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Type and Frequency of Nasal Irrigation in Rhinosinusitis Patients

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ClinicalTrials.gov Identifier: NCT04213508
Recruitment Status : Not yet recruiting
First Posted : December 30, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Dammam University

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.

Condition or disease Intervention/treatment Phase
Otorhinolaryngologic Diseases Rhinosinusitis Drug: Isotonic Saline ( 0.9% Sodium Chloride Saline) Drug: Hypertonic Saline ( 3% Sodium Chloride Saline) Phase 4

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind Study ( Both Participants and Investigator are masked ).
Primary Purpose: Supportive Care
Official Title: Isotonic vs Hypertonic Nasal Irrigation and Frequency of Irrigation Per Day in Rhinosinusitis Patients
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Isotonic saline with frequency of 2 times per day
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)
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 .

Active Comparator: Hypertonic saline with frequency of 2 times per day
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)
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 .

Active Comparator: Isotonic saline with frequency of 5 times per day
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)
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 .

Active Comparator: Hypertonic saline with frequency of 5 times per day
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)
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 Measures :
  1. Change in Sino-Nasal Outcome Test 22 . [ Time Frame: Change from baseline of Sino-Nasal Outcome Test 22 (SNOT-22) at 1 month ]

    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


  2. Change in Peri-Operative Sinus Endoscopy Score [ Time Frame: Change from baseline of Peri-Operative Sinus Endoscopy (POSE) at 1 month ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213508


Contacts
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Contact: Mohammad H Albar, MD 00966506641110 malbar@iau.edu.sa
Contact: Ahmed A Alrahim, MD 00966555805616 dr.ahmed5616@gmail.com

Locations
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Saudi Arabia
Imam abdulrahman bin faisal university
Dammam, Eastern Province, Saudi Arabia, 31952
Contact: mohammad h albar, md    00966506641110    malbar@iau.edu.sa   
Sponsors and Collaborators
Dammam University
Investigators
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Principal Investigator: Mohammad H Albar, MD Imam Abdulrahman Bin Faisal University

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Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT04213508    
Other Study ID Numbers: IRB-2019-01-262
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Sinusitis
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections