Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000686202
Ethics application status
Approved
Date submitted
3/08/2009
Date registered
11/08/2009
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
Date results information initially provided
11/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Common Treatments for Common Colds: A Pilot Study
Scientific title
In patients with symptoms of the common cold or acute rhinosinusitus, does nasal saline spray, compared to usual care, decrease the duration of general unwellness.
Secondary ID [1] 303426 0
nil known
Universal Trial Number (UTN)
Trial acronym
Squirting Nasal saline Or Routine Treatment Study (SNORT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Common cold and acute rhinosinusitus 243447 0
Condition category
Condition code
Respiratory 239746 239746 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nasal saline spray administered at least 4 times per day in addition to usual care (excluding other nasal decongestants) until resolution of symptoms (considered the first day they are no longer troublesome and participants answer "yes" to the question "Are you well again?") or for 6 weeks, whichever comes first.
Intervention code [1] 237065 0
Treatment: Drugs
Comparator / control treatment
Usual care only (excluding other nasal decongestants). Usual care is likely to consist of a combination of common treatments available to relieve symptoms of common cold. These include, but are not limited to, cough lozenges, cough syrup, antibiotics, analgesics, honey and lemon, salt water gargling, rest, intake of fluids etc. Participants will be asked to indicate on their patient diary the treatments they have used each day until resolution of symptoms or for 6 weeks, whichever comes first.
Control group
Active

Outcomes
Primary outcome [1] 240502 0
Number of days until the return of wellness, indicated by the patient's assessment of the first day of wellbeing. Patients will be asked to fill in a patient diary at the end of each day to indicate the severity of their symptoms that day and answer the question "Are you well again?".
Timepoint [1] 240502 0
Days to resolution of symptoms or 6 weeks from day of enrolment in the study, whichever comes first.
Secondary outcome [1] 257056 0
Severity and duration of troublesome nasal stuffiness or rhinorrhea, cough, or malaise. This will be assessed via patient self-report on the severity of symptoms each day on a 4 point scale (0=Normal/not present, 1=Slight problem, 2=Moderate, 3=Severe).
Timepoint [1] 257056 0
Days to resolution or 6 weeks from day of enrolment in the study, whichever comes first.
Secondary outcome [2] 257057 0
antibiotic use - participants will indicate each day on their patient diary whether they took antibiotics that day.
Timepoint [2] 257057 0
Days to resolution or 6 weeks from day of enrolment in the study, whichever comes first.
Secondary outcome [3] 257058 0
acceptabilty and feasibility of study processes to patients, general practitioners and practice nurses. Patient satisfaction with their involvement in the study and, for the nasal saline group, use of the study medication, will be assessed at the time of the final follow-up phone call by asking for patient feedback. GPs and practice staff will similarly be asked to indicate satisfaction with their participation in the study in a telephone or face-to-face conversation.
Timepoint [3] 257058 0
study end

Eligibility
Key inclusion criteria
patients >= 2 years of age presenting to a participating General Practitioner (GP) with common cold with symptoms of runny nose, sore throat, sneezing, cough, lethargy etc, or acute rhinosinusitus. For inclusion, participants must have had symptoms for =5 days and =3 weeks.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will not be eligible if they have known or suspected Chronic Obstructive Pulmonary Disease (COPD); have been, or wish to use steam inhalations; have anatomical abnormalities or physical impairment preventing compliance with study protocol; have cognitive impairment preventing informed consent; or are known to the GP as having other social or medical issues that preclude involvement in this study. Any patient who, subsequent to the recruitment consultation, receives a positive identification of pertussis infection (Whooping Cough) will be excluded from the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2009
Actual
4/01/2010
Date of last participant enrolment
Anticipated
Actual
15/06/2012
Date of last data collection
Anticipated
Actual
30/06/2012
Sample size
Target
60
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 237440 0
Government body
Name [1] 237440 0
Primary Health Care Research, Evaluation and Development funding to the Discipline of General Practice.
Country [1] 237440 0
Australia
Primary sponsor type
University
Name
Dr Deborah Askew
Address
Discipline of General Practice
School of Medicine
University of Queensland
Herston Qld 4006
Country
Australia
Secondary sponsor category [1] 236929 0
None
Name [1] 236929 0
Address [1] 236929 0
Country [1] 236929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239567 0
The University of Queensland - Medical Research Committee
Ethics committee address [1] 239567 0
The University of Queensland
St. Lucia
4072 Queensland
Australia
Ethics committee country [1] 239567 0
Australia
Date submitted for ethics approval [1] 239567 0
10/07/2009
Approval date [1] 239567 0
05/08/2009
Ethics approval number [1] 239567 0
2009001246

Summary
Brief summary
The primary purpose of this study is to evaluate the effectiveness of adding nasal saline spray to usual care in reducing the symptoms of the common cold and acute rhinosinusitis. It is expected that using nasal saline spray will reduce the severity and duration of symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30005 0
Dr David King
Address 30005 0
Primary Care Clinical Unit
Level 8, Health Science building
Faculty of Medicine
The University of Queensland
Herston Qld 4029
Australia
Country 30005 0
Australia
Phone 30005 0
+61 7 336 55449
Fax 30005 0
Email 30005 0
[email protected]
Contact person for public queries
Name 13252 0
Deborah Askew
Address 13252 0
Primary Care clinical unit
Level 8, Health Science building
Faculty of Medicine
Royal Brisbane and Womens Hospital
Herston Qld 4029
Australia
Country 13252 0
Australia
Phone 13252 0
+61 7 3365 5449
Fax 13252 0
Email 13252 0
[email protected]
Contact person for scientific queries
Name 4180 0
Deb Askew
Address 4180 0
Primary Care clinical unit
Level 8, Health Science building
Faculty of Medicine
Royal Brisbane and Womens Hospital
Herston Qld 4029
Australia
Country 4180 0
Australia
Phone 4180 0
+61 7 3365 5449
Fax 4180 0
Email 4180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
information lost


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10602Study protocol    308326-(Uploaded-12-07-2019-15-51-22)-Study-related document.pdf
10603Informed consent form    308326-(Uploaded-12-07-2019-15-53-51)-Study-related document.doc
10604Analytic code    308326-(Uploaded-12-07-2019-15-56-22)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.