Mild to moderate persistent asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: N/A
Product Code: OC000459
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: OC000459
Other descriptive name: ODC9101
PFGK001
5-Fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)-acetic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated ta
PFGK013
5-Fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)-acetic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated t
Sponsors
Oxagen Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at screening (visit 1) 1. Male or female asthmatics, any racial group. Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception (i.e. two of the following at the same time – oral contraception, barrier contraception, intrauterine device) and must have a negative pregnancy test (blood or urine) at screening. 2. Aged 18-55 years inclusive. 3. Non smokers for at least the past 12 months with a pack history 1 actuation/day over the last 7 days of the placebo run-in period; where day 7 is the day before randomisation (data to be collected by the Vitalograph® 2110 spirometer/e-diary and must have been entered on at least 4 of the 7 days). 4. Ability to give an adequate (see Study Reference Manual) home PEF test and to record salbutamol MDI usage correctly (data to be collected by the Vitalograph® 2110 diary) on at least 4 days out of 7 in each of the two weeks prior to randomisation. 5. Able to perform technically satisfactory respiratory function tests reliably both in clinic and with the Vitalograph 2110 spirometer/e-diary. 6. Able to use a salbutamol MDI reliably with the correct inhaler
Exclusion criteria
Exclusion criteria: 1. Positive salivary or urinary cotinine or Smokerlyzer test at screening. 2. Presence of any clinically significant respiratory disease other than a history of mild to moderate persistent asthma (e.g. chronic bronchitis, chronic obstructive pulmonary disease, emphysema, cystic fibrosis). 3. Exacerbation of asthma in the three months preceding the screening period requiring emergency treatment, intubation or oral or intravenous steroids. 4. History of desensitisation therapy or anti-IgE therapy in the past year. 5. Use of inhaled or systemic corticosteroids in the period from 28 days prior to screening until the final follow up visit of the trial. 6. Any infirmity, disability, or geographic location which, in the opinion of the principal investigator, would limit compliance with the protocol. 7. Clinical evidence of lower respiratory tract infection requiring a course of antibiotics in the month (28 days) prior to screening or during screening. 8. The subject has participated in a study with a new molecular entity during the previous four months or any other trial during the previous three months. 9. The subject regularly, or on average, drinks more than four units of alcohol per day and/or uses drugs of abuse. 10. The subject has a history of testing positive for hepatitis C antibody or hepatitis B surface antigen or for HIV. 11. The subject has a history of gastrointestinal disorder likely to influence drug absorption. 12. A history of hypersensitivity and/or idiosyncrasy to any of the test compounds including formulation components employed in this study. 13. Any previous clinical trial involving the administration of OC000459. 14. Any diagnosis of cancer within five years of accrual to the study. 15. Any psychiatric disorder that would impair the subject’s ability to give written informed consent or to comply with the requirements of the study. 16. Receipt of prescribed or over the counter medication within 14 days prior to the first study day (first day of the placebo run in period) and for the duration of the trial (until the final follow up visit), including vitamins with the exception of salbutamol MDI (salbutamol MDI will be supplied by the Sponsor for use during the trial) and up to 2 g of paracetamol daily as well as short acting antihistamines for the treatment of allergic rhinitis (with the prior agreement of the investigator). Hormone replacement therapy such as insulin for insulin dependent diabetes mellitus, hormone replacement therapy for women going through the menopause and thyroxine for hypothyroidism is also allowed. The oral contraceptive pill is also allowed for women of child bearing potential. In particular, ketoconazole, all non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or asthma medications such as theophylline, disodium cromoglycate, leukotriene antagonists, steroids, anticholergics or long acting beta-2 agonists are prohibited during the trial period. 17. Active tuberculosis present in any organ, according to medical history. 18. Churg-Strauss syndrome. 19. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the efficacy of three oral dose schedules of OC000459 (leading to > or = 8% improvement in clinic FEV1 over placebo) over a treatment period of 12 weeks;Secondary Objective: • To assess the effects of three oral dose schedules of OC000459 in comparison to placebo on the Asthma Control Questionnaire1,2 (ACQ) and the Standardised Asthma Quality of Life Questionnaire3 (AQLQ(S)). • To investigate the effects of three oral dose schedules of OC000459 in comparison to placebo on clinic PEF and FEV1 and Vitalograph® 2110 spirometer/e-diary information on PEF, asthma symptoms and salbutamol MDI usage in this population. • To assess the safety and tolerability of three oral dose schedules of OC000459 ;Primary end point(s): The primary objective of the study is to assess the effects of three dosing regimens of OC000459 in comparison to placebo on respiratory function (FEV1) in asthmatics with an FEV1 of 60-85% of predicated at baseline. The primary analysis will be based on the clinic assessments taken before the morning dose, planned to be at least 6 hours since the last use of salbutamol MDI. The average change from baseline over the double-blind treatment will be analysed using ANOVA with treatment, centre and sex as factors; and baseline FEV1 (average of visits 4 and 5) and age as covariates. The primary analysis, based on the full analysis set of subjects, will include all subjects who have a baseline FEV1 and at least one FEV1 assessment during the double blind treatment phase. The primary comparisons of interest will be of each of the active treatment groups against placebo. Tests will use a 1.67% level of significance, using a Bonferroni adjustment to protect for multiple comparisons. In addition, the change and percentage change in FEV1 will be summarised at each visit during the double blind treatment period and at the end of the washout, together with an LOCF to the end of the double-blind treatment period summary. These summaries will | — |
Countries
Bulgaria, Hungary
Outcome results
None listed