Distribution of Neutrophils in Bronchial Mucosal Tissue in Asthma Patients Before and After 4 Weeks Treatment With AZD 5069

AstraZeneca13 enrolled

Overview

Distribution of neutrophils in bronchial mucosal tissue in asthma patients before and after 4 wk treatment with AZD 5069

The purpose is to investigate the bronchial tissue neutrophil counts and distribution in asthma patients after 4 week oral treatment with AZD 5069

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

AZD5069DRUG

oral BD administration of 45 mg AZD5069

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female patients of Caucasian origin, aged between 18 to 65 years, inclusive, at the time informed consent is obtained. 2. Physician based (according to GINA 2011) diagnosis of asthma for at least 6 months prior to the date informed consent is obtained and confirmed by 1 of the detailed respiratory criteria stated in the CSP 3. Morning prebronchodilator (ie, after abstinence from short-acting and long-acting ß-agonist treatment for ≥ 6 and ≥ 12 hours, respectively) FEV1 of ≥70% of predicted normal (PN) for age, sex and height at enrolment 4. Increased number of neutrophils in induced sputum samples at baseline, with a relative neutrophil count of ≥ 50% of total sputum cell count 5. Physician prescribed daily use of medium or high dose ICS (≥ fluticasone 250 μg to ≤ 1.000 µg or the equivalent daily, as defined in GINA 2011; see CSP Appendix E) plus LABA. Exclusion Criteria: 1. History of clinically relevant allergies or idiosyncrasies to AZD5069 or other investigational CXCR2 antagonists, or any inactive ingredient(s) of the IMP, or tool-substances (eg, salbutamol, local anaesthetics) used for the purpose of this study 2. History of severe asthma exacerbation requiring hospitalization within the last 12 months before screening. 3. Asthma exacerbation requiring a treatment course of systemic (ie, oral or parenteral) corticosteroids within the 3 months before screening or ≥ 3 courses within the last 12 months before screening. 4. Moderate to severe airflow limitation (FEV1 \<70% PN) 5. Any chronic lower respiratory disease other than asthma (see CSP for details) that, as judged by the Investigator or Medical Monitor, would interfere with the evaluation of the IMP or interpretation of patient safety or study results. \-

Locations (1)

Research Site

Großhansdorf, Germany

Outcomes

Primary Outcomes

Summary for Change From Baseline of Mean Global Semi-quantitative Score Values for Neutrophils in Bronchial Biopsies

Change from baseline reflects the Week 4 value minus the baseline value. Baseline value is Day-14 measurement. For semi-quantitative scores, 1= few number of Neutrophils, 2= moderate number of Neutrophils, 3= abundant of Neutrophils. For this end point the reduction in mean of semi-quantitative (arbitrary) scores indicates better result, i.e. lower numbers of Neutrophils. The scores given for the biopsies taken at screening and end of treatment is the mean global semi-quantitative scores for the three compartments intraepithelial, subepithelial and submucosal.

Time frame: Baseline and Week 4

Summary for Change From Baseline Neutrophils in Sputum

Change from Baseline reflects the Day 8, Day22 and Day29 minus the baseline value.

Time frame: Baseline, Day 8, Day 22 and Day29

Summary for Change From Baseline Neutrophil Cell Counts in Blood

Change from Baseline reflects the Day 2, Day 8, Day 15, Day 22, Day29 and Day 34 minus the baseline value

Time frame: Baseline, Day 2, Day 8, Day 15, Day 22, Day29 and Day 34

Secondary Outcomes

Summary for Change From Baseline for IL-8 by Type of Sample

Change from baseline reflects the Day 29 value minus the baseline value.

Time frame: Baseline and Day 29

Summary for Change From Baseline for GRO-alpha by Type of Sample

Change from baseline reflects the Day 29 value minus the baseline value.

Time frame: Baseline and Day 29

Summary for Change From Baseline for MMP-9 by Type of Sample

Change from baseline reflects the Day 29 value minus the baseline value.

Data from ClinicalTrials.gov

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