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Type and Frequency of Nasal Irrigation in Rhinosinusitis Patients

Primary Purpose

Otorhinolaryngologic Diseases, Rhinosinusitis

Status
Unknown status
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Isotonic Saline ( 0.9% Sodium Chloride Saline)
Hypertonic Saline ( 3% Sodium Chloride Saline)
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Otorhinolaryngologic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age from 18 years of either gender
  • Acute and chronic rhinosinusitis

Exclusion Criteria:

  • History of nasal or sinus surgery
  • Age less than 18 years of either gender
  • diagnosis other than rhinosinusitis

Sites / Locations

  • Imam abdulrahman bin faisal university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Isotonic saline with frequency of 2 times per day

Hypertonic saline with frequency of 2 times per day

Isotonic saline with frequency of 5 times per day

Hypertonic saline with frequency of 5 times per day

Arm Description

0.9% Sodium Chloride (NaCl) saline will be used as nasal irrigation for 2 times per day. Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 200 ml of 0.9% Sodium Chloride (NaCl) saline will be used daily for 1 month .

3% Sodium Chloride (NaCl) saline will be used as nasal irrigation for 2 times per day. Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 200 ml of 3% Sodium Chloride (NaCl) saline will be used daily for 1 month .

0.9% Sodium Chloride (NaCl) saline will be used as nasal irrigation for 5 times per day. Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 500 ml of 0.9% Sodium Chloride (NaCl) saline will be used daily for 1 month .

3% Sodium Chloride (NaCl) saline will be used as nasal irrigation for 5 times per day. Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 500 ml of 3% Sodium Chloride (NaCl) saline will be used daily for 1 month .

Outcomes

Primary Outcome Measures

Change in Sino-Nasal Outcome Test 22 .
The Sino-Nasal Outcome Test (SNOT-22) is a validated chronic rhinosinusitis -specific outcome measure consisting of 22 items that captures sinus-specific and general health-related impact of the disease process. To answer the instrument, patients suggest their level of affection in each domain and identify the most 5 important items. Each item quantifies symptoms severity from 0 (no problem) to 5 (worst symptom). The sum of each item results in a maximum score of 110 while the minimum is 0 . High score indicates poor outcome. Arabic version of a validated and reliable SNOT-22 will utilize in this study. We will measure the change of SNOT-22 from our baseline after follow up in 1 month
Change in Peri-Operative Sinus Endoscopy Score
Peri-Operative Sinus Endoscopy Score (POSE) is objective endoscopic scoring system was utilized to assess the surgical outcomes in the sinonasal cavities through the evaluation of the middle turbinate, middle meatal antrostomy,ethmoid cavity, and secondary sinuses.The sum of maxiumum score is 20 while the minimum is 0 . High score indicates poor result . Th We will measure the change of POSE from our baseline after follow up in 1 month

Secondary Outcome Measures

Full Information

First Posted
December 7, 2019
Last Updated
January 19, 2020
Sponsor
Imam Abdulrahman Bin Faisal University
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1. Study Identification

