Moderate to severe asthma MedDRA version: 9.1 Level: LLT Classification code 10001705 Term: Allergic asthma
Conditions
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18 to 65 years inclusive. 2. Body mass index within the range 18.5-37.0 kilograms/metre2 (kg/m2). 3. An established clinical history of Asthma in accordance with the definition by the GINA Guidelines [GINA, 2006]. 4. Female subjects of childbearing and non childbearing potential 5. Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 3 months after the last dose. 6. Subject with moderate to severe asthma with a post bronchodilator FEV1 >/=50% of predicted for age and height. 7. Subject who are on regular inhaled corticosteroids without or in combination with a regular long acting Beta 2 Agonist. The dose should be stable for at least 4 weeks before screening. 8. Subjects who are taking a minimum of FP 250mg BID or equivalent 9. Persistent sputum neutrophilia defined by sputum neutrophils = 65% with TTC =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Past or present disease, which as judged by the investigator or medical monitor, may affect the outcome of this study. 2. Clinically significant abnormalities in safety laboratory analysis at screening. 3. Subject has uncontrolled hypertension or is hypertensive at screening. 4. History of asthma exacerbations or acute intercurrent respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) for a four week period before the screening visit. 5. History of life-threatening asthma, defined as an asthma episode that required intubations and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures. 6. Subject is unable to abstain from taking prescription or non-prescription drugs unless in the opinion of the Investigator and sponsor the medication will not interfere with the study. 7. Administration of oral or injectable steroids within 6 weeks of screening. 8. Administration of anti -leukotrienne therapies for 14 days before screening and during the study. 9. Subject is undergoing allergen desensitisation therapy. 10. Administration of OATP1B1 substrates from 2 weeks before dosing, and until all follow up assessments are completed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of treatment with repeat oral doses of GSK2190915 on the number of neutrophils in induced sputum in moderate to severe asthmatic subjects compared with placebo;Primary end point(s): The numbers of neutrophils in induced sputum (absolute and % count).;Secondary Objective: • To evaluate the effect of treatment on lung function as measured by FEV1 • To assess the safety and tolerability of repeat oral doses of GSK2190915 • To assess the systemic exposure of GSK2190915 after 12 days repeated doses • To evaluate the effect of treatment on LTE4 in urine and LTB4 in blood and sputum supernatant • To evaluate the effect of treatment on IL-17 in blood • To evaluate the effect of treatment on sputum supernatant including changes in neutrophil elastase, myeloperoxidase and IL-8 • To evaluate effect of treatment on changes in symptoms | — |
Countries
United Kingdom
Outcome results
None listed