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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 the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.

Investigation of the effect of oral treatment with 100 mg AZD2423 in subjects with mild Chronic Obstructive Pulmonary Disease (COPD)

D3320C00001 Clinical Study Report Synopsis

Research Site

A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase IIa Study to Investigate the Effects of 100mg AZD2423 as an oral tablet in Subjects with Mild COPD Following Segmental Endobronchial LPS Instillation

Age Continuous

Gender, Male/Female

Monocyte count in BAL post-LPS challenge (Day 11)

Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge

Absolute monocyte count in BAL post-LPS challenge

Pre-challenge = Day 11. Biopsies taken from left lingula. Cells counted in subepithelium.

Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.

Total neutrophils in biopsy sample (post-LPS challenge)

Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.

Total macrophages in biopsy sample (post-LPS challenge)

CD45+ in biopsy sample (post-LPS challenge)

CD3+ in biopsy sample (post-LPS challenge)

Biopsies stained using PAS method. Graded on
subjective scale (1=normal; 2=PAS positive cell
hypertrophy; 3=PAS positive cell hyperplasia;
4=Metaplasia with PAS positive cells throughout
mucosa; 5=Metaplasia and/or squamous plates with
loss of PAS positive cells).

Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Thirteen patients had missing observations.

Biopsy PAS reaction grade (post-LPS challenge)

Biopsies (from right middle lobe) were assessed for routine histopathology. Epithelial morphology was graded on subjective scale from 1 to 5. 1=normal; 2=PAS positive cell
hypertrophy; 3=PAS positive cell hyperplasia;
4=Metaplasia with PAS positive cells throughout
mucosa; 5=Metaplasia and/or squamous plates with
loss of PAS positive cells

Biopsy Epithelium grade (post-LPS challenge)

Post-LPS challenge eosinophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.

Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Five patients had missing observations.

Eosinophils in BAL (post-LPS challenge)

Post-LPS challenge lymphocyte differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.

Lymphocytes in BAL (post-LPS challenge)

Post-LPS challenge neutrophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.

Neutrophils in BAL (post-LPS challenge)

Post-LPS challenge macrophage differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.

Macrophages in BAL (post-LPS challenge)

Post-LPS challenge TNF α concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.

TNF α concentration in BAL (post-LPS challenge)

Post-LPS challenge CCL2 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

CCL2 concentration in BAL (post-LPS challenge)

Post-LPS challenge IL-1β concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

IL-1β concentration in BAL (post-LPS challenge)

Post-LPS challenge IL-6 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

IL-6 concentration in BAL (post-LPS challenge)

Post-LPS challenge IL 8 concentration in BAL. LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

IL-8 concentration in BAL (post-LPS challenge)

Post-LPS challenge RANTES concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

RANTES concentration in BAL (post-LPS challenge)

Post-LPS challenge SP-D concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

SP-D concentration in BAL (post-LPS challenge)

SAA concentration in blood pre-LPS challenge (Day 10).

SAA concentration in blood (pre-LPS challenge)

SAA concentration in blood post-LPS challenge (Day 11)

SAA concentration in blood (post-LPS challenge)

CCL2 concentration in blood pre-LPS challenge (Day 10)

CCL2 concentration in blood (pre-LPS challenge)

CCL2 concentration in blood post-LPS challenge (Day 11).

CCL2 concentration in blood (post-LPS challenge)

IL-1β concentration in blood pre-LPS challenge (Day 10)

IL-1β concentration in blood (pre-LPS challenge)

IL-1β concentration in blood post-LPS challenge (Day 11)

IL-1β concentration in blood (post-LPS challenge)

IL-6 concentration in blood pre-LPS challenge (Day 10)

IL-6 concentration in blood (pre-LPS challenge)

IL-6 concentration in blood post-LPS challenge (Day 11)

IL-6 concentration in blood (post-LPS challenge)

IL-8 concentration in blood pre-LPS challenge (Day 10)

IL-8 concentration in blood (pre-LPS challenge)

IL-8 concentration in blood post-LPS challenge (Day 11)

IL-8 concentration in blood (post-LPS challenge)

TNF-α concentration in blood pre-LPS challenge (Day 10)

TNF-α concentration in blood (pre-LPS challenge)

TNF-α concentration in blood post-LPS challenge (Day 11)

TNF-α concentration in blood (post-LPS challenge)

SP-D concentration in blood pre-LPS challenge (Day 10)

SP-D concentration in blood (pre-LPS challenge)

SP-D concentration in blood post-LPS challenge (Day 11)

SP-D concentration in blood (post-LPS challenge)

CC16 concentration in blood pre-LPS challenge (Day 10)

Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Three patients had missing observations.

CC16 concentration in blood (pre-LPS challenge)

CC16 concentration in blood post-LPS challenge (Day 11)

CC16 concentration in blood (post-LPS challenge)

Basophils in blood pre-LPS challenge (Day 10)

Basophils in blood (pre-LPS challenge)

Basophils in blood post-LPS challenge (Day 11)

Basophils in blood (post-LPS challenge)

Eosinophils in blood pre-LPS challenge (Day 10)

Eosinophils in blood (pre-LPS challenge)

Eosinophils in blood post-LPS challenge (Day 11)

Eosinophils in blood (post-LPS challenge)

Lymphocytes in blood pre-LPS challenge (Day 10)

Lymphocytes in blood (pre-LPS challenge)

Lymphocytes in blood post-LPS challenge (Day 11)

Lymphocytes in blood (post-LPS challenge)

Monocytes in blood pre-LPS challenge (Day 10)

Monocytes in blood (pre-LPS challenge)

Monocytes in blood post-LPS challenge (Day 11)

Monocytes in blood (post-LPS challenge)

Neutrophils in blood pre-LPS challenge (Day 10)

Neutrophils in blood (pre-LPS challenge)

Neutrophils in blood post-LPS challenge (Day 11)

Neutrophils in blood (post-LPS challenge)

Steady state pharmacokinetic (PK) profile measured on Day 10

All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE. 

Maximum plasma concentration (Cmax) of AZD2423 at steady state

Steady state PK profile measured on Day 10

Time to Cmax (tmax) of AZD2423 at steady state

Area under the plasma concentration-time curve from zero to 24 hours (AUC(0-24)) of AZD2423 at steady state

Area under the plasma concentration-time curve from zero to 8 hours (AUC(0-8)) of AZD2423 at steady state

Number of participants with clinically relevant treatment-related changes in laboratory variables other than monocytes

Number of participants with clinically relevant changes in vital signs

Number of participants with clinically relevant changes in electrocardiogram (ECG) variables

Number of participants with clinically relevant changes in physical examination

Number of participants with treatment-related or clinically relevant changes in spirometry (Forced expiratory volume in 1 second [FEV1], Forced vital capacity [FVC] pre-bronchodilator)

Post-LPS challenge CC16 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.

Arms	Assigned Interventions
Experimental: 1 Oral treatment	Drug: AZD2423 100mg Oral dose od
Placebo Comparator: 2 Oral treatment	Drug: AZD2423 Placebo Oral dose od

Investigation of the effect of oral treatment with 100 mg AZD2423 in subjects with mild Chronic Obstructive Pulmonary Disease (COPD)

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

D3320C00001 Clinical Study Report Synopsis

D3320C00001 CSR Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator