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Medical Polypectomy and Predictors of Response

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788749
First Posted: November 11, 2008
Last Update Posted: November 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Chief Scientist Office of the Scottish Government
NHS Tayside
Information provided by:
University of Dundee
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Endoscopy Polyp Grading [ Time Frame: 0, 2 weeks, 10 weeks, 28 weeks ]

Secondary Outcome Measures:
  • Mini RQLQ [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
  • TNS-4 [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
  • PNIF [ Time Frame: 0,2 wks, 10 wks,28 wks ]
  • Anosmia score [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
  • Scratch n Sniff cards [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
  • OUCC [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
  • 1 mcg Synacthen test [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sriram Vaidyanathan, University of Dundee
ClinicalTrials.gov Identifier: NCT00788749     History of Changes
Other Study ID Numbers: GRAY07
First Submitted: November 7, 2008
First Posted: November 11, 2008
Last Update Posted: November 11, 2008
Last Verified: November 2008

Keywords provided by University of Dundee:
chronic rhinosinusitis
nasal polyps
oral steroid
intranasal steroid
medical polypectomy

Additional relevant MeSH terms:
Nasal Polyps
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Prednisolone acetate
Methylprednisolone acetate
Fluticasone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Gastrointestinal Agents