Comparison Of Molecular Targets In Mild To Severe Asthmatics And Healthy Subjects

Phase 1

Terminated

• Conditions: Asthma
• Interventions: Procedure: Bronchoscopsy; Procedure: Prednisolone

• Registration Number: NCT00331058
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The primary goal of this study is to compare the expression of key GSK drug targets across the 4 asthma phenotypes and healthy subjects and secondarily to evaluate changes in target expression in response to a 2-week course of corticosteroids across the 4 asthma phenotypes. Each asthmatic subject in this study will undergo two bronchoscopies. Each healthy subject will undergo one bronchoscopy.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-18
• Study First Submitted: 2006-05-26
• Study First Submitted QC: 2006-05-26
• Study First Posted: 2006-05-29
• Primary Completion: 2011-07-07
• Study Completion: 2011-07-07
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
asthmatic volunteers	Bronchoscopsy	receive prednisolone for 14-16 days
healthy volunteers	Prednisolone	control group not receiving prednisolone

Primary Outcome Measures

Name	Time	Method
evaluate changes in target expression in response to a 2 week course of corticosteroids across the 4 asthma phenotypes	visits 3 through to and including visit 6
compare key drug targets across 4 asthma phenotypes and healthy subjects	visits 3 through to and including visit 6

Secondary Outcome Measures

Name	Time	Method
Cytospins	visits 3 through to and including visit 6
Histopathology on bronchial biopsies	visits 3 through to and including visit 6
target expression in the blood	visits 3 through to and including visit 6
inflammatory markers	visits 3 through to and including visit 6
Quality of life (QoL) and symptom scores	visits 3 through to and including visit 6
activation state of a signalling pathway	visits 3 through to and including visit 6
target protein expression	visits 3 through to and including visit 6
Measures of pulmonary inflammation	visits 3 through to and including visit 6
Assessments of lung structure	visits 3 through to and including visit 6
new targets and biomarkers	visits 3 through to and including visit 6
Changes in medication	visits 3 through to and including visit 6
lung function	visits 3 through to and including visit 6
Radiological Parameters	visits 3 through to and including visit 6
Pharmacogenomics from blood samples	visits 3 through to and including visit 6
Whole Blood TaqMan and/or transcriptomic analysis	visits 3 through to and including visit 6
TaqMan and/or Differential Gene Expression and Proteomics	visits 3 through to and including visit 6

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Philadelphia, Pennsylvania, United States