Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000192482
Ethics application status
Not yet submitted
Date submitted
2/04/2007
Date registered
3/04/2007
Date last updated
31/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
EPI-12323 for the treatment of symptomatic moderate to severe asthma
Scientific title
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
Universal Trial Number (UTN)
Trial acronym
Not applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic moderate to severe asthma 1710 0
Condition category
Condition code
Respiratory 1803 1803 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inhalation of EPI-12323 (35 mg/mL) + 400 ucg budesonide once daily for six weeks
Intervention code [1] 1686 0
Treatment: Drugs
Comparator / control treatment
Inhalation of placebo (2 mL) + 400 ucg budesonide once daily for six weeks
Control group
Placebo

Outcomes
Primary outcome [1] 2523 0
Asthma control
Timepoint [1] 2523 0
Assessed as change from baseline at six weeks
Secondary outcome [1] 4356 0
Asthma control
Timepoint [1] 4356 0
Weekly for 6 weeks after randomization
Secondary outcome [2] 4357 0
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)
Peak Expiratory Flow Rate (PEFR)
Timepoint [2] 4357 0
Weekly for 6 weeks after randomization
Secondary outcome [3] 4358 0
Asthma quality of life
Timepoint [3] 4358 0
Change from baseline at six weeks
Secondary outcome [4] 4359 0
Safety:
Adverse events, withdrawals each assessed weekly for 6 weeks
Safety laboratory, Electrocardiogram (ECG) each assessed at weeks 2 and 6
Endocrine function assessed as changed from baseline at 6 wks
Timepoint [4] 4359 0
Secondary outcome [5] 4360 0
Pharmacokinetics
Timepoint [5] 4360 0
Assessed as change from baseline at 6 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central, ‘off-site’ randomization by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using computer generated sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The following are blinded in the study: the people receiving the study treatment, the people administering the treatment (researcher), the people assessing the outcomes (assessor) and the people analysing the results/data (data analyst). All except an unblinded study coordinator who dispenses the study treatment to the participant in the clinic will be blinded in the study.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
214
Accrual to date
Final
Recruitment outside Australia
Country [1] 505 0
United States of America
State/province [1] 505 0

Funding & Sponsors
Funding source category [1] 1957 0
Commercial sector/Industry
Name [1] 1957 0
Epigenesis Pharmaceuticals, LLC
Country [1] 1957 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Epigenesis Pharmaceuticals, LLC, USA
Address
Country
United States of America
Secondary sponsor category [1] 1767 0
Commercial sector/Industry
Name [1] 1767 0
Novotech (Australia) Pty Ltd
Address [1] 1767 0
Country [1] 1767 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3652 0
Lung Institute of Western Australia
Ethics committee address [1] 3652 0
Ethics committee country [1] 3652 0
Australia
Date submitted for ethics approval [1] 3652 0
Approval date [1] 3652 0
Ethics approval number [1] 3652 0
Ethics committee name [2] 3653 0
Sir Charles Gairdner Hospital
Ethics committee address [2] 3653 0
Ethics committee country [2] 3653 0
Australia
Date submitted for ethics approval [2] 3653 0
Approval date [2] 3653 0
Ethics approval number [2] 3653 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27789 0
Address 27789 0
Country 27789 0
Phone 27789 0
Fax 27789 0
Email 27789 0
Contact person for public queries
Name 10875 0
Dr Rhada Jha
Address 10875 0
Novotech (Australia) Pty Ltd
Level 3, 19 Harris St
Pyrmont, NSW, 2009
Country 10875 0
Australia
Phone 10875 0
+61 2 9518 9600
Fax 10875 0
+61 2 9518 9390
Email 10875 0
[email protected]
Contact person for scientific queries
Name 1803 0
Joanne Leonard
Address 1803 0
Epigenesis Pharmaceuticals
2009 Eastpark Boulevard
Cranbury NJ 08512
Country 1803 0
United States of America
Phone 1803 0
609-409-3033
Fax 1803 0
609-409-6126
Email 1803 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.