Allergic RhinitisPhase 4NCT06785662
Budesonide Irrigation in Allergic Rhinitis
A Phase 4 study testing The budesonide nasal irrigation and The budesonide nasal spray in people with Allergic Rhinitis, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
Topical nasal steroids are significant therapeutic options for allergic rhinitis (AR). The distribution of intranasal steroid spray (INS) administration is less than that of irrigation. However, the available data on steroid nasal irrigation is limited. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- The budesonide nasal irrigation and The budesonide nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteThailand
- Study dates
- 12 Feb 2025to 1 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Participants aged 18-60 years diagnosed with perennial allergic rhinitis based on ARIA guidelines, who have previously consistently used intranasal corticosteroids for at least 2 weeks with inadequate control of nasal inflammation defined by a VAS score of ≥5 out of 10 and requiring dosage adjustment. Noted that proper technique should have been confirmed through retrospective questioning.
Who cannot join
- Those with a history of sinus surgery, nasal or sinus tumors (including polyps), significant deviated nasal septum causing symptoms, oral corticosteroid uses for any indication, immunodeficiency, pregnancy, breastfeeding, or suspected fungal sinusitis indicated by ischemic nasal tissue, fungal masses, bone erosion, or calcifications on imaging were excluded. Participants would be withdrawn if severe complications arise from the use of topical budesonide.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Siriraj Hospital, Mahidol University
Bangkok, 10700
Navarat Kasemsuk, 0870890444, mintkus32@hotmail.com
Pomgsakorn Tantilipikorn, M.D., PhD., +66818363074, pongsakorn.tan@mahidol.ac.th
About this study
Official title: The Efficacy of Budesonide Nasal Irrigation in Allergic Rhinitis Patients: A Randomized, Controlled Trial.
Topical nasal steroids are significant therapeutic options for allergic rhinitis (AR). The distribution of intranasal steroid spray (INS) administration is less than that of irrigation. However, the available data on steroid nasal irrigation is limited. This article aims to evaluate the efficacy and adverse effects (AEs) of steroid irrigation in AR patients.
Read the detailed description
Allergic rhinitis is a prevalent health problem found in Thai population, with various treatment approaches available, such as avoiding triggering allergens, using pharmacological treatments, receiving allergy immunotherapy, and going on a surgery.[1] Nowadays, the use of topical medications, particularly steroids, plays a crucial role in treating nasal and sinus conditions due to their anti-inflammatory properties. Normally, steroids can be administered through diverse methods including nasal sprays, drops, and irrigation. The general guidelines for treating allergic rhinitis or chronic sinusitis typically emphasized the use of topical nasal steroids, particularly in spray form.[2, 3] Other forms of drug administration are generally considered alternative options. However, studies have shown that the distribution of medication via nasal spray is inferior to that of other delivery methods, including nasal irrigation. Most of the medication is concentrated in the anterior portion of the nasal cavity, particularly the nasal vestibule, with limited distribution to the inferior turbinate, superior turbinate, sphenoethmoidal recess, and superior olfactory cleft, compared to nasal irrigation. Therefore, the administration of topical steroids by nasal irrigation may serve as an alternative topical steroid delivery method.[4] Previous studies have mentioned the use of steroid nasal irrigation, primarily in patients with post-endoscopic sinus surgery for chronic sinusitis.[5-17] Additionally, there have been studies addressing its application in conditions such as allergic fungal rhinitis, acute sinusitis in children, and post-operative patients following septoplasty.[18, 19] The use of steroid nasal irrigation for treating allergic rhinitis has been scarcely discussed, and there is limited data available. One study investigated the use of budesonide nasal irrigation compared to normal saline nasal irrigation in patients with allergic rhinitis. The results showed that the Sinonasal Outcome Test-22 (SNOT-22) score and Visual Analog Scale (VAS) scores in the budesonide nasal irrigation group were significantly superior than those in the saline irrigation group.[20] However, there have been no studies conducted on patients with allergic rhinitis where nasal spray treatment was insufficient to control the symptoms of nasal inflammation. Additionally, no comparative studies between different drug administration techniques have been carried out.
This study aims to evaluate the efficacy of budesonide nasal irrigation in patients with allergic rhinitis, where the use of nasal steroid spray alone was insufficient to control nasal inflammation and required dosage adjustment. We hypothesized that administering steroids via nasal irrigation would improve drug distribution, leading to better outcomes.
- Conditions
- Allergic Rhinitis
- Being tested
- The budesonide nasal irrigation, The budesonide nasal spray
- Keywords
- intranasal corticosteroid, budesonide nasal irrigation, Budesonide nasal spray, Allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The budesonide nasal irrigationDrug
The participant in this group used a solution containing 1 milligram of budesonide mixed with 240 milliliters of normal saline in a squeeze bottle (Cleanoze®) for nasal irrigation. The procedure will be performed once daily while leaning slightly forward over a sink.
