Asthma
Conditions
Keywords
bronchoscopy, Sputum induction, Prednisolone, Asthma, biomarkers
Brief 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.
Interventions
DRUGPrednisolone
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.
PROCEDUREBronchoscopy
All subjects will undergo bronchoscopy assessments which will involve insertion of a standard bronchoscope.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airway pathology endpoints Target Validation endpoints Biomarker endpoints Clinical endpoints | Through 2 weeks of Prednisolone dosing | biomarkers, vital signs, ECG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Through 2 weeks of prednisolone dosing. | biomarkers |
Countries
United Kingdom
Outcome results
None listed