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Ciclesonide vs Fluticasone Nasal Sprays in Nasal Poplyposis

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ClinicalTrials.gov Identifier: NCT02665806
Recruitment Status : Unknown
Verified January 2016 by Mohsen Naraghi, Tehran University of Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Mohsen Naraghi, Tehran University of Medical Sciences

Brief Summary:
This study is designed to compare ciclesonide nasal spray once daily with fluticasone propionate aquas nasal spray BD, which is commonly prescribed in patients with nasal polyposis, in order to relieve symptoms of these patients.

Condition or disease Intervention/treatment Phase
Chronic Rhinosinustis With Polyps Drug: Ciclesonide Drug: Fluticasone Phase 3

Detailed Description:

The study will be conducted in a tertiary ENT center in Tehran. Endoscopic severity grades for patients will be determined for polyps on the basis of 3 point classification system: 1, confined to middle meatus; 2, below level of middle turbinate; 3, causing total obstruction. Also, patients will be undergone paranasal sinus CT scan to determine Lund-Mackay stage which defined by sum of scores of each of 12 paranasal sinuses (0 for a completely lucent, 1 for a partially opaque and 2 for a completely opaque sinus). Patients will be randomized to treat in one of two groups: 1 month of therapy with fluticasone propionate aqueous nasal spray (FPANS) 200 µg twice a day or 1 month of therapy with intranasal ciclesonide spray 200 µg once daily. All patients will be given written, easy to understand instruction about how to use nasal sprays. All included patients are asked to answer the disease specific Persian language validated SNOT20 quality of life questionnaire to evaluate symptom severity before starting the treatment. SNOT20 is a symptom severity and health related quality of life measure in sinonasal diseases that contains 20 questions about CRS related symptoms. Symptoms severity is scored 0, indicating no problem to 5, indicating worst possible symptom. Then scores of each of 20 items will be added to produce a total score ranging from 0 to 100. After one month of treatment patients will be visited by a blind physician to assess the symptoms. Then patients will answer the SNOT20 questionnaire again. Patients will be given a chance to report any problem during drug administration and enquired about adverse effects at the end of 1 month of treatment by the physician. Withdrawals is defined as any drug or study discontinuation due to adverse effects or lack of efficacy.

By considering 5% level of significance, to have 90% power to detect a clinically important difference of 0.6 points between two groups in improving total score of SNOT20 assuming a standard deviation (SD) of 0.6, we should include 22 cases in each study arm. To address a 10% probable loss to follow up, we would recruit 24 cases in each arm.

The continuous variables will be shown as mean ± SD. The categorical variables will be presented as frequency and percentage. The normality of measure outcome variables will be tested graphically as well as statistically with the Shapiro-Wilk test. In case of normal distribution we would use parametric t-test to compare the mean values between two groups. Otherwise we would use non-parametric Mann-Whitney test. Chi-squared or Fischer-exact tests will be used to compare categorical variables. All the statistical analyses will be conducted using IBM SPSS statistics for Windows, version 23.0, (Armonk, NY: IBM Corp.).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ciclesonide vs Fluticasone Propionate Nasal Sprays in Patients With Nasal Poplyposis; a Randomized Clinical Trial
Study Start Date : January 2016
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ciclesonide Drug: Ciclesonide
intranasal ciclesonide spray 200 µg once daily

Active Comparator: Fluticasone Drug: Fluticasone
fluticasone propionate aqueous nasal spray 200 µg twice a day




Primary Outcome Measures :
  1. SNOT20 score difference [ Time Frame: 1 Month ]
    The change from the baseline in SNOT20 total score after the treatment period


Secondary Outcome Measures :
  1. SNOT20 score difference in variuos endoscopic grades [ Time Frame: 1 Month ]
    The change from the baseline in SNOT20 total score after the treatment period in patients with various endoscopic grades

  2. SNOT20 score difference in variuos Lund-Mackay score [ Time Frame: 1 Month ]
    The change from the baseline in SNOT20 total score after the treatment period in patients with various paranasanl sinus CT Scan's Lund-Mackay scores



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with the diagnosis of symptomatic nasal polyposis included.
  • Objective confirmation of chronic rhinosinusitis with polyps was done by paranasal sinuses CT scan and Endoscopy.

Exclusion Criteria:

  • Administration of systemic corticosteroids during last 3 months Administration of antihistamines, nasal steroids 15 days prior the including to the study.
  • History of surgical treatment during last 3 month.
  • History of septal deviation, severe epistaxis, cystic fibrosis, severe or non-controlled asthma, current purulent nasal infection, allergic rhinitis.
  • Hypersensitivity or contraindication to steroids.
  • Any positive history that was suspected to influence study parameters.
  • NP requiring systemic corticosteroids or daily use of saline irrigations.

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): NCT02665806


Contacts
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Contact: Salar Tofighi, MD +989124109390 dr.salar.tofighi@gmail.com
Contact: Saeed Soleymanjahi, MD +989143919441 saeed.s.jahi@gmail.com

Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Mohsen Naraghi, MD Tehran University of Medical Sciences, Department of Otolaryngology-Head and Neck Surgery, Tehran, Iran
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Responsible Party: Mohsen Naraghi, Assistant Professor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02665806    
Other Study ID Numbers: IR.TUMS.REC.1394.1586
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mohsen Naraghi, Tehran University of Medical Sciences:
Ciclesonide
Fluticasone propionate
Nasal Polyposis
Chronic Sinuitis
Chronic rhinosinusitis
Additional relevant MeSH terms:
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Fluticasone
Ciclesonide
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