The budesonide nasal sprayDrug
The participants in this group used a nasal spray containing 64 micrograms of budesonide per spray, with two sprays per nostril administered twice daily (morning and evening).
| Study group | Role | What they receive |
|---|---|---|
| The budesonide nasal irrigation group | Experimental | The participant in this group used a solution containing 1 milligram of budesonide mixed with 240 milliliters of normal saline in a squeeze bottle (Cleanoze®) for nasal irrigation. The procedure will be performed once daily while leaning slightly forward over a sink. Receives: Drug: The budesonide nasal irrigation |
| The budesonide nasal spray group | Active comparator | The participant in this group used a nasal spray containing 64 micrograms of budesonide per spray, with two sprays per nostril administered twice daily (morning and evening). Receives: Drug: The budesonide nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS)
Full Name: Total Nasal Symptom Score Scale Range: 0 to 12 Scoring Interpretation: Higher scores indicate a worse outcome
Each symptom is rated by the participant on a scale (0 to 3), based on severity:
0: No symptoms
- Mild symptoms (present but not bothersome)
- Moderate symptoms (noticeable and somewhat bothersome)
- Severe symptoms (very bothersome and interfering with daily activities)
Measured: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Secondary outcomes (4)
Postnasal Drip Symptom Score (PND)
Postnasal Drip Symptom Score (PND) determines the severity of post nasal drip sensation
Full Name: Postnasal Drip Symptom Score Scale Range: 0 to 3 Scoring Interpretation: Higher scores indicate a worse outcome. The PND focuses specifically on the severity of postnasal drip symptoms, with scores representing none (0), mild (1), moderate (2), or severe (3) symptoms.
Measured: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Rhinoconjunctivitis Quality of Life Questionnaire (RCQ-36)
Rhinoconjunctivitis Quality of Life Questionnaire (RCQ-36) determine disease-specific quality of life
Full Name: Rhinoconjunctivitis Quality of Life Questionnaire - 36 Items Scale Range: 0 to 6 for each item, summing up to a total score. Scoring Interpretation: Higher scores indicate a worse outcome. This questionnaire assesses the impact of rhinoconjunctivitis symptoms on quality of life, covering domains such as sleep, activities, emotional well-being, and social functioning.
Measured: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Peak Nasal Inspiratory Flow (PNIF)
Peak Nasal Inspiratory Flow (PNIF) is an objective measurement to determine nasal patency
Full Name: Peak Nasal Inspiratory Flow Scale Range: Measured in liters per minute (L/min); there is no fixed maximum value, as it depends on individual physiology.
Scoring Interpretation: Higher values indicate a better outcome. PNIF measures the maximum airflow through the nasal passages during inspiration and is used as an objective measure of nasal patency (openness).
Measured: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Adverse events
All adverse events occurred during the usage of budesonide nasal irrigation were reported.
Measured: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start12 Feb 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial will be reported according to CONSORT 2010 statement for randomized controlled trials. The enrolled participants were assigned a study code that was enclosed in a sealed envelope, prepared by personnel not involved in the research, and then randomly allocated into one of two groups using a computer-generated random permuted blocks design. The outcomes assessors were blinded to the randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navarat Kasemsuk, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785662
- Sponsor's protocol ID
- Si044/2022
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Budesonide Nasal Irrigation in Allergic Rhinitis Patients: A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT06785662
- Acronym / sponsor ID
- Si044/2022
- Conditions
- Allergic Rhinitis
- Keywords
- intranasal corticosteroid, budesonide nasal irrigation, Budesonide nasal spray, Allergic rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 12 Feb 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 21 Jan 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.
Topical nasal steroids are significant therapeutic options for allergic rhinitis (AR). The distribution of intranasal steroid spray (INS) administration is less than that of irrigation. However, the available data on steroid nasal irrigation is limited. This article aims to evaluate the efficacy and adverse effects (AEs) of steroid irrigation in AR patients.
