Asthma
Conditions
Interventions
Product Name: CEP-1347 5 mg
Pharmaceutical Form: Capsule, hard
CAS Number: 156177-65-0
Current Sponsor code: CEP-1347
Other descriptive name: LU 02-648/KT-7515
Concentration unit: mg milligram(s)
Conc
Sponsors
deCODE genetics ehf.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The criteria listed below will be assessed at Visit 1 unless stated otherwise. Laboratory measurements to be performed require an overnight fasting =8 hours in duration. 1. Age =18 years and =75 years. 2. Carrier of MAP3K9 haplotype (based on results of previous deCODE genetics’ studies, to be confirmed by analysis of a blood sample collected at Visit 2). 3. Physician diagnosis of persistent mild, moderate or severe asthma as defined by the NIH 1997 guidelines. 4. Lung function measurements (spirometry, airway challenge test or peak expiratory flow (PEF) reading) consistent with the diagnosis of mild persistent, moderate or severe asthma. 5. Confirmed airway reversibility of ?12% FEV1 using a ß-adrenergic agonist and/or positive metacholine airway challenge test (=8 µg/ml). In selective cases, the screening physician can omit this requirement if prior medical history indicates significant reactive airway disease. 6. FEV1 values =45% of predicted value at baseline. 7. Regular use of inhaled glucocorticoid drugs (such as budesonide, fluticasone, mometasone, beclomethasone) with or without long-term beta-agonist drugs (such as salmeterol or formoterol) in accordance with standard practice of care. 8. Males and post-menopausal women are not required to use contraception. Only those women of childbearing potential willing to use two adequate methods of contraception or willing to abstain from heterosexual activity throughout the study, starting with Visit 1 and for 14 days after the last dose of study medication are eligible for the study. Refer to section 13.6.2 for information on adequate contraceptive methods. Note: Women of childbearing potential are defined as premenopausal, not having had surgical sterilisation (hysterectomy or bilateral tubal ligation or bilateral oophorectomy). Postmenopausal status is defined as =45 years of age with >2 years since last menses. 9. Signed and dated informed consent form prior to any protocol specific procedures. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Individuals are excluded from participation in the study if they meet any of the following criteria at Visit 1: 1. Confirmed diagnosis of chronic obstructive pulmonary disease (COPD). 2. Subject unable to perform acceptable spirometry and peak flow measurements. 3. Any experimental treatment within 2 months of screening or planned for the following 3 months. 4. Smoking history =15 pack-years and any smoker who has smoked within the previous 6 months. 5. Recent severe exacerbation of asthma (4 weeks). 6. Abnormal liver function tests (LFTs), including ALT >3×ULN; AST >3×ULN; bilirubin >2×ULN. 7. Serum creatinine >1.8×ULN. 8. Oral corticosteroids within the previous 4 weeks. 9. Active infection requiring antibiotic therapy within the past 2 weeks. 10. Subjects receiving desensitisation immunotherapy. 11. Immunocompromised subjects, including subjects known to be HIV positive. 12. Subjects known to have positive serology results for HBsAg, HCV Ab. 13. Major surgery within 6 weeks of study entry. 14. Patients with any history of seizure disorders or posttraumatic epilepsy. 15. Subjects not willing to adhere to restrictions of alcohol use for the duration of the study (=3 units of alcohol/day or =15 units of alcohol/week and no alcohol for 24 hours prior to clinic visits). Note: A unit of alcohol is defined as a single measure of spirit (25 ml), one small glass of sherry or fortified spirit (50 ml), one small glass of wine (125 ml) or one small regular strength beer (330 ml, 4-5%). 16. Known or suspected hypersensitivity to any component of the study medication, including placebo. 17. Any other major intercurrent illness and other condition which, in the investigator’s judgement, will interfere with the subject’s participation in this study. 18. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine the effects of therapy with CEP-1347 in asthma as measured by: a) improvement in clinical asthma score and/or lung function tests (PEF, FEV1, FEV1/FVC or FEF25-75, or MCT). b) Reduction in eNO (exhaled nitric oxide) and/or cytokine markers in sputum (IL-6/IL-8). 2. To assess the safety and tolerability of CEP-1347 10 mg, 25 mg or 50 mg b.i.d. in patients with asthma compared to placebo.;Secondary Objective: 1. To determine if the above effects of CEP-1347 in asthma are dose-dependent. 2. To determine the effects of CEP-1347 on the need for rescue therapy and/or concomitant medications. 3. To determine the effects of CEP-1347 on preventing pulmonary exacerbations. 4. To determine the effects of CEP-1347 on improving quality of life as assessed by the SF-36 health survey. 5. To evaluate pharmacokinetic parameters of CEP-1347 in subjects 18-75 years of age (40 subjects). Refer to protocol for tertiary and exploratory objectives.;Primary end point(s): Safety: Incidence of adverse events and abnormal laboratory values. Efficacy: Improvement in clinical asthma score and/or lung function parameters relative to placebo. Reduction in eNO and/or cytokine markers in sputum. | — |
Countries
Iceland
Outcome results
None listed