NCT00788749

Brief Summary

This is the first randomized parallel group clinical trial looking at oral prednisolone induced medical nasal polypectomy followed by maintenance on topical steroid therapy in patients with nasal polyposis. This study also looks at the effect of aspirin sensitivity and the factors linking nasal polyps with asthma. We have also taken baseline measurements of a variety of blood, surface and biopsy markers to assess for potential to predict steroid response. Finally, the still unchartered link between nasal polyps and asthma will be explored by measuring Staphylococcal superantigens in serum before and after treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
Last Updated

November 11, 2008

Status Verified

November 1, 2008

Enrollment Period

3.8 years

First QC Date

November 7, 2008

Last Update Submit

November 10, 2008

Conditions

Nasal Polyps

Keywords

chronic rhinosinusitisnasal polypsoral steroidintranasal steroidmedical polypectomy

Outcome Measures

Primary Outcomes (1)

  • Endoscopy Polyp Grading

    0, 2 weeks, 10 weeks, 28 weeks

Secondary Outcomes (7)

  • Mini RQLQ

    0, 2 wks, 10 wks, 28 wks

  • TNS-4

    0, 2 wks, 10 wks, 28 wks

  • PNIF

    0,2 wks, 10 wks,28 wks

  • Anosmia score

    0, 2 wks, 10 wks, 28 wks

  • Scratch n Sniff cards

    0, 2 wks, 10 wks, 28 wks

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo tablets for 2 weeks followed by fluticasone nasal drops 800mcg/d for 2 months followed by fluticasone nasal spray 400 mcg/d for 4 months

Drug: PlaceboOther: fluticasone nasal dropsOther: fluticasone nasal spray

Prednisolone

EXPERIMENTAL

25 mg Prednisolone OD for 2 weeks followed by Fluticasone nasal drops 800 mcg/d for 2 months, followed by fluticasone nasal spray 400mcg/day for 4 months

Drug: PrednisoloneOther: fluticasone nasal dropsOther: fluticasone nasal spray

Interventions

PrednisoloneDRUG

tablets 25 mg/day

Prednisolone
PlaceboDRUG

tablets once daily

Placebo
fluticasone nasal dropsOTHER

fluticasone nasal drops 800mcg/d

PlaceboPrednisolone
fluticasone nasal sprayOTHER

fluticasone nasal spray 400 mcg/d

PlaceboPrednisolone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female
  • years of age
  • bilateral nasal polyposis Grade 2 and above
  • with or without asthma
  • with or without atopy or aspirin sensitivity
  • written informed consent

You may not qualify if:

  • unilateral nasal polyposis
  • polypoid lesion suspicious of inverted papilloma, malignancy, Wegeners granulomatosis, sarcoidosis
  • known or suspected hypersensitivity to fluticasone propionate or any other constituents of the Investigational Medicinal product (IMP).
  • Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
  • significant (≥50%)septal deviation
  • inability to comply with the requirements of the protocol
  • females who are pregnant, lactating or planning to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ninewells Hospital and Medical School

Dundee, Angus, DD1 9SY, United Kingdom

Location

Related Publications (2)

  • Williamson PA, Vaidyanathan S, Clearie K, Barnes M, Lipworth BJ. Airway dysfunction in nasal polyposis: a spectrum of asthmatic disease? Clin Exp Allergy. 2011 Oct;41(10):1379-85. doi: 10.1111/j.1365-2222.2011.03793.x. Epub 2011 Jun 16.

    PMID: 21676042DERIVED

  • Vaidyanathan S, Barnes M, Williamson P, Hopkinson P, Donnan PT, Lipworth B. Treatment of chronic rhinosinusitis with nasal polyposis with oral steroids followed by topical steroids: a randomized trial. Ann Intern Med. 2011 Mar 1;154(5):293-302. doi: 10.7326/0003-4819-154-5-201103010-00003.

    PMID: 21357906DERIVED

MeSH Terms

Conditions

Nasal Polyps

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Sriram Vaidyanathan, MRCS

    University of Dundee

    PRINCIPAL INVESTIGATOR

  • Brian J Lipworth, MD

    University of Dundee

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2008

First Posted

November 11, 2008

Study Start

May 1, 2004

Primary Completion

February 1, 2008

Study Completion

November 1, 2008

Last Updated

November 11, 2008

Record last verified: 2008-11

Locations

GB(1)