Does rinsing the nose with Budesonide before surgery help people with Nasal Polyps?

Pre-operative Nasal Irrigation with Budesonid in patients with Chronic Rhinosinusitis and Nasal Polyps: random clinical trial, double-blind and placebo controlled

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-10m3j8dw

Enrollment

Registered

2026-05-26

Start date

2022-03-29

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic sinusitis

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. A total of 52 individuals who meet the eligibility criteria will be randomly assigned to either a control group or an interventio

Eligibility

Inclusion criteria

Inclusion criteria: Volunteers diagnosed with chronic rhinosinusitis with nasal polyps; both genders; ages between 18 and 60 years

Exclusion criteria

Exclusion criteria: previous sinus surgery; current use of immunosuppressive therapy; use of antibiotics within the four weeks prior to enrollment; or sinonasal disease associated with systemic conditions such as immunodeficiency; Churg–Strauss vasculitis; granulomatosis with polyangiitis; autoimmune diseases or connective tissue disorders; patients with anatomical abnormalities that could prevent effective nasal irrigation (caudal septal deviation, choanal atresia, or complete nasal cavity obstruction by polyps); history of ocular herpes; pregnancy or breastfeeding; known hypersensitivity to budesonide; glaucoma; use of systemic or intranasal corticosteroids within the two weeks prior to inclusion (or unwillingness to discontinue such medications); patients unable or unwilling to provide informed consent or comply with study procedures were not eligible

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: the primary outcome was the change in the Sinonasal Outcome Test 22 (SNOT-22) from baseline to four weeks. The SNOT-22 is a validated 22-item questionnaire that assesses sinonasal symptoms, with scores ranging from 0 to 110 (higher scores indicating greater severity), and a minimal clinically important difference (MCID) of 14 points. It was expected that the mean difference between the placebo group and the intervention group would be greater than the MCID, 14 points;Observed outcome 1: the analysis of the 22-item Sinonasal Outcome Test at four weeks showed that the intervention group (budesonide nasal irrigation) had a mean difference of 18.1 points (95% CI: 3.4 to 32.8; p = 0.017) compared with the placebo group	—

Measure

Time frame

Expected outcome 1: the primary outcome was the change in the Sinonasal Outcome Test 22 (SNOT-22) from baseline to four weeks. The SNOT-22 is a validated 22-item questionnaire that assesses sinonasal symptoms, with scores ranging from 0 to 110 (higher scores indicating greater severity), and a minimal clinically important difference (MCID) of 14 points. It was expected that the mean difference between the placebo group and the intervention group would be greater than the MCID, 14 points;Observed outcome 1: the analysis of the 22-item Sinonasal Outcome Test at four weeks showed that the intervention group (budesonide nasal irrigation) had a mean difference of 18.1 points (95% CI: 3.4 to 32.8; p = 0.017) compared with the placebo group

—

Secondary

Measure	Time frame
Expected outcome 2: as a secondary outcome, we used subjective evaluation through a visual analog scale (VAS) from baseline to four weeks after the intervention. The visual analog scale ranged from 0 to 10 cm for nasal obstruction, rhinorrhea, facial pain/pressure, and hyposmia, with a minimal clinically important difference (MCID) of 1 point; higher scores indicate greater severity. It was expected that the mean difference between the placebo group and the intervention group would be greater than the MCID, 1 point;Observed outcome 2: the analysis of the visual analog scale after four weeks of intervention demonstrated a mean difference of 2.24 points (95% CI: 3.6 to 4.13; p = 0.020) between the placebo and intervention groups;Expected outcome 3: as a secondary outcome, we assessed the change in nasal endoscopy findings from baseline to four weeks after the intervention. For this evaluation, we used the Nasal Polyp Score (NPS), which ranges from 0 to 4 per nostril (0–8 total). Videos were recorded and centrally reviewed in a blinded manner by two independent rhinologists. A minimal clinically important difference (MCID) of 1 point was considered clinically significant. It was expected that the mean difference between the placebo group and the intervention group would be greater than the MCID, 1 point;Observed outcome 3: the analysis of the Nasal Polyp Score (NPS) after four weeks of intervention demonstrated a mean difference of 0.73 points (95% CI: 0.25 to 1.21; p = 0.003) between the placebo and intervention groups;Expected outcome 4: as a secondary outcome, we used the Connecticut Chemosensory Clinical Research Center (CCCRC) olfactory test, validated for Brazilian Portuguese, with scores ranging from 0 to 7; scores =6 were considered normal, and a minimal clinically important difference (MCID) of 1 point was used. It was expected that the mean difference between the placebo group and the intervention group would be greater than the MCID, 1 point;Observed outcome	—

Measure

Time frame

Expected outcome 2: as a secondary outcome, we used subjective evaluation through a visual analog scale (VAS) from baseline to four weeks after the intervention. The visual analog scale ranged from 0 to 10 cm for nasal obstruction, rhinorrhea, facial pain/pressure, and hyposmia, with a minimal clinically important difference (MCID) of 1 point; higher scores indicate greater severity. It was expected that the mean difference between the placebo group and the intervention group would be greater than the MCID, 1 point;Observed outcome 2: the analysis of the visual analog scale after four weeks of intervention demonstrated a mean difference of 2.24 points (95% CI: 3.6 to 4.13; p = 0.020) between the placebo and intervention groups;Expected outcome 3: as a secondary outcome, we assessed the change in nasal endoscopy findings from baseline to four weeks after the intervention. For this evaluation, we used the Nasal Polyp Score (NPS), which ranges from 0 to 4 per nostril (0–8 total). Videos were recorded and centrally reviewed in a blinded manner by two independent rhinologists. A minimal clinically important difference (MCID) of 1 point was considered clinically significant. It was expected that the mean difference between the placebo group and the intervention group would be greater than the MCID, 1 point;Observed outcome 3: the analysis of the Nasal Polyp Score (NPS) after four weeks of intervention demonstrated a mean difference of 0.73 points (95% CI: 0.25 to 1.21; p = 0.003) between the placebo and intervention groups;Expected outcome 4: as a secondary outcome, we used the Connecticut Chemosensory Clinical Research Center (CCCRC) olfactory test, validated for Brazilian Portuguese, with scores ranging from 0 to 7; scores =6 were considered normal, and a minimal clinically important difference (MCID) of 1 point was used. It was expected that the mean difference between the placebo group and the intervention group would be greater than the MCID, 1 point;Observed outcome

—

Countries

Contacts

Public ContactMarcel Miyake

Irmandade da Santa Casa de Misericórdia de São Paulo

marcel.miyake@gmail.com+55-11-941496928

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 11, 2026