EPI-12323 for the treatment of symptomatic moderate to severe asthma

A Randomized, Double-Blind, Parallel Study of the effects on asthma control of a Once Daily Dosing of EPI-12323 versus Placebo in Symptomatic Moderate to Severe Asthmatics on Low-Dose Inhaled Corticosteroids

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000192482

Acronym

Not applicable

Enrollment

214

Registered

2007-04-03

Start date

2007-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study examines the safety and the ability of a new asthma medicine, EPI-12323, to improve asthma control, pulmonary function and symptoms in patients with symptomatic moderate to severe asthma.

Interventions

Inhalation of EPI-12323 (35 mg/mL) + 400 ucg budesonide once daily for six weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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.

Exclusion criteria

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 Patients must be withdrawn from leukotriene receptor antagonists, 5 Lipoxygenase (LO) inhibitors or methylxanthines for at least two weeks prior to starting this study.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.

Outcome results