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Trial registered on ANZCTR


Registration number
ACTRN12608000140358
Ethics application status
Approved
Date submitted
12/03/2008
Date registered
18/03/2008
Date last updated
18/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Open-Label, Multi-Center, Randomized Study Evaluating the Safety and Efficacy of Flutcasone Propionate Nasal Drops, Nasal Spray and Suspension for Nebulization via Nasal Inhalation in Post-Surgical Subjects with Chronic Sinusitis
Scientific title
A randomised controlled trial evaluating the safety and efficacy of Flutcasone Propionate Nasal Drops, Nasal Spray and Suspension for Nebulization in post-surgical participants with chronic sinusitis
Secondary ID [1] 530 0
Naryx Pharma, Inc: NRYX-FLUT-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Sinusitis 2924 0
Condition category
Condition code
Inflammatory and Immune System 3060 3060 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) Flixonase Nasule Drops one nasule per day for both nostrils 400 mcg per day for 4 wks b) Beconase Allergy & Hayfever 24 Hour nasal spray 2 spays per nostril twice per day 400 mcg/day for four weeks c) Flixotide Nebules 2 mg/mL nebule, via nasal inhalation once per day 400 mcg/day for four weeks
Intervention code [1] 2653 0
Treatment: Drugs
Comparator / control treatment
There are no control treatments.
Control group
Active

Outcomes
Primary outcome [1] 3943 0
Comparison from the change of baseline (entry) in the average Subject-Rated Total Sinus Symptom Score during the fourth (last) week of therapy for each method of administration
Timepoint [1] 3943 0
Measured at Days -13 to 0, days 1, 15, 29 and 36.
Secondary outcome [1] 6624 0
Number of percentage of participants experiencing improvement at Day 29 (Treatment period) based on the Physician-Rated Global Improvement Score
Timepoint [1] 6624 0
Day 29

Eligibility
Key inclusion criteria
Changes from baseline in weekly average sum scores for the subject rated sinus symptoms of nasal congestion, post-nasal drip, and one of the following symptoms (identified as the worst at Screening): facial or sinus pain, facial or sinus pressure, or sinus headache; during the fourth week of therapy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Females who are either pregnant, breastfeeding or of child bearing potential not using adequate birth control.
2. Evidence of infection by purulent drainage from an open sinus cavity visualized by nasal endoscopy 3. Nasal polyposis causing obstruction of any open sinus cavity rending them inaccessaible to endoscopic exam 4. Known allergy or hypersensitivity of fluticasone propionate or any of the formulation components of the product. 5. any disease or condition requiring corticosteroid therapy 6.Any use of antibiotics or anti-fungals, decongestants and/or antihistamines within the past 7 days prior to randomization 7. Any condition that would make the administration of fluticasone propionate clinically inadvisable 8. Use of any systemic corticosteroids within the past 30 days prior to screening 9. Use of nasal or inhaled corticosteroids within the past 14 days prior to randomization 10. Use of mast cell or leukotriene inhibitors when necessary within the past 14 days prior to randomization

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)
Allocation was concealed by central randomization via computer-generated schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized to one of three treatment groups in accordance with a computer-generated randomization schedule by a study statistician. Once a subject is eligiable for randomization, he/she will be assigned the appropriate treatment arm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 606 0
3002
Recruitment postcode(s) [2] 607 0
5000

Funding & Sponsors
Funding source category [1] 3177 0
Commercial sector/Industry
Name [1] 3177 0
Naryx Pharma, Inc.
Address [1] 3177 0
Suite A
5464 Carpinteria Avenue
Carpinteria CA 93013
Country [1] 3177 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Naryx Pharma, Inc.
Address
Suite A
5464 Carpinteria Avenue
Carpinteria CA 93013
Country
United States of America
Secondary sponsor category [1] 2848 0
Commercial sector/Industry
Name [1] 2848 0
Trident Clinical Research
Address [1] 2848 0
Trident House
124 Lipson Street
Port Adelaide South Australia 5015
Country [1] 2848 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5159 0
Royal Victorian Eye and Ear Hospital (RVEEH) Human Research and Ethics Committee
Ethics committee address [1] 5159 0
RVEEH Human Research and Ethics Committee
32 Gisborne Street
East Melbourne Victoria 3002
Ethics committee country [1] 5159 0
Australia
Date submitted for ethics approval [1] 5159 0
Approval date [1] 5159 0
16/04/2007
Ethics approval number [1] 5159 0
07/751H
Ethics committee name [2] 5161 0
Royal Adelaide Research Ethics Committe
Ethics committee address [2] 5161 0
RAH Research Ethics Committee
Level 3
Hanson Institute
North Terrace
Adelaide South Australia 5000
Ethics committee country [2] 5161 0
Date submitted for ethics approval [2] 5161 0
Approval date [2] 5161 0
17/07/2007
Ethics approval number [2] 5161 0
070622

Summary
Brief summary
This is a multi-center, randomized, parallel-group, open-label, 2 treatment group study to evaluate the safety and efficacy of Fluticasone Proprionate Nasal Drops, Nasal Spray and Suspension for Nebulization via Nasal Inhalation for the treatment of chronic sinusitis in post-surgical subjects 18 years of age and older.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28434 0
Address 28434 0
Country 28434 0
Phone 28434 0
Fax 28434 0
Email 28434 0
Contact person for public queries
Name 11591 0
Elsi Mathews, Clinical Project Manager
Address 11591 0
Naryx Pharma, Inc.
Suite 3203760
4225 Executive Square
La Jolla CA 9
Country 11591 0
United States of America
Phone 11591 0
8584584200 ext. 231
Fax 11591 0
8584584350
Email 11591 0
emathews@naryxpharma.com
Contact person for scientific queries
Name 2519 0
Dr. Minh Pham
Address 2519 0
Trident Clinical Research
124 Lipson Street
Port Adelaide South Australia 5015
Country 2519 0
Australia
Phone 2519 0
+61 8 84473500
Fax 2519 0
+61 8 84473511
Email 2519 0
mpham@tridentcr.com

No information has been provided regarding IPD availability
Summary results
No Results