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Prednisone in Chronic Rhinosinusitis Without Nasal Polyps

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ClinicalTrials.gov Identifier: NCT02367118
Recruitment Status : Unknown
Verified June 2015 by Constanza J. Valdes, University of Chile.
Recruitment status was:  Recruiting
First Posted : February 20, 2015
Last Update Posted : June 4, 2015
Sponsor:
Collaborator:
Sociedad Chilena de Otorrinolaringología, Medicina y Cirugía de Cabeza y Cuello
Information provided by (Responsible Party):
Constanza J. Valdes, University of Chile

February 8, 2015
February 20, 2015
June 4, 2015
June 2015
March 2016   (Final data collection date for primary outcome measure)
  • Changes in Symptoms as measured by SNOT 22 questionnaire and visual analogue scale at 6 months [ Time Frame: Improvement in symptoms at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo ]
  • Change in Olfactory function as measured by "Sniffin'Sticks 12 tests" at 6 months [ Time Frame: Improvement in Olfactory function at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo ]
  • Change in Nasal patency as measured by Acoustic rhinometry and Rhinomanometry at 6 months [ Time Frame: Improvement in nasal patency at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo ]
  • Changes in Nasal endoscopy findings as measured by Lund-Kennedy score at 6 months [ Time Frame: Changes in nasal endoscopy findings at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo ]
  • Symptoms as measured by SNOT 22 questionnaire and visual analogue scale. [ Time Frame: Improvement in symptoms at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo ]
  • Olfactory function as measured by "Sniffin'Sticks 12 tests" [ Time Frame: Improvement in Olfactory function at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo ]
  • Nasal patency as measured by Acoustic rhinometry and Rhinomanometry [ Time Frame: Improvement in nasal patency at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo ]
  • Nasal endoscopy findings as measured by Lund-Kennedy score [ Time Frame: Changes in nasal endoscopy findings at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo ]
Complete list of historical versions of study NCT02367118 on ClinicalTrials.gov Archive Site
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Prednisone in Chronic Rhinosinusitis Without Nasal Polyps
Prednisone in Chronic Rhinosinusitis Without Nasal Polyps. A Double-blind, Randomized, Placebo-controlled Trial
The purpose of this study is to determine whether prednisone is effective in the treatment of chronic rhinosinusitis without nasal polyps in adult patients.

General Objective:

1. Compare clinical improvement in adult patients with chronic rhinosinusitis without nasal polyps (CRSsNP) through application of SNOT 22 questionnaire and visual analogue scale of symptoms, sniff test, acoustic rhinometry and rhinomanometry and nasal endoscopy using Lund-Kennedy score, after 6 months of follow-up after treatment prednisone or placebo plus standard medical treatment for 21 days.

Specific Objectives:

  1. Compare decreased in SNOT-22 questionnaire score and visual analog scale of symptoms after treatment with prednisone or placebo.
  2. Compare decreased in nasal endoscopy findings, through application of Lund-Kennedy score, after treatment with prednisone or placebo.
  3. Compare improvements in smell after treatment with prednisone or placebo.
  4. Determine whether there are differences in nasal permeability measured by rhinomanometry and acoustic rhinometry after treatment with prednisone or placebo.
  5. Determine whether there is a difference in the SNOT 22 questionnaire score, visual analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients and eosinophilia, and CRSsNP patients with normal eosinophils, receiving prednisone or placebo .
  6. Determine if there is a difference in the SNOT 22 questionnaire score, visual analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients with elevated total immunoglobulin E and CRSsNP patients with normal total immunoglobulin E, receiving treatment with prednisone or placebo.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Sinusitis
  • Chronic Rhinosinusitis
  • Drug: Prednisone
  • Drug: Placebo
  • Experimental: Prednisone
    Intervention: prednisone 5 mg tablets taken orally, in decreasing doses. Beginning with 6 tablets (30 mg) daily for 7 days, then 3 tablets (15 mg) daily for 7 days, then 1 tablet (5 mg) daily for 7 days. Total days of treatment: 21 days.
    Intervention: Drug: Prednisone
  • Placebo Comparator: Placebo
    Intervention: placebo tablets taken orally (similar to prednisone), in decreasing doses. Beginning with 6 tablets daily for 7 days, then 3 tablets daily for 7 days, then 1 tablet daily for 7 days. Total days of treatment: 21 days.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
90
Same as current
December 2016
March 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of CRSsNP as recommended European Position Paper on Rhinosinusitis and Nasal Polyps 2012

Exclusion Criteria:

  • Treatment with oral corticosteroids or topical corticosteroids the last 4 weeks.
  • Previous surgical treatment for CRSsNP
  • History of diabetes mellitus and / or glaucoma and / or decompensated hypertension and / or gastric ulcer.
  • Pregnancy.
  • History of cystic fibrosis, primary ciliary dyskinesia, immunodeficiency, allergic fungal sinusitis, nasal polyps, nasal tumors, hepatic or renal dysfunction.
  • Hypersensitivity to prednisone
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
 
NCT02367118
PRD- CRSsNP-1
No
Not Provided
Not Provided
Constanza J. Valdes, University of Chile
University of Chile
Sociedad Chilena de Otorrinolaringología, Medicina y Cirugía de Cabeza y Cuello
Study Director: Constanza J Valdes, MD University of Chile
Principal Investigator: Marcela A Veloz, MD University of Chile
University of Chile
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP