Otorhinolaryngologic DiseasesPhase 4NCT04213508
Type and Frequency of Nasal Irrigation in Rhinosinusitis Patients
A Phase 4 study testing Isotonic Saline ( 0.9% Sodium Chloride Saline) and Hypertonic Saline ( 3% Sodium Chloride Saline) in people with Otorhinolaryngologic Diseases and Rhinosinusitis, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Otorhinolaryngologic Diseases, Rhinosinusitis
- What is being tested?
- Isotonic Saline ( 0.9% Sodium Chloride Saline) and Hypertonic Saline ( 3% Sodium Chloride Saline)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2020to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 18 years of either gender
- Acute and chronic rhinosinusitis
Who cannot join
- History of nasal or sinus surgery
- Age less than 18 years of either gender
- diagnosis other than rhinosinusitis
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Imam abdulrahman bin faisal university
Dammam, Eastern Province, 31952
mohammad h albar, md, 00966506641110, malbar@iau.edu.sa
About this study
Official title: Isotonic vs Hypertonic Nasal Irrigation and Frequency of Irrigation Per Day in Rhinosinusitis Patients
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.
Read the 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 .
- Conditions
- Otorhinolaryngologic Diseases, Rhinosinusitis
- Being tested
- Isotonic Saline ( 0.9% Sodium Chloride Saline), Hypertonic Saline ( 3% Sodium Chloride Saline)
- Medical subject headings
- Otorhinolaryngologic Diseases, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 .
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 .
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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 . Receives: 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 . Receives: 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 . Receives: Drug: Hypertonic Saline ( 3% Sodium Chloride Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from baseline of Peri-Operative Sinus Endoscopy (POSE) at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start1 Feb 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otorhinolaryngologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad H Albar, MD, Principal investigator, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213508
- Sponsor's protocol ID
- IRB-2019-01-262
- Status last verified
- Jan 2020
- First submitted
- 7 Dec 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isotonic vs Hypertonic Nasal Irrigation and Frequency of Irrigation Per Day in Rhinosinusitis Patients
- ClinicalTrials.gov ID
- NCT04213508
- Acronym / sponsor ID
- IRB-2019-01-262
- Conditions
- Otorhinolaryngologic Diseases, Rhinosinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Isotonic saline with frequency of 2 times per day | Active comparator | Drug: Isotonic Saline ( 0.9% Sodium Chloride Saline)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 . |
| Hypertonic saline with frequency of 2 times per day | Active comparator | Drug: Hypertonic Saline ( 3% Sodium Chloride Saline)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 . |
| Isotonic saline with frequency of 5 times per day | Active comparator | Drug: Isotonic Saline ( 0.9% Sodium Chloride Saline)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 . |
| Hypertonic saline with frequency of 5 times per day | Active comparator | Drug: Hypertonic Saline ( 3% Sodium Chloride Saline)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 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age from 18 years of either gender
- Acute and chronic rhinosinusitis
Key exclusion criteria (3 listed)
- History of nasal or sinus surgery
- Age less than 18 years of either gender
- diagnosis other than rhinosinusitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 . | Drug | Isotonic saline with frequency of 2 times per day, Isotonic saline with frequency of 5 times per day |
| 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 . | Drug | Hypertonic saline with frequency of 2 times per day, Hypertonic saline with frequency of 5 times per day |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad H Albar, MD principal investigator
Imam Abdulrahman Bin Faisal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isotonic Saline ( 0.9% Sodium Chloride Saline) and Hypertonic Saline ( 3% Sodium Chloride Saline) in people with Otorhinolaryngologic Diseases and Rhinosinusitis, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad H Albar, MD (00966506641110, malbar@iau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sino-Nasal Outcome Test 22 . (time frame: Change from baseline of Sino-Nasal Outcome Test 22 (SNOT-22) at 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.