Last updated: 11/07/2018 18:11:55
Assessment Of Disease Pathology And Key Therapeutic Targets In Severe Asthma
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: A study to assess disease pathology and key therapeutic targets in severe asthma
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Airway pathology endpoints Target Validation endpoints Biomarker endpoints Clinical endpoints
Timeframe: Through 2 weeks of Prednisolone dosing
Secondary outcomes:
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.
Timeframe: Through 2 weeks of prednisolone dosing.
Interventions:
Drug: Prednisolone
Procedure/surgery: Bronchoscopy
Enrollment:
47
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Desai D, Newby C, Symon FA, Haldar P, Shah S, Gupta S, Bafadhel M, Singapuri A, Siddiqui S, Woods J, Herath A, Myles D, Bradding P, Green R, Kulkarni N, Pavord I, Marshall RP, De Sousa AR, May RD, Wardlaw AJ, Brightling CE. Elevated sputum Interleukin-5 and submucosal eosinophilia in obese individuals with severe asthma. Am J Respir Crit Care Med. 2013;188(6):657-63.
Gupta S, Hartley R, Khan UT, Singapuri A, Hargadon B, Monteiro W, Pavord ID, de Souza AR, Marshall RP, Subramaian D, Parr D, Entwisle J, Siddiqui S, Raj V, Brightling CE. Quantitative computed tomography–derived clusters: Redefining airway remodeling in asthmatic patients. J Allergy Clin Immunol. 2014;133(3):729-738
Medical condition
Asthma
Product
prednisolone
Collaborators
Not applicable
Study date(s)
August 2005 to June 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- History of asthma with exclusion of other significant pulmonary disease.
- Body Mass Index between 19-31 kg.m-2.
- 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.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE3 9QP
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2011-06-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study RES100769 can be found on the GSK Clinical Study Register.
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