A Proof Of Concept Study to Investigate the Clinical, Histological And Molecular Predictors of Response to Oral and Intranasal Corticosteroid in Nasal Polyposis - Prednisolone Induction

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001474-12-GB

Enrollment

120

Registered

2005-02-14

Start date

2006-05-16

Completion date

Unknown

Last updated

2017-04-03

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

Conditions

Nasal Polyposis

Interventions

Trade Name: Generically Prescribed Prednisolone 25mg daily Example of licence holder - Product Name: Prednisolone Tablets BP Pharmaceutical Form: Tablet CAS Number: 50-24-8 Current Sponsor code: Predn

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or Female Participants 16-75, with bilateral nasal polyposis of grade 2-3. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients who have used oral or nasule steroids within the preceding 3 months. Pregnant or breastfeeding mothers, or those taking inadequate contraceptive measures.

Design outcomes

Primary

Measure	Time frame
Main Objective: Medical polypectomy involves use of steroids to induce regression of nasal polyps. We aim to determine the degree of benefit of commencing such treatment with 2 weeks of oral steroid.;Secondary Objective: Characterising and attempting to group polyposis sufferers into groups (by a variety of measures) in order to predict likely response to steroid treatment.;Primary end point(s): Changes in visually assessed score of polyp grading.	—

Measure

Time frame

Main Objective: Medical polypectomy involves use of steroids to induce regression of nasal polyps. We aim to determine the degree of benefit of commencing such treatment with 2 weeks of oral steroid.;Secondary Objective: Characterising and attempting to group polyposis sufferers into groups (by a variety of measures) in order to predict likely response to steroid treatment.;Primary end point(s): Changes in visually assessed score of polyp grading.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026