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

NCT01890148 | Completed Phase 1 Results

• 1 other identifier: D3551C00003
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  Baseline, Day 2, Day 8, Day 15, Day 22, Day29 and Day 34

Secondary Outcomes (10)

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

  Baseline and Day 29

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

  Baseline and Day 29

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

  Baseline and Day 29

• Summary Statistics for AUC0-4hrs on Day 29/ Visit T7 (PK Analysis Set)

  At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)

• Summary Statistics for Cmin on Day 29/ Visit T7 (PK Analysis Set)

  At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)

Study Arms (1)

1

EXPERIMENTAL

oral BD administration of 45 mg AZD5069

Drug: AZD5069

Interventions

AZD5069 DRUG

oral BD administration of 45 mg AZD5069

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients of Caucasian origin, aged between 18 to 65 years, inclusive, at the time informed consent is obtained.
• 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
• 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
• Increased number of neutrophils in induced sputum samples at baseline, with a relative neutrophil count of ≥ 50% of total sputum cell count
• 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.

You may not qualify if:

• 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
• History of severe asthma exacerbation requiring hospitalization within the last 12 months before screening.
• 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.
• Moderate to severe airflow limitation (FEV1 \<70% PN)
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Großhansdorf, Germany

Location

MeSH Terms

Conditions

Asthma

Interventions

N-(2-(2,3-difluoro-6-benzylthio)-6-(3,4-dihydroxybutan-2-yloxy)pyrimidin-4-yl)azetidine-1-sulfonamide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Larsson, Bengt
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

+46 (0) 317064277

Study Officials

• Kai Richter, MSD

  Astrazeneca Sweden

  STUDY DIRECTOR

• Klaus F Rabe, MD

  Lung Clinic Grosshansdorf Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: July 1, 2013
• Study Start: March 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 25, 2016
• Results First Posted: February 25, 2016

Record last verified: 2016-01

Locations

DE (1)