Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001008819
Ethics application status
Not yet submitted
Date submitted
13/09/2012
Date registered
19/09/2012
Date last updated
19/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of Dry Powder Mannitol for the Treatment of Chronic Rhinosinusitis
Scientific title
Patients with chronic rhinosinusitis receiving intranasal mannitol powder, compared to standard medical therapies, to alleviate sinusitis symptoms.
Secondary ID [1] 281226 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis 287414 0
Condition category
Condition code
Respiratory 287748 287748 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 287791 287791 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dry mannitol powder (a natural product), delivered intranasally, along with standard medical care (listed below). Mannitol dosing:s 150 mg/puff, patients will be guided to use it as 3 nasal puffs in each nostril three times per day for 6 months
Intervention code [1] 285692 0
Treatment: Other
Comparator / control treatment
Standard medical treatment:
1) Avoidance of allergens
2) Normal saline nasal rinse
3) Steroid nasal spray
4) +/- A course of oral steroids
5) +/- A course of Antibiotics if required
6) CT scan to evaluate the paranasal sinuses and the presence of polyps
7) Regular follow-up that can range from every 6 weeks to once a year
8) +/- Surgery (Depends on the severity of the disease)
Control group
Active

Outcomes
Primary outcome [1] 287983 0
We will be looking at 3 different parameters:
1. symptom control as per the symptom questionnaire Sino-Nasal Outcome Test (SNOT)-22.
Timepoint [1] 287983 0
every 6 weeks for a period of 6 months
Secondary outcome [1] 299183 0
2. improvement in the status of the lining of the nose and paranasal sinus lining as per the examination standardized scoring system (Lund/Kennedy Score).
Timepoint [1] 299183 0
every 6 weeks for a period of 6 months
Secondary outcome [2] 299184 0
3. improvement in the scoring for the CT scan of the nose and paranasal sinuses before and after treatment (Lund/MacKay Score).
Timepoint [2] 299184 0
every 6 weeks for a period of 6 months

Eligibility
Key inclusion criteria
Patients with chronic rhinosinusitis (as defined by the Canadian clinical practice guidelines for acute and chronic sinusitis)
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous sinus surgery
Allergy or sensitivity to any of the items in the standard medical treatment

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)
Patients will be enrolled from the primary investigators clinic. If willing to volunteer they will have an identifier number generated by computer program to ensure anonymity. The identifier numbers will then be randomized by a third party using a random sequence generator. Concealment of allocation will be accomplished by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use block randomization. 40 patients will be recruited and allocated equally to each group (allocation ratio 1:1).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4558 0
Canada
State/province [1] 4558 0

Funding & Sponsors
Funding source category [1] 286004 0
Self funded/Unfunded
Name [1] 286004 0
Country [1] 286004 0
Canada
Primary sponsor type
Individual
Name
Dr Emad Massoud
Address
3rd Floor Dickson Building
QEII Health Science Centre/Dalhousie University
5820 University Avenue
Halifax, Nova Scotia
B3H 1V7
Country
Canada
Secondary sponsor category [1] 284822 0
None
Name [1] 284822 0
Address [1] 284822 0
Country [1] 284822 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288051 0
Capital District Health Authority Research Ethics Board
Ethics committee address [1] 288051 0
Capital Health Research Ethics Board
Centre for Clinical Research, Room 118
QEII Health Science Centre
5790 University Ave., Halifax NS
B3H 1V7
Ethics committee country [1] 288051 0
Canada
Date submitted for ethics approval [1] 288051 0
01/10/2012
Approval date [1] 288051 0
Ethics approval number [1] 288051 0

Summary
Brief summary
Chronic Rhinosinusitis is a chronic condition of the nose and paranasal sinuses. Patients suffering from chronic sinusitis complain of headaches, nasal congestion and thick nasal discharge. The burden of chronic sinusitis on our society is high. It causes increased cost to health care system and decreased productivity with loss of work days. No single treatment was found to control the symptoms of chronic sinusitis. It was found that dry mannitol delivered to the lungs of patients with cystic fibrosis makes the secretions less thick, easier to clear and symptoms better controlled. We believe these effects are transferrable to chronic sinusitis patients. We believe that mannitol will help loosen their nasal discharge, making it easier to clear and eventually control their symptoms better
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34708 0
Address 34708 0
Country 34708 0
Phone 34708 0
Fax 34708 0
Email 34708 0
Contact person for public queries
Name 17955 0
Blair Williams
Address 17955 0
ENT Clinic, 3rd Floor Dickson Building
QEII Health Science Centre/Dalhousie University
5820 University Avenue
Halifax, Nova Scotia
B3H 1V7
Country 17955 0
Canada
Phone 17955 0
+1-902-452-5336
Fax 17955 0
Email 17955 0
[email protected]
Contact person for scientific queries
Name 8883 0
Blair Williams
Address 8883 0
ENT Clinic, 3rd Floor Dickson Building
QEII Health Science Centre/Dalhousie University
5820 University Avenue
Halifax, Nova Scotia
B3H 1V7
Country 8883 0
Canada
Phone 8883 0
+1-902-452-5336
Fax 8883 0
Email 8883 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.