Mild asthma
Conditions
Interventions
Product Name: GW274150 Tablets
Product Code: GW274150
Pharmaceutical Form: Tablet
Current Sponsor code: GW274150F
Concentration unit: mg
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18 to 55 years inclusive. Women must be of non-childbearing potential. Women will only be considered for inclusion if they have documented proof of hysterectomy or tubal ligation, or meet the criteria for menopause and have been amenorrhoeic for more than 1 year. 2. Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta-agonist therapy by inhalation. 3. Pre-bronchodilator FEV1 >65% of predicted at screening. 4. Documented sensitivity to AMP with a provocative concentration of AMP resulting in a 20% fall in FEV1 (PC20 AMP) of less than 100 mg/mL at screening. 5. Documented sensitivity to methacholine with a provocative concentration of methacholine resulting in a 20% fall in FEV1 (PC20 methacholine) of =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, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis). 2. Clinically significant abnormalities in safety laboratory analysis at screening. 3. Subject has known history of hypertension or is hypertensive at screening. Hypertension at screening is defined as persistent systolic BP >140mmHg or diastolic BP > 90mmHg. 4. Known hypersensitivity to Singulair. 5. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication. 6. History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures. 7. Administration of oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of treatment with repeat oral doses of GW274150 for 14 days on the late asthmatic response (LAR) to inhaled allergen in mild asthmatic subjects compared with placebo ; Secondary Objective: 1. To evaluate the effect on bronchial hyper-reactivity in response to methacholine challenge following allergen challenge. 2. To evaluate the effect on bronchial hyper-reactivity in response to AMP challenge. 3. To evaluate the effect on the early asthmatic response (EAR) after allergen challenge. 4. To evaluate the effect on concentrations of exhaled nitric oxide. 5. To assess the safety and tolerability. 6. To evaluate the effect on established markers of inflammation and iNOS activity in blood, BAL and bronchial biopsy. ; Primary end point(s): Late Asthmatic Response (LAR): minimum FEV1 between 4-10 hours after allergen challenge on Day 14 of each treatment period | — |
Countries
United Kingdom
Outcome results
None listed