Detailed description
Allergic rhinitis is a prevalent health problem found in Thai population, with various treatment approaches available, such as avoiding triggering allergens, using pharmacological treatments, receiving allergy immunotherapy, and going on a surgery.[1] Nowadays, the use of topical medications, particularly steroids, plays a crucial role in treating nasal and sinus conditions due to their anti-inflammatory properties. Normally, steroids can be administered through diverse methods including nasal sprays, drops, and irrigation. The general guidelines for treating allergic rhinitis or chronic sinusitis typically emphasized the use of topical nasal steroids, particularly in spray form.[2, 3] Other forms of drug administration are generally considered alternative options. However, studies have shown that the distribution of medication via nasal spray is inferior to that of other delivery methods, including nasal irrigation. Most of the medication is concentrated in the anterior portion of the nasal cavity, particularly the nasal vestibule, with limited distribution to the inferior turbinate, superior turbinate, sphenoethmoidal recess, and superior olfactory cleft, compared to nasal irrigation. Therefore, the administration of topical steroids by nasal irrigation may serve as an alternative topical steroid delivery method.[4] Previous studies have mentioned the use of steroid nasal irrigation, primarily in patients with post-endoscopic sinus surgery for chronic sinusitis.[5-17] Additionally, there have been studies addressing its application in conditions such as allergic fungal rhinitis, acute sinusitis in children, and post-operative patients following septoplasty.[18, 19] The use of steroid nasal irrigation for treating allergic rhinitis has been scarcely discussed, and there is limited data available. One study investigated the use of budesonide nasal irrigation compared to normal saline nasal irrigation in patients with allergic rhinitis. The results showed that the Sinonasal Outcome Test-22 (SNOT-22) score and Visual Analog Scale (VAS) scores in the budesonide nasal irrigation group were significantly superior than those in the saline irrigation group.[20] However, there have been no studies conducted on patients with allergic rhinitis where nasal spray treatment was insufficient to control the symptoms of nasal inflammation. Additionally, no comparative studies between different drug administration techniques have been carried out.
This study aims to evaluate the efficacy of budesonide nasal irrigation in patients with allergic rhinitis, where the use of nasal steroid spray alone was insufficient to control nasal inflammation and required dosage adjustment. We hypothesized that administering steroids via nasal irrigation would improve drug distribution, leading to better outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This trial will be reported according to CONSORT 2010 statement for randomized controlled trials. The enrolled participants were assigned a study code that was enclosed in a sealed envelope, prepared by personnel not involved in the research, and then randomly allocated into one of two groups using a computer-generated random permuted blocks design. The outcomes assessors were blinded to the randomization.
| Arm | Type | Receives |
|---|---|---|
| The budesonide nasal irrigation group | Experimental | Drug: The budesonide nasal irrigationThe participant in this group used a solution containing 1 milligram of budesonide mixed with 240 milliliters of normal saline in a squeeze bottle (Cleanoze®) for nasal irrigation. The procedure will be performed once daily while leaning slightly forward over a sink. |
| The budesonide nasal spray group | Active comparator | Drug: The budesonide nasal sprayThe participant in this group used a nasal spray containing 64 micrograms of budesonide per spray, with two sprays per nostril administered twice daily (morning and evening). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants aged 18-60 years diagnosed with perennial allergic rhinitis based on ARIA guidelines, who have previously consistently used intranasal corticosteroids for at least 2 weeks with inadequate control of nasal inflammation defined by a VAS score of ≥5 out of 10 and requiring dosage adjustment. Noted that proper technique should have been confirmed through retrospective questioning.
Key exclusion criteria (1 listed)
- Those with a history of sinus surgery, nasal or sinus tumors (including polyps), significant deviated nasal septum causing symptoms, oral corticosteroid uses for any indication, immunodeficiency, pregnancy, breastfeeding, or suspected fungal sinusitis indicated by ischemic nasal tissue, fungal masses, bone erosion, or calcifications on imaging were excluded. Participants would be withdrawn if severe complications arise from the use of topical budesonide.
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 |
|---|---|---|
| The budesonide nasal irrigationThe participant in this group used a solution containing 1 milligram of budesonide mixed with 240 milliliters of normal saline in a squeeze bottle (Cleanoze®) for nasal irrigation. The procedure will be performed once daily while leaning slightly forward over a sink. | Drug | The budesonide nasal irrigation group |
| The budesonide nasal sprayThe participants in this group used a nasal spray containing 64 micrograms of budesonide per spray, with two sprays per nostril administered twice daily (morning and evening). | Drug | The budesonide nasal spray group |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Full Name: Total Nasal Symptom Score Scale Range: 0 to 12 Scoring Interpretation: Higher scores indicate a worse outcome Each symptom is rated by the participant on a scale (0 to 3), based on severity: 0: No symptoms 1. Mild symptoms (present but not bothersome) 2. Moderate symptoms (noticeable and somewhat bothersome) 3. Severe symptoms (very bothersome and interfering with daily activities)
4 secondary outcomes
Postnasal Drip Symptom Score (PND)
Time frame: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Rhinoconjunctivitis Quality of Life Questionnaire (RCQ-36)
Time frame: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Peak Nasal Inspiratory Flow (PNIF)
Time frame: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Adverse events
Time frame: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 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.
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 The budesonide nasal irrigation and The budesonide nasal spray in people with Allergic Rhinitis, run by Siriraj Hospital at 1 site in Thailand.
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 1 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: opening soon, as of the sponsor's last update on 21 Jan 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Navarat Kasemsuk, M.D. (+66870890444, mintkus32@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Nasal Symptom Score (TNSS) (time frame: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.). 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 21 Jan 2025.