Assessment Of Disease Pathology And Key Therapeutic Targets In Severe Asthma

Asthma Clinical Trial

Official title:

A Study to Assess Disease Pathology and Key Therapeutic Targets in Severe Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00327197
• Other study ID #: RES100769
• Status: Terminated
• Phase: Phase 1
• First received: May 17, 2006
• Last updated: August 2, 2017
• Start date: August 2, 2005
• Est. completion date: June 6, 2011

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate and compare the expression and change in expression of key severe asthma targets at baseline in mile to moderate asthmatics vs. severe asthmatic subjects.

To evaluate and compare the airway pathology at baseline and changes in airway pathology in relation to asthma severity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: June 6, 2011
• Est. primary completion date: June 6, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• History of asthma with exclusion of other significant pulmonary disease.

• Body Mass Index between 19-31 kg.m-2.

• Subjects will be assigned to group 1(mild to moderate) or Group 2 (severe asthmatics) depending on their Lung Function test results.

Exclusion criteria:

• As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study.

• History of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.

• Subject is female who is pregnant or lactating.

• Currently or planning to take during the study regular medication (including over-the-counter) except for medication allowed in inclusion criteria.

• Having participated within 30 days or 5 half-lives, whichever is longer of the first dose in a study using new molecular entity, or the first dose in any other study investigating drugs or having participated within one month of the first dose in a study with invasive procedures.

• History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments.

• History of abnormal bruising or bleeding.

• History of alcohol or drug abuse.

• Doing night-shift work within at least 5 days prior to dosing until completion of the study.

• Anticoagulants except low dose of Aspirin (80 mg per day) (for bronchoscopy).

• Beta blockers except for low dose Atenolol (25 mg/day) or Metoprolol (50 mg/day) (for bronchoscopy).

• Use of Cytochrome P450 inhibitors.

• History of hypersensitivity to any of the following medications: Lidocaine, Fentanyl, Versed, Demerol, Midazolam, Epinephrine, Flumazenil and Naloxone.

• History of hypersensitivity to bronchodilator (such as Albuterol).

In addition, the following additional exclusion criteria must apply to mild to moderate persistent asthmatics on regular inhaled steroids:

• Changed asthma medication within the 4 weeks prior to screening.

• Has had an asthma exacerbation in the previous month.

• Known sensitivity or allergy to prednisolone.

• Current use or use within the previous 3 months of oral corticosteroids.

• Current use of Methotrexate, cyclosporine and PDE inhibitors

• History of tuberculosis, diabetes mellitus, osteoporosis, severe hypertension, glaucoma , severe affective disorder and peptic ulceration.

In addition, the following additional exclusion criteria must apply to severe persistent asthmatics with clinical controlled asthma symptoms:

• Changed asthma medication within the 4 weeks prior to screening.

• Has had an asthma exacerbation in the previous month.

• sensitivity or allergy to prednisolone.

• History of tuberculosis, diabetes mellitus, osteoporosis, hypertension, glaucoma, severe affective disorder and peptic ulceration.

• Current use or use within the previous 4 weeks of oral prednisolone or equivalent of greater than 20mg daily.

• Current use of Methotrexate, cyclosporin.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Prednisolone
Subjects will be administered oral prednisolone at a dose of 0.5 mg/kg, up to a maximum of 40 mg per day for 14 days.

Procedure:
• Bronchoscopy
All subjects will undergo bronchoscopy assessments which will involve insertion of a standard bronchoscope.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Leicester	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway pathology endpoints Target Validation endpoints Biomarker endpoints Clinical endpoints	biomarkers, vital signs, ECG	Through 2 weeks of Prednisolone dosing
Secondary	Expression of airway and systemic biomarkers. Relationship between changes in target expression and clinical measures of disease activity. Relationship between steady state plasma exposure of prednisolone and pharmacodynamic biomarkers.	biomarkers	Through 2 weeks of prednisolone dosing.

External Links

•   Results for study RES100769 can be found on the GSK Clinical Study Register.