Mepolizumab and exacerbation frequency in refractory eosinophilic asthma. A randomised, double blind, placebo controlled, parallel group trial.
- Conditions
- Refractory Eosinophilic Asthma.
- Registration Number
- EUCTR2005-001932-61-GB
- Lead Sponsor
- niversity Hospitals of Leicester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
1. Refractory asthma as defined by the American Thoracic Society guidelines.
2. Symptoms and objective evidence of variable airflow obstruction as indicated by one or more of the following:
i) >15% increase in FEV1 following 200 micrograms inhaled salbutamol.
ii) >20% within day variability in PEF noted on any day following assessment twice daily over 2 weeks.
iii) and/or a concentration of metacholine causing 20% fall in FEV1 of <8 mg/ml documented at any time during previous assessments at Glenfield Hospital.
3. A history of 2 or more asthma exacerbations in the previous 12 months requiring oral corticosteroids on at least 3 consecutive days, emergency care visit and treatment or hospitalisation.
4. Evidence of eosinophilic airway inflammation - a sputum eosinophil count of greater than 3% in last 2 years.
5. Ability to give written informed consent prior to participation in the study.
6. Availability to complete the study and all measurements.
7. Ability to read, comprehend and write English at a level sufficient to complete study related materials.
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
1. Current smokers or ex smokers with a smoking history of greater than 15 years.
2. Evidence of previous exposure to parasite disease, based on positive parasite serology.
3. History of allergy to antibody therapy.
4. History of an exacerbation or an escalation of treatment in the 2 weeks prior to baseline assessments. Participants can be recruited once they have been stable for at least 2 weeks.
5. History of alcohol or drug abuse.
6. Significant co morbidity pertaining to ischaemic heart disease, severe psychiatric disease and more than two bacterial respiratory tract infections in the last year.
7. Pregnant and lactating females or those women of child bearing potential who do not wish to practice recommended effective contraceptive measures for the duration of the trial period and 100 days after completing the trial. All women of child bearing potential will be required to have a negative pregnancy test prior to study entry.
8. Unexplained abnormal blood tests at screening that are considered a contra indication to proceeding with the trial by the principal investiagtor.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method