Nasal AllergyPhase 4NCT06858423
Budesonide Nasal Irrigation Versus Fluticasone Propionate Nasal Spray in Treating Allergic Rhinitis Patients
A Phase 4 study testing Budesonide buffered with 0.9% isotonic saline., Fluticasone propionate nasal spray. and 0.9% saline for nasal irrigation. in people with Nasal Allergy, run by Benha University at 1 site in Egypt.
Trial summary
Budesonide is a medication of the corticosteroid type. Available as an inhaler, nebulization solution, The inhaled form is used in the long-term management of asthma and chronic obstructive pulmonary disease is used for allergic rhinitis and nasal polyps fluticasone propionate Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nasal Allergy
- What is being tested?
- Budesonide buffered with 0.9% isotonic saline., Fluticasone propionate nasal spray. and 0.9% saline for nasal irrigation.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2023to 31 May 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult age between 18 and 60 years old.
- Patients with allergic rhinitis evidence by past skin prick testing. Patients were given a skin prick test with a panel of dog, cat, Dermatophagoides farinae, D pteronyssinus, Alternaria, Penicillium, Hormodendron, Aspergillus, grass pollen mix, tree pollen mix, and ragweed allergen extracts (100,000 Allergen Unit/mL). Histamine, 10 mg/mL, was used as a positive control, and the diluent was used as the negative control. A positive reaction was defined as a wheal diameter at least 3 mm greater than the diluent control and/or at least a 50-mm flare (ie, erythema measured as the sum of the greatest diameter and the perpendicular diameter through the midpoint of the greatest diameter)
Who cannot join
- Patients who had autoimmune diseases or any immune compromised diseases including diabetes, chemotherapy.
- Patients with a history of nasal surgery.
- Patients who received systemic or topical corticosteroids, herbal drugs, beta blocking agent within the previous month of enrolment.
- Patients with asthma and COPD, nasal bleeding, obstructing nasal polyps, paranasal sinus.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Benha University Hospitals - Otolaryngology department
Banhā, Qalyobia, 6460001
About this study
Official title: Budesonide Nasal Irrigation Versus Fluticasone Propionate Nasal Spray in the Treatment of Adult Patients With Allergic Rhinitis
Budesonide is a medication of the corticosteroid type. Available as an inhaler, nebulization solution, The inhaled form is used in the long-term management of asthma and chronic obstructive pulmonary disease is used for allergic rhinitis and nasal polyps fluticasone propionate
Read the detailed description
The current study aims to compare between results of budesonid nasal irrigation and fluticasone nasal spray in the treatment of adult patients with Allergic Rhinitis.
- Conditions
- Nasal Allergy
- Being tested
- Budesonide buffered with 0.9% isotonic saline., Fluticasone propionate nasal spray., 0.9% saline for nasal irrigation.
- Keywords
- allergic rhinitis, Budesonide, luticasone propionate
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide buffered with 0.9% isotonic saline.Drug
120 patients received budesonide buffered with 0.9% isotonic saline.
Fluticasone propionate nasal spray.Drug
120 patients received fluticasone propionate nasal spray.
0.9% saline for nasal irrigation.Other
120 patients used 0.9% saline for nasal irrigation.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Saline Group) | Placebo comparator | 120 patients used 0.9% saline for nasal irrigation. Receives: Other: 0.9% saline for nasal irrigation. |
| Group B (Fluticasone Propionate Nasal Spray) | Experimental | 120 patients received fluticasone propionate nasal spray. Receives: Drug: Fluticasone propionate nasal spray. |
| Group C (Budesonide Nasal Irrigation) | Experimental | 120 patients received budesonide buffered with 0.9% isotonic saline. Receives: Drug: Budesonide buffered with 0.9% isotonic saline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
improvement measured by pre- and post-treatment SNOT score
Measured: 1 month
Secondary outcomes (1)
Endoscopic examination improvement
by comparing pre and post treatment lund*Mackay score
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 posted5 Mar 2025
- Study start15 Aug 2023
- Primary completion31 Mar 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal AllergyStudies of the same condition, open and under way.
- More trials run by Benha 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Farid Abu Shady ,MD, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858423
- Sponsor's protocol ID
- MS-8-8-2023
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Budesonide Nasal Irrigation Versus Fluticasone Propionate Nasal Spray in the Treatment of Adult Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT06858423
- Acronym / sponsor ID
- MS-8-8-2023
- Conditions
- Nasal Allergy
- Keywords
- allergic rhinitis, Budesonide, luticasone propionate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 5 Mar 2025 (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.
Budesonide is a medication of the corticosteroid type. Available as an inhaler, nebulization solution, The inhaled form is used in the long-term management of asthma and chronic obstructive pulmonary disease is used for allergic rhinitis and nasal polyps fluticasone propionate
Detailed description
The current study aims to compare between results of budesonid nasal irrigation and fluticasone nasal spray in the treatment of adult patients with Allergic Rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Saline Group) | Placebo comparator | Other: 0.9% saline for nasal irrigation.120 patients used 0.9% saline for nasal irrigation. |
| Group B (Fluticasone Propionate Nasal Spray) | Experimental | Drug: Fluticasone propionate nasal spray.120 patients received fluticasone propionate nasal spray. |
| Group C (Budesonide Nasal Irrigation) | Experimental | Drug: Budesonide buffered with 0.9% isotonic saline.120 patients received budesonide buffered with 0.9% isotonic saline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult age between 18 and 60 years old.
- Patients with allergic rhinitis evidence by past skin prick testing. Patients were given a skin prick test with a panel of dog, cat, Dermatophagoides farinae, D pteronyssinus, Alternaria, Penicillium, Hormodendron, Aspergillus, grass pollen mix, tree pollen mix, and ragweed allergen extracts (100,000 Allergen Unit/mL). Histamine, 10 mg/mL, was used as a positive control, and the diluent was used as the negative control. A positive reaction was defined as a wheal diameter at least 3 mm greater than the diluent control and/or at least a 50-mm flare (ie, erythema measured as the sum of the greatest diameter and the perpendicular diameter through the midpoint of the greatest diameter)
Key exclusion criteria (4 listed)
- Patients who had autoimmune diseases or any immune compromised diseases including diabetes, chemotherapy.
- Patients with a history of nasal surgery.
- Patients who received systemic or topical corticosteroids, herbal drugs, beta blocking agent within the previous month of enrolment.
- Patients with asthma and COPD, nasal bleeding, obstructing nasal polyps, paranasal sinus.
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 |
|---|---|---|
| Budesonide buffered with 0.9% isotonic saline.120 patients received budesonide buffered with 0.9% isotonic saline. | Drug | Group C (Budesonide Nasal Irrigation) |
| Fluticasone propionate nasal spray.120 patients received fluticasone propionate nasal spray. | Drug | Group B (Fluticasone Propionate Nasal Spray) |
| 0.9% saline for nasal irrigation.120 patients used 0.9% saline for nasal irrigation. | Other | Group A (Saline Group) |
Primary outcome
Clinical improvement
Time frame: 1 month
improvement measured by pre- and post-treatment SNOT score
1 secondary outcome
Endoscopic examination improvement
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Budesonide buffered with 0.9% isotonic saline., Fluticasone propionate nasal spray. and 0.9% saline for nasal irrigation. in people with Nasal Allergy, run by Benha 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 5 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (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 5 Mar 2025.