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A randomized, double-blind, double dummy study comparing polyp size reduction of corticosteroid nasal irrigations with nasal sprays in chronic rhinosinusitis with nasal polyp

Corticosteroid nasal irrigations in nasal polyp: A Double-blinded Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210604009
Enrollment
98
Registered
2021-06-04
Start date
2021-06-14
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Nasal polyp patient need effective topical corticosteroid method for control disease. corticosteroid nasal irrigations, nasal sprays, nasal polyp

Interventions

Budesonide respule (0.5mg/2mL) 1 mL + 0.9%NSS 100 ML BID Nasal spray
0.9%NSS nasal spray 2 puff BID,Nasal irrigation
0.9%NSS 100 ML BID Nasal spray
Budesonide nasal spray (64mcg/spray) 2 puff BID
Active Comparator Drug,Placebo Comparator Drug
Corticosteroid nasal irrigations ,0.9%NSS nasal irrigation

Sponsors

Faculty of Medicine, Prince of Songkla University,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Bilateral nasal polyp patient

Exclusion criteria

Exclusion criteria: 1. Previous sinus surgery. 2. Used systemic corticosteroid before 2 weeks, Nasal steroid before 4 weeks, Nasal decongestant before 1 day. 3. Bacterial /Viral/ Fungal rhinosinusitis patient. 4.Patient with systemic conditions Ex. immunodeficiency, autoimmune diseases, cystic fibrosis, mucociliary disorders 5. Patient with pulmonary tuberculosis, DM (uncontrol; Random plasma glucose>200 mg/dL). 6. Patient with severe deviated nasal septum. 7. Patient with steroid allergy, glaucoma.

Design outcomes

Primary

MeasureTime frame
Nasal polyp size within one month after end of the intervention Nasal polyp grading(0-3)

Secondary

MeasureTime frame
Nasal symptom score within one month after end of the intervention Patient reported outcome using a questionnaire interview

Countries

Thailand

Contacts

Public ContactChakapan Promsopa

Faculty of Medicine, Prince of Songkla University

arrm012@gmail.com0815990645

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026