Chronic SinusitisNCT03174483
Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps
A study testing Hypertonic saline and Fluticasone Nasal in people with Chronic Sinusitis, run by Assiut University at 1 site in Egypt.
Trial summary
To detect the effect of hypertonic saline and fluticasone sprays on computed tomography scan of paranasal sinuses of patients having chronic sinusitis and/or nasal polyps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Hypertonic saline and Fluticasone Nasal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2017to Jul 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with chronic sinusitis and/or nasal polyps.
Who cannot join
- Patients with previous nasal or sinus surgery.
- Patients with sinonasal Malignancy.
- Immunocompromised patients.
- Patients with ciliary motility disorders.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut
Heba Abdel aal, MBBCh, 00201119125556, happydocotor777@gmail.com
About this study
Official title: Effects of Hypertonic Saline and Fluticasone Nasal Sprays on Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps
To detect the effect of hypertonic saline and fluticasone sprays on computed tomography scan of paranasal sinuses of patients having chronic sinusitis and/or nasal polyps.
- Conditions
- Chronic Sinusitis
- Being tested
- Hypertonic saline, Fluticasone Nasal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic salineDrug
nasal spray
Fluticasone NasalDrug
nasal spray
| Study group | Role | What they receive |
|---|---|---|
| hypertonic saline | Experimental | nasal spray will be used twice daily Receives: Drug: Hypertonic saline |
| fluticasone | Active comparator | nasal spray will be used once daily Receives: Drug: Fluticasone Nasal |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patient with normal radiological scoring
the score used is Lund Mackay radiological scoring
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study startJun 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Abdel aal Mekhamar Abdel aal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174483
- Sponsor's protocol ID
- HSCS
- Status last verified
- May 2017
- First submitted
- 31 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypertonic Saline and Fluticasone Nasal Sprays on Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps
- ClinicalTrials.gov ID
- NCT03174483
- Acronym / sponsor ID
- HSCS
- Conditions
- Chronic Sinusitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 2 Jun 2017 (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.
To detect the effect of hypertonic saline and fluticasone sprays on computed tomography scan of paranasal sinuses of patients having chronic sinusitis and/or nasal polyps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertonic saline | Experimental | Drug: Hypertonic salinenasal spray will be used twice daily |
| fluticasone | Active comparator | Drug: Fluticasone Nasalnasal spray will be used once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with chronic sinusitis and/or nasal polyps.
Key exclusion criteria (5 listed)
- Patients with previous nasal or sinus surgery.
- Patients with sinonasal Malignancy.
- Immunocompromised patients.
- Patients with ciliary motility disorders.
- Pregnant women
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 |
|---|---|---|
| Hypertonic salinenasal spray | Drug | hypertonic saline |
| Fluticasone Nasalnasal spray | Drug | fluticasone |
Primary outcome
The percentage of patient with normal radiological scoring
Time frame: 1 month
the score used is Lund Mackay radiological scoring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertonic saline and Fluticasone Nasal in people with Chronic Sinusitis, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 5 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 2 Jun 2017. 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 Egypt. 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.
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 Hussein Weshahy, MD (00201001775898, weshahy_orl@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patient with normal radiological scoring (time frame: 1 month). 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 2 Jun 2017.