NCT03174483

Brief Summary

To detect the effect of hypertonic saline and fluticasone sprays on computed tomography scan of paranasal sinuses of patients having chronic sinusitis and/or nasal polyps.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 2, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 31, 2017

Last Update Submit

May 31, 2017

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (1)

  • The percentage of patient with normal radiological scoring

    the score used is Lund Mackay radiological scoring

    1 month

Study Arms (2)

hypertonic saline

EXPERIMENTAL

nasal spray will be used twice daily

Drug: Hypertonic saline

fluticasone

ACTIVE COMPARATOR

nasal spray will be used once daily

Drug: Fluticasone Nasal

Interventions

Hypertonic salineDRUG

nasal spray

hypertonic saline
Fluticasone NasalDRUG

nasal spray

fluticasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with chronic sinusitis and/or nasal polyps.

You may not qualify if:

  • Patients with previous nasal or sinus surgery.
  • Patients with sinonasal Malignancy.
  • Immunocompromised patients.
  • Patients with ciliary motility disorders.
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

Saline Solution, Hypertonic

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Hussein Weshahy, MD

CONTACT

00201001775898weshahy_orl@aun.edu.eg

Mohammad Osman, MD

CONTACT

00201005267182mohamedosman@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 2, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

June 2, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)