EPI-12323 for the treatment of symptomatic moderate to severe asthma
- Conditions
- Symptomatic moderate to severe asthmaRespiratory - Asthma
- Registration Number
- ACTRN12607000192482
- Lead Sponsor
- Epigenesis Pharmaceuticals, LLC, USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 214
Asthma Diagnosis: Patients must have a documented history of chronic asthma for at least the past one (1) year. Prior Asthma Medications: Documented use for at least 30 days prior to screening of inhaled short-acting beta 2-agonists. At the time of screening patients must be on at least 800 ucg budesonide (or >500 ucg fluticasone/day) for at least 3 months prior to screening or inhaled corticosteroids with a long acting beta-agonist (ICS + LABA) combination with a dose of at least 500 ucg fluticasone or at least 800 ucg of budesonide/day In-clinic FEV1 values must be greater than or equal to 60% of predicted normal following a 6 hour salbutamol withhold or a 12 hour long acting beta-agonist withhold Patients must be non-smokers for at least the past year and have less than a 10 pack-year smoking history. Patients must sign and date an informed consent prior to any study procedures. Patients must be able to complete diariesMales must have a Prostate specific antigen (PSA) <4.0 ng/mL on screening.
In-clinic FEV1 <60% of predicted normalHistory of life-threatening asthma No use of injectable or oral corticosteroids within 3 months prior to screening. Patients must be withdrawn from leukotriene receptor antagonists, 5 Lipoxygenase (LO) inhibitors or methylxanthines for at least two weeks prior to starting this study. Patients must be withdrawn from injectable anti-IgE therapy for at least 6 months prior to randomization. Patients must withdraw from inhaled methacholine antagonists or cromones for one week prior to screening.Patients must be withdrawn from bisphosphonates and calcitonin for at least 3 months prior to screening.Patients may not be on selective estrogen receptor modifiers (SERMs) ie 'Evista', for at least one month prior to screening Previous participation in an investigational drug trial within 30 days of Screening.Only one member of the immediate household may participate in the trial. Pregnant or lactating femalesPatients with a serious concomitant disease such as cancer or serious renal, hepatic, cardiac, immunodeficiency, neurological, psychiatric, or other disease;Patients who have had an upper respiratory tract infection within 4 weeks of screening;Other protocol defined exclusions apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Asthma control [Assessed as change from baseline at six weeks]
- Secondary Outcome Measures
Name Time Method Asthma control[Weekly for 6 weeks after randomization];Pulmonary function: Forced expiratory volume. The volume of air expelled in the first second of maximal forced expiration from a position of full inspiration (FEV1) <br>Peak Expiratory Flow Rate (PEFR)[Weekly for 6 weeks after randomization];Asthma quality of life[Change from baseline at six weeks];Safety: <br> Adverse events, withdrawals each assessed weekly for 6 weeks<br> Safety laboratory, Electrocardiogram (ECG) each assessed at weeks 2 and 6 <br> Endocrine function assessed as changed from baseline at 6 wks[];Pharmacokinetics[Assessed as change from baseline at 6 weeks]