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Trial registered on ANZCTR


Registration number
ACTRN12607000494437
Ethics application status
Not yet submitted
Date submitted
25/09/2007
Date registered
27/09/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study of the Safety and Effectiveness of Chitin Microparticles (CMP) Nasal Spray in people with 'hay fever' due to spring allergy.
Scientific title
A Study of Chitin Microparticles (CMP) in Subjects with Seasonal Allergic Rhinitis to Evaluate Safety and Efficacy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seasonal Allergic Rhinitis. 2399 0
Condition category
Condition code
Inflammatory and Immune System 2503 2503 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two sprays in each nostril of CMP 0.5% Nasal spray, three times a day for four weeks.
Intervention code [1] 2122 0
Treatment: Drugs
Comparator / control treatment
Two sprays in each nostril of Placebo Nasal spray, three times a day for four weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 3399 0
Change from baseline in the 4 symptom nasal score for the entire double-blind treatment period.
Timepoint [1] 3399 0
Visit 4 (End of Treatment).
Secondary outcome [1] 5637 0
Physician and Subject Global Assessment.
Timepoint [1] 5637 0
Visit 4 (End of Treatment).
Secondary outcome [2] 5638 0
Morning instantaneous 4 symptom nasal score.
Timepoint [2] 5638 0
Visit 4 (End of Treatment).
Secondary outcome [3] 5639 0
Evening reflective 4 symptom nasal score.
Timepoint [3] 5639 0
Visit 4 (End of Treatment).
Secondary outcome [4] 5640 0
Ocular symptoms score.
Timepoint [4] 5640 0
Visit 4 (End of Treatment).
Secondary outcome [5] 5641 0
Night time sleep quality.
Timepoint [5] 5641 0
Visit 4 (End of Treatment).
Secondary outcome [6] 5642 0
Sneeze count.
Timepoint [6] 5642 0
Visit 4 (End of Treatment).
Secondary outcome [7] 5643 0
Severity of Lower respiratory tract symptoms.
Timepoint [7] 5643 0
Visit 4 (End of Treatment).
Secondary outcome [8] 5644 0
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Timepoint [8] 5644 0
Visit 4 (End of Treatment).
Secondary outcome [9] 5645 0
Quantity of Rescue medication that is used each time.
Timepoint [9] 5645 0
Visit 4 (End of Treatment).
Secondary outcome [10] 5646 0
Symptom free days.
Timepoint [10] 5646 0
Visit 4 (End of Treatment).
Secondary outcome [11] 5647 0
Safety measures (e.g. Adverse Events, vital signs (blood pressure, pulse rate and body weight measurements), number of subjects inside and outside the normal ranges of laboratory parameters, physical examinations, Electrocardiogram (ECG).
Timepoint [11] 5647 0
Visit 4 (End of Treatment).

