NCT04213508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

December 7, 2019

Last Update Submit

January 19, 2020

Conditions

Otorhinolaryngologic DiseasesRhinosinusitis

Outcome Measures

Primary Outcomes (2)

  • 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 from baseline of Sino-Nasal Outcome Test 22 (SNOT-22) at 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

    Change from baseline of Peri-Operative Sinus Endoscopy (POSE) at 1 month

Study Arms (4)

Isotonic saline with frequency of 2 times per day

ACTIVE COMPARATOR

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 .

Drug: Isotonic Saline ( 0.9% Sodium Chloride Saline)

Hypertonic saline with frequency of 2 times per day

ACTIVE COMPARATOR

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 .

Drug: Hypertonic Saline ( 3% Sodium Chloride Saline)

Isotonic saline with frequency of 5 times per day

ACTIVE COMPARATOR

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 .

Drug: Isotonic Saline ( 0.9% Sodium Chloride Saline)

Hypertonic saline with frequency of 5 times per day

ACTIVE COMPARATOR

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 .

Drug: Hypertonic Saline ( 3% Sodium Chloride Saline)

Interventions

Isotonic Saline ( 0.9% Sodium Chloride Saline)DRUG

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 .

Isotonic saline with frequency of 2 times per dayIsotonic saline with frequency of 5 times per day
Hypertonic Saline ( 3% Sodium Chloride Saline)DRUG

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 .

Hypertonic saline with frequency of 2 times per dayHypertonic saline with frequency of 5 times per day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam abdulrahman bin faisal university

Dammam, Eastern Province, 31952, Saudi Arabia

Location

MeSH Terms

Conditions

Otorhinolaryngologic DiseasesRhinosinusitis

Interventions

Sodium ChlorideSaline Solution, Hypertonic

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsHypertonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Mohammad H Albar, MD

    Imam Abdulrahman Bin Faisal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad H Albar, MD

CONTACT

00966506641110malbar@iau.edu.sa

Ahmed A Alrahim, MD

CONTACT

00966555805616dr.ahmed5616@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double Blind Study ( Both Participants and Investigator are masked ).
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2019

First Posted

December 30, 2019

Study Start

February 1, 2020

Primary Completion

January 1, 2021

Study Completion

December 31, 2021

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

SA(1)