NCT00860821

Brief Summary

The purpose of this methodology study is to evaluate the effect of AZD8309 on cells and inflammatory biomarkers in nasal lavage and blood after nasal challenge with lipopolysaccharide (LPS)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 28, 2009

Status Verified

October 1, 2009

First QC Date

March 11, 2009

Last Update Submit

October 27, 2009

Conditions

Healthy

Keywords

Healthy subjectsLPSEffectIntranasally

Outcome Measures

Primary Outcomes (1)

  • Neutrophil numbers in nasal lavage

    3 times each in the end of two treatment periods

Secondary Outcomes (2)

  • Cells and inflammatory biomarkers in nasal lavage

    3 times in the end of the two treatment periods

  • Cells and inflammatory biomarkers in blood

    2 times in the beginning and 5 times in the end of the two treatment periods

Study Arms (2)

1

EXPERIMENTAL

AZD8309

Drug: AZD8309

2

PLACEBO COMPARATOR

Placebo

Drug: AZD8309

Interventions

AZD8309DRUG

oral solution 30 mg/g, dose: 300mg bid for 3 days

1

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men or healthy, permanently sterilized, women aged 18 to 50 years inclusive, non-smokers or ex-smokers, Body Mass Index 18 to 30 kg/m2 and minimum body weight of 50 kg
  • Blood neutrophil count above 2.2x10\^9/L

You may not qualify if:

  • Clinical relevant disease and/or abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Malmo, Sweden

Location

Related Publications (1)

  • Leaker BR, Barnes PJ, O'Connor B. Inhibition of LPS-induced airway neutrophilic inflammation in healthy volunteers with an oral CXCR2 antagonist. Respir Res. 2013 Dec 16;14(1):137. doi: 10.1186/1465-9921-14-137.

    PMID: 24341382DERIVED

MeSH Terms

Interventions

AZD8309

Study Officials

  • Lars Olaf Cardell

    Department of Otorhinolaryngology, Malmö University Hospital, Sweden

    PRINCIPAL INVESTIGATOR

  • Leif Eriksson

    AstraZeneca R&D Lund, Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

March 1, 2009

Study Completion

October 1, 2009

Last Updated

October 28, 2009

Record last verified: 2009-10

Locations

SE(1)