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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

Brief Summary:
The purpose of this study is to determine whether prednisone is effective in the treatment of chronic rhinosinusitis without nasal polyps in adult patients.

Condition or disease Intervention/treatment Phase
Sinusitis Chronic Rhinosinusitis Drug: Prednisone Drug: Placebo Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prednisone in Chronic Rhinosinusitis Without Nasal Polyps. A Double-blind, Randomized, Placebo-controlled Trial
Study Start Date : June 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone
U.S. FDA Resources

Arm Intervention/treatment
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.
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.
Drug: Placebo



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02367118


Contacts
Contact: Constanza J Valdes, MD 56-02-2575-3968 cjvaldes@gmail.com
Contact: Marcela A Veloz, MD 56-02-2575-3968 marceveloz@gmail.com

Locations
Chile
Hospital del Salvador Recruiting
Santiago, Region Metropolitana, Chile, 7600490
Contact: Constanza J Valdes, MD    56-02-2575-3968    cjvaldes@gmail.com   
Contact: Marcela A Veloz, MD    56-02-2575-3968    marceveloz@gmail.com   
Sub-Investigator: Nicole S Jimenez         
Sub-Investigator: Felipe Cardemil, MD         
Sponsors and Collaborators
University of Chile
Sociedad Chilena de Otorrinolaringología, Medicina y Cirugía de Cabeza y Cuello
Investigators
Study Director: Constanza J Valdes, MD University of Chile
Principal Investigator: Marcela A Veloz, MD University of Chile

Publications of Results:

Other Publications:

Responsible Party: Constanza J. Valdes, MD, Professor Assistant University of Chile. Department of Otorhinolaryngology-Head and Neck Surgery., University of Chile
ClinicalTrials.gov Identifier: NCT02367118     History of Changes
Other Study ID Numbers: PRD- CRSsNP-1
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by Constanza J. Valdes, University of Chile:
chronic rhinosinusitis without nasal polyps prednisone

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents