Budesonide Irrigation in Allergic Rhinitis
ConditionAllergic Rhinitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSiriraj Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 Participants would be withdrawn if severe complications arise from the use of topical budesonide.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 design
Design model
Parallel
Treatments tested in this trial
The budesonide nasal irrigation
DrugThe 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
DrugThe 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).
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: The budesonide nasal irrigation groupExperimental treatment 1 intervention
Group B: The budesonide nasal spray groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 1. Mild symptoms (present but not bothersome) 2. Moderate symptoms (noticeable and somewhat bothersome) 3. Severe symptoms (very bothersome and interfering with daily activities)
Time frame
Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.Secondary outcomes
1
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.
Time frame
Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.2
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.
Time frame
Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.3
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).
Time frame
Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.4
Adverse events
All adverse events occurred during the usage of budesonide nasal irrigation were reported.
Time frame
Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.Sponsors and contacts
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Source ClinicalTrials.gov
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