NCT02665806

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

January 25, 2016

Last Update Submit

January 25, 2016

Conditions

Chronic Rhinosinustis With Polyps

Keywords

CiclesonideFluticasone propionateNasal PolyposisChronic SinuitisChronic rhinosinusitis

Outcome Measures

Primary Outcomes (1)

  • SNOT20 score difference

    The change from the baseline in SNOT20 total score after the treatment period

    1 Month

Secondary Outcomes (2)

  • SNOT20 score difference in variuos endoscopic grades

    1 Month

  • SNOT20 score difference in variuos Lund-Mackay score

    1 Month

Study Arms (2)

Ciclesonide

EXPERIMENTAL
Drug: Ciclesonide

Fluticasone

ACTIVE COMPARATOR
Drug: Fluticasone

Interventions

CiclesonideDRUG

intranasal ciclesonide spray 200 µg once daily

Ciclesonide
FluticasoneDRUG

fluticasone propionate aqueous nasal spray 200 µg twice a day

Fluticasone

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nasal Polyps

Interventions

ciclesonideFluticasone

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Mohsen Naraghi, MD

    Tehran University of Medical Sciences, Department of Otolaryngology-Head and Neck Surgery, Tehran, Iran

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salar Tofighi, MD

CONTACT

+989124109390dr.salar.tofighi@gmail.com

Saeed Soleymanjahi, MD

CONTACT

+989143919441saeed.s.jahi@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 25, 2016

First Posted

January 28, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share