Asthma Respiratory Asthma
Conditions
Interventions
Screen visit 1:
Informed consent will be obtained before screening starts. Suitable subjects will undergo full assessment of their medical history (including a complete smoking history) and laboratory
Sponsors
King?s College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adults aged between 18 to 65 years 2. Documented history and typical symptoms of asthma for greater than or equal to 6 months prior to screening 3. Pre-bronchodilator forced expriatory volume in one second (FEV1) less than 70% predicted and greater than 15% reversibility to beta 2-agonist or diurnal peak flow variability of greater than 20% 4. Corticosteroid refractory asthma, as defined by a less than 15% improvement in FEV1 following a 14-day course of prednisolone 40 mg/1.73 m^2/days 29 - 31 5. Written informed consent received
Exclusion criteria
Exclusion criteria: 1. Past or present disease, which, as judged by the investigator, may affect the study outcome (other than asthma, rhinitis or eczema) 2. Serum corrected calcium greater than 2.66 mmol/l 3. Clinically significant deviation from normal (physical examination or laboratory parameters) as judged by the investigator at the screening visit 4. Current smoker or an ex-smoker of less than 5 years with a greater than 5 pack year history 5. Pregnant or lactating females or those at risk of pregnancy (women of childbearing age may be offered a pregnancy test prior to recruitment) 6. History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks of the screening visit requiring oral corticosteroid tablets 7. Participation in a study involving an investigational medicinal product in the previous 3 months or blood donation within the last year 8. Participants taking regular medications for diseases other than those for asthma or rhinitis 9. Current or previous allergen immunotherapy 10. Concomitant treatment with a thiazide diuretic or calcium supplement 11. Inability to understand or comply with the research protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FEV1 at baseline compared to the end of the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Level of the ex-vivo production of interleukin-10 (IL-10) and other surrogate biomarkers of outcome or drug effects/process by T-cells, measured at screen visit 1, screen visit 2, treatment visit day 1, treatment visit day 15 and treatment visit day 28 2. Serological markers of inflammation, measured at screen visit 1, screen visit 2, treatment visit day 1, treatment visit day 15 and treatment visit day 28 3. Fraction of nitric oxide in exhaled air, measured at screen visit 1, screen visit 2, treatment visit day 15 and treatment visit day 28 4. Asthma Control Questionnaire (ACQ) score, measured at treatment visit day 15 and treatment visit day 28 | — |
Countries
United Kingdom
Outcome results
None listed