Mild to severe persistent asthma.
Conditions
Interventions
Trade Name: Deltacortril Enteric
Product Name: Prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject aged between 18-65 years inclusive at screening. 2. Have a history of mild to severe persistent asthma that must be documented for a minimum of 6 months prior to entry to the study, with exclusion of other significant pulmonary diseases. 3. A female subject of childbearing potential must be using effective contraceptive measures, as defined in POL/GMO/003: 4. Body mass index within the range 19-31 kg.m-2 5. Able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study. 2. The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation. 3. Subject is female who is pregnant or lactating. 4. Currently or planning to take during the study regular medication (including over-the-counter) except for medication allowed in inclusion criteria. 5. 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. 6. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments. 7. History of abnormal bruising or bleeding. 8. Female subjects who are unwilling or unable to use an appropriate method of contraception 9. Concomitant medications that may interfere with study procedures or evaluations. Examples include: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate and compare the expression of key severe asthma targets at baseline such as IL-13, IKK2, p38 and CLCA1 in mild to moderate asthmatic vs. severe asthmatic subjects. • To evaluate and compare changes in the expression (from baseline) of key severe asthma targets in response to a two week course of corticosteroids (prednisolone) in mild to moderate asthmatic vs. severe asthmatic subjects. • To evaluate and compare airway pathology (e.g. inflammatory cells, airway thickness) at baseline, in relation to asthma severity. • To evaluate and compare changes in airway pathology (from baseline) following a two week course of corticosteroids (prednisolone) in mild to moderate asthmatics vs. severe asthmatics. ;Secondary Objective: • To evaluate and compare the expression of key biomarkers (at baseline and change from baseline following a two week course of corticosteroids) in mild to moderate asthmatic vs. severe asthmatic subjects. • To identify airway and systemic biomarkers associated with target expression and clinical measurements at baseline; as well as changes in biomarker expression that are associated with changes in target expression and changes in clinical measurements following the two week course of corticosteroids.;Primary end point(s): This study will assess multiple parameters in asthmatic patients at baseline and following a 2 week course of high dose corticosteroid (prednisolone therapy). These fall in to four main categories: 1. Those characterising airway pathology - histopathology; sputum ;BAL/bronchial wash; bronchial brushings 2. Those delineating target expression - protein expression; mRNA expression; specific pharmacology or target expression in blood; inflammatory markers in blood; proteomic analysis 3. Biomarkers - of disease severity; associated with target expression; of corticosteroid response 4. Clinical measurements - associated with disease severity; of corticosteroid response | — |
Countries
United Kingdom
Outcome results
None listed