Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000026628
Ethics application status
Approved
Date submitted
18/12/2013
Date registered
9/01/2014
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of Carrageenan spray in the prevention of rhinovirus cold infection
Scientific title
A randomized placebo controlled trial of the preventative effects of Carrageenan nasal spray on reported cold infection symptoms and rhinovirus levels in the nose, when taken for 8 weeks by adults during cold season.
Secondary ID [1] 283803 0
Nil
Universal Trial Number (UTN)
U1111-1151-5174
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of rhinovirus cold infection 290747 0
Condition category
Condition code
Respiratory 291106 291106 0 0
Other respiratory disorders / diseases
Infection 291221 291221 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A nasal spray containing saline solution and 1.6 mg/ml carrageenan will be taken by participants in the active group during cold season. Each participant will take one spray into each nostril 3 times each day for 8 weeks. The participants will take a daily record of cold symptoms and a nasal swab will be taken at the beginning and end of the study, as well as when cold symptoms develop, to ascertain levels of rhinovirus in the nose.
Intervention code [1] 288456 0
Prevention
Comparator / control treatment
A nasal spray containing saline solution will be taken by participants in the placebo group during cold season. Each participant will take one spray into each nostril 3 times each day for 8 weeks. The participants will take a daily record of cold symptoms and a nasal swab will be taken at the beginning and end of the study, as well as when cold symptoms develop, to ascertain levels of rhinovirus in the nose.
Control group
Placebo

Outcomes
Primary outcome [1] 291094 0
Reduction in cold symptoms in recorded cold symptom diaries in the active group over an 8 week time period
Timepoint [1] 291094 0
8 weeks
Secondary outcome [1] 305993 0
Lower levels of rhinovirus positive nasal swabs in the active group compared to the placebo group
Timepoint [1] 305993 0
8 weeks

Eligibility
Key inclusion criteria
At least one cold infection reported in the previous year
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not using any other nasal sprays during the study period
Previous sensitivity to carrageenan spray.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Our current HRC programme He Kainga Oranga/Community Housing and Health Intervention Research Programme (12/1071) examines whether simple bedroom interventions can reduce the incidence of rhinovirus infection in children, and involves collection of a two month Upper Respiratory Tract Infection (URTI) symptom diary from each child over winter with viral swabs taken at the beginning and end of the period. The parents from this study will be asked to participate in this double-blinded randomised controlled trial of Iota Carrageenan. Allocation concealment will be by central computer randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will occur by using using a randomisation table created by computer software, applied at the time of recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
In the parental age group 20-45 years, the frequency of reported respiratory illness is 2-3 episodes per year, most of which are likely to occur during the peak rhinovirus months of autumn, winter and spring. Assuming that 75% of parents develop cold symptoms during the two months of symptom diaries, then 40 subjects in each group will have 80% power (0.05) to detect a reduction to 42.2% (ie a 44% relative reduction) in the number of parents who develop cold symptoms. Comparison between groups will be made using Chi square tests for the primary outcome and ordinal or nominal distributed variables. Students t tests will be used for continuous variables, such as rhinoviral loads, after log transformation if they are not normally distributed. If they are not normalised by transformation then non parametric tests will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/04/2014
Actual
10/04/2014
Date of last participant enrolment
Anticipated
3/10/2014
Actual
9/06/2015
Date of last data collection
Anticipated
Actual
4/08/2015
Sample size
Target
80
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 5679 0
New Zealand
State/province [1] 5679 0
Wellington

Funding & Sponsors
Funding source category [1] 288435 0
University
Name [1] 288435 0
University of Otago Research Grant (UORG)
Country [1] 288435 0
New Zealand
Primary sponsor type
Individual
Name
Julian Crane
Address
23a Mein Street
Newtown
Wellington
North Island
New Zealand 6021
Country
New Zealand
Secondary sponsor category [1] 287145 0
None
Name [1] 287145 0
None
Address [1] 287145 0
None
Country [1] 287145 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290310 0
Health and Disability Ethics Committee (Central)
Ethics committee address [1] 290310 0
Ethics committee country [1] 290310 0
New Zealand
Date submitted for ethics approval [1] 290310 0
16/01/2014
Approval date [1] 290310 0
14/03/2014
Ethics approval number [1] 290310 0
14/SCOTT/6

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

Contacts
Principal investigator
Name 44982 0
Prof Julian Crane
Address 44982 0
Department of Medicine
University of Otago, Wellington
23a Mein Street
Newtown
Wellington 6021
Country 44982 0
New Zealand
Phone 44982 0
+6449185258
Fax 44982 0
Email 44982 0
[email protected]
Contact person for public queries
Name 44983 0
Julian Crane
Address 44983 0
Department of Medicine
University of Otago, Wellington
23a Mein Street
Newtown
Wellington 6021
Country 44983 0
New Zealand
Phone 44983 0
+6449185258
Fax 44983 0
Email 44983 0
[email protected]
Contact person for scientific queries
Name 44984 0
Julian Crane
Address 44984 0
Department of Medicine
University of Otago, Wellington
23a Mein Street
Newtown
Wellington 6021
Country 44984 0
New Zealand
Phone 44984 0
+6449185258
Fax 44984 0
Email 44984 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.