Eligibility
Key inclusion criteria
Subjects, male or female, must be between the ages of 15 to 60 years inclusive at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at Screening and is routinely using adequate contraception prior to and during the trial and agrees not to attempt to become pregnant during the trial.
Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the treatment regimen and study procedures described in this protocol.
Subjects must have a documented history of SAR for at least 2 years prior to the Screening Visit against pollen from the geographical area of the study site, as diagnosed by the Investigator or another physician.
Subjects must have a documented sensitivity to one or more of the relevant seasonal allergens for the geographical area by an allergy skin test (prick) performed within the last 12 months of Visit 1. If this is not available it must be performed at Visit 1
At Visit 1 the subjects must have an average score of at least 1.5 in the 4 symptom nasal score.
At Visit 2 the subjects must have an average score of at least 1.5 in the 4 symptom nasal score calculated from the assessments documented in the diary during the last 3 days (including the assessment in the morning before Visit 2).
The subject must show symptoms of seasonal allergic rhinitis at Visit 2.
Minimum age
15 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with a known sensitivity to chitin, shellfish or any of the excipients in the study drug formulation.
Subjects who have used an investigational drug within 30 days prior to screening, or who are currently participating in another clinical study. Subjects with a current or past history (within the last 12 months) of alcohol or drug abuse.
Subjects with a history of asthma, with the exception of mild intermittent asthma (per the 1997 National Asthma Education and Prevention Program (NAEPP) guideline on asthma severity scale)
Documented evidence of acute or significant chronic sinusitis, as determined by the investigator.
Subject with perennial allergic rhinitis who has symptoms throughout the year defined as symptomatic on more than 50% of days during the last year as self reported by the subject. Subjects who have any clinically significant abnormal physical examination or laboratory results that, in the opinion of the Investigator, would put the subject at increased risk by participation in the study.
Subjects who have received a vaccination within 30 days prior to the screening visit or who intend to receive a vaccination during the study.
Subjects with congenital or acquired immunodeficiency including subjects known to be positive for Human Immunodeficiency Virus (HIV).
Subjects on chronic anti inflammatory or immunosuppressive therapy, with chronic autoimmune or inflammatory disease or with otherwise compromised immune system.
Subjects who have a medical condition which, in the opinion of the Investigator, would put the subject at increased risk by participation in the study or prevent them from completing the study, e.g. history or current confirmation of clinical abnormality of the hepatic or renal system.
Subjects who have received any of the following medications, within the time frame specified prior to screening (Visit 1), or are likely to require these medications during the study.
Within two years to screening:
Any anti-allergy immunotherapy (desensitizing subjects with increase of allergen challenge)
Within one month prior to screening:
Chronic or intermittent use of inhaled, oral, intramuscular, intravenous, and/or potent or super-potent topical corticosteroids
Long acting anti-histamines
HIV protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir);
Potent inhibitors of P450 cytochrome CYP 3A4
Within seven days prior to screening: Cetirizine, fexofenadine HCL, all other antihistamines (includes sleep and diet aids and cold preparations).

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)
Participants will be given a unique screening number consisting of a one digit site number and a three digit sequential patient identifier, e.g. 2010 for subject number ten at site number 2. Subjects will receive the lowest randomisation number available at the site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
400 sequential patients numbered from 001 to 400 in an unstratified randomisation with a fixed block size created in SAS v9.1 using the Ranuni function.
Masking / blinding
Blinded (masking 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
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 264 0
3145
Recruitment postcode(s) [2] 265 0
4021
Recruitment postcode(s) [3] 266 0
4075
Recruitment postcode(s) [4] 267 0
2228
Recruitment postcode(s) [5] 268 0
2050

Funding & Sponsors
Funding source category [1] 2650 0
Commercial sector/Industry
Name [1] 2650 0
Anzamune Limited, NZ
Country [1] 2650 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Anzamune Limited, NZ
Address
Level 2
6 Kitchener Street
Auckland
Country
New Zealand
Secondary sponsor category [1] 2399 0
Commercial sector/Industry
Name [1] 2399 0
Novotech (Australia) Pty Ltd
Address [1] 2399 0
Level 3
19 Harris Street
Pyrmont NSW 2009
Country [1] 2399 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4569 0
Ethics committee address [1] 4569 0
Ethics committee country [1] 4569 0
Date submitted for ethics approval [1] 4569 0
01/08/2007
Approval date [1] 4569 0
Ethics approval number [1] 4569 0

Summary
Brief summary
This study will evaluate the safety (i.e. incidence and type of adverse events) and efficacy (i.e. change from baseline in the 4 symptom nasal score for the entire double-blind treatment period) of CMP administered three times daily intranasally over a four week period to people with seasonal allergic rhinitis (SAR) as compared to placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28072 0
Address 28072 0
Country 28072 0
Phone 28072 0
Fax 28072 0
Email 28072 0
Contact person for public queries
Name 11229 0
Sharon Parkes
Address 11229 0
Novotech (Australia) Pty Ltd
Level 3
19 Harris St
Pyrmont NSW 2009
Country 11229 0
Australia
Phone 11229 0
+61 2 85691400
Fax 11229 0
+61 2 95189390
Email 11229 0
[email protected]
Contact person for scientific queries
Name 2157 0
Stuart J. McLachlan
Address 2157 0
SJM Associates Limited
Kuku Road R D 14
Ashhurst 4884
Country 2157 0
New Zealand
Phone 2157 0
+64 6 329 4846
Fax 2157 0
+64 6 329 4848
Email 2157 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

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