NCT01907204

Brief Summary

The purpose of this study is to determine whether inhaled corticosteroid (specially nebulized) could be a good alternative to oral corticosteroid and whether they are effective in the treatment of sinusitis

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_2

Status
completed

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

July 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 27, 2014

Status Verified

January 1, 2014

Enrollment Period

1 month

First QC Date

July 12, 2013

Last Update Submit

January 24, 2014

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (1)

  • Sniffin' Sticks Test

    Baseline and day 15

Secondary Outcomes (2)

  • Specific quality of life questionnaire (Snot 20)

    Baseline and day 15

  • Retro Olfaction Test

    Baseline and day 15

Study Arms (3)

Oral

ACTIVE COMPARATOR

Oral drug (methylprednisolone) administration

Drug: methylprednisolone

Metered dose inhaler

EXPERIMENTAL
Drug: Budesonide

Nebulized

EXPERIMENTAL
Drug: Budesonide

Interventions

methylprednisoloneDRUG

Oral 32mg/8d-16mg/4d-8mg/4d

Oral
BudesonideDRUG

Budesonide by metered dose inhaler

Metered dose inhaler

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nasal/Sinus polyps

You may not qualify if:

  • Previous sinus surgery
  • Age under 18y
  • Use of antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sinusitis

Interventions

MethylprednisoloneBudesonide

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnenedionesPregnenes

Study Officials

  • Gregory Reychler, PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    STUDY DIRECTOR

  • Philippe Rombaux, Prof PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    STUDY DIRECTOR

  • Coralie Colbrant, PT

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Docteur Gregory Reychler

Study Record Dates

First Submitted

July 12, 2013

First Posted

July 24, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2013

Study Completion

January 1, 2014

Last Updated

January 27, 2014

Record last verified: 2014-01