Medical Polypectomy and Predictors of Response - Full Text View

Sponsors and Collaborators:	University of Dundee Chief Scientist Office Scotland NHS Tayside
Information provided by:	University of Dundee
ClinicalTrials.gov Identifier:	NCT00788749

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 IV

MedlinePlus related topics: Asthma

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Corticosteroids Fluticasone Fluticasone propionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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: 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: Placebo tablets once daily Other: fluticasone nasal drops fluticasone nasal drops 800mcg/d Other: fluticasone nasal spray fluticasone nasal spray 400 mcg/d
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: 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, Angus
Ninewells Hospital and Medical School
Dundee, Angus, United Kingdom, DD1 9SY

Sponsors and Collaborators

University of Dundee

Chief Scientist Office Scotland

NHS Tayside

Investigators

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

More Information

Responsible Party:	University of Dundee ( Sriram Vaidyanathan )
Study ID Numbers:	GRAY07
Study First Received:	November 7, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00788749
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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Nasal Polyps
Otorhinolaryngologic Diseases
Methylprednisolone
Prednisolone

Methylprednisolone acetate
Fluticasone
Prednisolone acetate
Polyps
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Anti-Allergic Agents
Glucocorticoids

Hormones
Nose Diseases
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009