dose bid

A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - CIRRUS

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

D3550C00002_Revised_Clinical_Study_Protocol.pdf

D3550C00002_Study_Synopsis.pdf

Trial Results Summaries

Contacts

Contact