Asthma and Allergic Rhinitis MedDRA version: 12.0 Level: LLT Classification code 10003553 Term: Asthma MedDRA version: 12.0 Level: LLT Classification code 10001723 Term: Allergic rhinitis
Conditions
Interventions
Product Name: SMP-028
Product Code: SMP-028
Pharmaceutical Form: Tablet
INN or Proposed INN: SMP-028
Current Sponsor code: SMP-028
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
Dainippon Sumitomo Pharma Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male subjects and females of non-child bearing potential (e.g. post-menopausal (no menstrual bleeding for at least the preceding 12 months) or surgically sterilised), between 18 and 65 years of age inclusive. •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. •Pre-bronchodilator FEV1 >65% of predicted at Screening. •Demonstration of a positive wheal reaction (= 3 mm relative to negative control) to at least one of three allergens (house dust mite, grass pollen, cat hair and dander) on skin prick testing at Screening, or within 12 months of study start. •Screening allergen challenge demonstrating that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of = 20% from the post-saline or diluent value, on at least 1 occasion, between 5 and 30 minutes after the final concentration of allergen. The late asthmatic response must include a fall in FEV1 of = 15% from the post-saline or diluent value, on at least 3 occasions, 2 of which must be consecutive, between 4 and 10 hours after the final concentration of allergen. •Sensitivity to AMP with a provocative concentration of AMP resulting in a 20% fall in FEV1 (PC20 AMP) of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: •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). •Subject has known history of uncontrolled hypertension or is hypertensive at Screening. Hypertension at Screening is defined as persistent systolic blood pressure (BP) >150mmHg or diastolic BP > 90mmHg. Subjects with well controlled essential hypertension may be enrolled provided that their antihypertensive medication(s) are permitted. •Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study drug. •Symptomatic allergic rhinitis (those with a history of allergic rhinitis may participate if asymptomatic at Screening and if, in the opinion of the Investigator, it is unlikely that disease exacerbation will occur during the course of the study. •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. •Administration of oral, injectable or dermal steroids within 3 months and/or inhaled steroids within 1 month of the Screening Visit. •Has taken Xanthines (including theophylline, but not including caffeine), anticholinergics, cromoglycates and/or long-acting beta-agonists within 1 week prior to Screening and is unable to abstain from them throughout the study. •History of being unable to tolerate or complete AMP or allergen challenge tests. •If on more than two occasions, after 2 concurrent administrations of saline during the allergen challenge at Screening the subjects still have a fall in FEV1 of greater than 10%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the effect of treatment with repeat doses of SMP-028 on the late asthmatic response (LAR) to inhaled allergen challenge in mild to moderate asthmatic subjects. ;Secondary Objective: In mild to moderate asthmatic subjects: •To evaluate the effect of treatment with repeat doses of SMP-028 on the early asthmatic response (EAR) to inhaled allergen challenge •To evaluate the effect of treatment with repeat doses of SMP-028 on lung function as measured by FEV1 on Day 13. •To evaluate the effect of treatment with repeat doses of SMP-028 on exhaled NO on Days 13 and 14. •To evaluate the effect of treatment with repeat doses of SMP-028 on bronchial hyper-reactivity as measured by AMP challenge on Day 14. •To evaluate the effect of treatment with repeat doses of SMP-028 on induced sputum post- allergen challenge on Day 14. •To assess the safety and tolerability of treatment with repeat doses of SMP-028. •To evaluate the multiple dose PK of SMP-028 and its M3 and M5 metabolites.;Primary end point(s): •Mean baseline-corrected area under the FEV1 reduction curve from 4 to 10 hours after allergen challenge (AUC4-10h) on Day 13 of each treatment period. | — |
Countries
United Kingdom
Outcome results
None listed