Medical Polypectomy and Predictors of Response - Full Text View

Purpose

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.

Condition	Intervention	Phase
Nasal Polyps	Drug: Prednisolone Drug: Placebo Other: fluticasone nasal drops Other: fluticasone nasal spray	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Proof Of Concept Study to Investigate the Clinical, Histological And Molecular Predictors of Response to Oral and Intranasal Corticosteroid in Nasal Polyposis

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate Fluticasone propionate Fluticasone

U.S. FDA Resources

Further study details as provided by University of Dundee:

Primary Outcome Measures:

Endoscopy Polyp Grading [ Time Frame: 0, 2 weeks, 10 weeks, 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mini RQLQ [ Time Frame: 0, 2 wks, 10 wks, 28 wks ] [ Designated as safety issue: No ]
TNS-4 [ Time Frame: 0, 2 wks, 10 wks, 28 wks ] [ Designated as safety issue: No ]
PNIF [ Time Frame: 0,2 wks, 10 wks,28 wks ] [ Designated as safety issue: No ]
Anosmia score [ Time Frame: 0, 2 wks, 10 wks, 28 wks ] [ Designated as safety issue: No ]
Scratch n Sniff cards [ Time Frame: 0, 2 wks, 10 wks, 28 wks ] [ Designated as safety issue: No ]
OUCC [ Time Frame: 0, 2 wks, 10 wks, 28 wks ] [ Designated as safety issue: Yes ]
1 mcg Synacthen test [ Time Frame: 0, 2 wks, 10 wks, 28 wks ] [ Designated as safety issue: Yes ]

Enrollment:	60
Study Start Date:	May 2004
Study Completion Date:	November 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo 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: Placebo tablets once daily Other: fluticasone nasal drops fluticasone nasal drops 800mcg/d Other: fluticasone nasal spray fluticasone nasal spray 400 mcg/d
Experimental: Prednisolone 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: Prednisolone tablets 25 mg/day Other: fluticasone nasal drops fluticasone nasal drops 800mcg/d Other: fluticasone nasal spray fluticasone nasal spray 400 mcg/d

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female
18-75 years of age
bilateral nasal polyposis Grade 2 and above
with or without asthma
with or without atopy or aspirin sensitivity
written informed consent

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788749

Locations

United Kingdom
Ninewells Hospital and Medical School
Dundee, Angus, United Kingdom, DD1 9SY

Sponsors and Collaborators

University of Dundee

Chief Scientist Office of the Scottish Government

NHS Tayside

Investigators

Principal Investigator:	Sriram Vaidyanathan, MRCS	University of Dundee
Study Director:	Brian J Lipworth, MD	University of Dundee

More Information

No publications provided by University of Dundee

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Jun 16.

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.

Responsible Party:	Sriram Vaidyanathan, University of Dundee
ClinicalTrials.gov Identifier:	NCT00788749 History of Changes
Other Study ID Numbers:	GRAY07
Study First Received:	November 7, 2008
Last Updated:	November 10, 2008
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Dundee:

chronic rhinosinusitis
nasal polyps
oral steroid
intranasal steroid
medical polypectomy

Additional relevant MeSH terms:

Nasal Polyps
Polyps
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Methylprednisolone acetate
Prednisolone acetate
Fluticasone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents

Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013