Unique Protocol Identification Number
NCT04213508
Brief Title
Type and Frequency of Nasal Irrigation in Rhinosinusitis Patients
Official Title
Isotonic vs Hypertonic Nasal Irrigation and Frequency of Irrigation Per Day in Rhinosinusitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imam Abdulrahman Bin Faisal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Rhinosinusitis is a common clinical problem with significant morbidity which alters patients' quality of life that has its effect on 1 out of 7 adults. It has been found that rhinosinusitis accounts for almost 26 million clinics and emergency visits per year in United states .Nasal irrigation is standard management used to treat a variety of sinonasal diseases. Furthermore, nasal irrigation decreases the need of usage other medications in rhinosinusitis .Hence, it is considered safe, inexpensive, and easy to use with no evidence of major adverse effects .Up to our knowledge, there is no clear guideline in which type (isotonic saline vs hypertonic saline) and frequency (times per day) of nasal irrigation are superior and better.
Detailed Description
Nasal irrigation is one of the main treatment of sinonasal diseases. The mechanism of action of nasal irrigation has many physiological aspects such as removing of excess mucus which is a potential medium for bacterial growth and infection, cleaning of antigens and biofilm to decrease inflammatory process, increase mucocilliary function and removing curst and debris from post-surgery to enhance wound healing and mucosalization Hypertonic saline is defined as a solution with more than 0.9% weight per volume of sodium chloride while isotonic saline is defined as a solution that equals to 0.9% weight per volume of sodium chloride. There are controversial studies in the literature on which saline is superior on the other, some prefer hypertonic saline over isotonic saline because it can move water outside the cells, decrease edema of mucosa, increase hydration of sol layer and decrease muco-adhesiveness and improve mucociliary clearance while others found both solution had same efficacy, improved nasal stuffiness and nasal obstruction but patients prefer isotonic saline because it is well tolerated and less burning sensation. Frequency of nasal irrigation per day is poorly studied in the literature with no known recommended times per day. Our aim is to find which type of saline and number of irrigation per day are better and statistically significant .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otorhinolaryngologic Diseases, Rhinosinusitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double Blind Study ( Both Participants and Investigator are masked ).
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isotonic saline with frequency of 2 times per day
Arm Type
Active Comparator
Arm Description
0.9% Sodium Chloride (NaCl) saline will be used as nasal irrigation for 2 times per day. Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 200 ml of 0.9% Sodium Chloride (NaCl) saline will be used daily for 1 month .
Arm Title
Hypertonic saline with frequency of 2 times per day
Arm Type
Active Comparator
Arm Description
3% Sodium Chloride (NaCl) saline will be used as nasal irrigation for 2 times per day. Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 200 ml of 3% Sodium Chloride (NaCl) saline will be used daily for 1 month .
Arm Title
Isotonic saline with frequency of 5 times per day
Arm Type
Active Comparator
Arm Description
0.9% Sodium Chloride (NaCl) saline will be used as nasal irrigation for 5 times per day. Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 500 ml of 0.9% Sodium Chloride (NaCl) saline will be used daily for 1 month .
Arm Title
Hypertonic saline with frequency of 5 times per day
Arm Type
Active Comparator
Arm Description
3% Sodium Chloride (NaCl) saline will be used as nasal irrigation for 5 times per day. Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 500 ml of 3% Sodium Chloride (NaCl) saline will be used daily for 1 month .
Intervention Type
Drug
Intervention Name(s)
Isotonic Saline ( 0.9% Sodium Chloride Saline)
Intervention Description
0.9% Sodium Chloride (NaCl) saline will be used as nasal irrigation for two groups. (first groups 2 times per day and second group 5 times per day ). Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 500 ml of 0.9% Sodium Chloride (NaCl) saline will be used daily for 1 month .
Intervention Type
Drug
Intervention Name(s)
Hypertonic Saline ( 3% Sodium Chloride Saline)
Intervention Description
3% Sodium Chloride (NaCl) saline will be used as nasal irrigation for two groups. (first groups 2 times per day and second group 5 times per day ). Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time). So, in total 200 ml of 3% Sodium Chloride (NaCl) saline will be used daily for 1 month .
Primary Outcome Measure Information:
Title
Change in Sino-Nasal Outcome Test 22 .
Description
The Sino-Nasal Outcome Test (SNOT-22) is a validated chronic rhinosinusitis -specific outcome measure consisting of 22 items that captures sinus-specific and general health-related impact of the disease process. To answer the instrument, patients suggest their level of affection in each domain and identify the most 5 important items. Each item quantifies symptoms severity from 0 (no problem) to 5 (worst symptom). The sum of each item results in a maximum score of 110 while the minimum is 0 . High score indicates poor outcome. Arabic version of a validated and reliable SNOT-22 will utilize in this study. We will measure the change of SNOT-22 from our baseline after follow up in 1 month
Time Frame
Change from baseline of Sino-Nasal Outcome Test 22 (SNOT-22) at 1 month
Title
Change in Peri-Operative Sinus Endoscopy Score
Description
Peri-Operative Sinus Endoscopy Score (POSE) is objective endoscopic scoring system was utilized to assess the surgical outcomes in the sinonasal cavities through the evaluation of the middle turbinate, middle meatal antrostomy,ethmoid cavity, and secondary sinuses.The sum of maxiumum score is 20 while the minimum is 0 . High score indicates poor result . Th We will measure the change of POSE from our baseline after follow up in 1 month
Time Frame
Change from baseline of Peri-Operative Sinus Endoscopy (POSE) at 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age from 18 years of either gender Acute and chronic rhinosinusitis Exclusion Criteria: History of nasal or sinus surgery Age less than 18 years of either gender diagnosis other than rhinosinusitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad H Albar, MD
Phone
00966506641110
Email
malbar@iau.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Alrahim, MD
Phone
00966555805616
Email
dr.ahmed5616@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad H Albar, MD
Organizational Affiliation
Imam Abdulrahman Bin Faisal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imam abdulrahman bin faisal university
City
Dammam
State/Province
Eastern Province
ZIP/Postal Code
31952
Country
Saudi Arabia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohammad h albar, md
Phone
00966506641110
Email
malbar@iau.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Type and Frequency of Nasal Irrigation in Rhinosinusitis Patients

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