Evaluation of Inhaled Treatment in Sinusitis

NCT ID: NCT01907204

Last Updated: 2014-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Oral

Oral drug (methylprednisolone) administration

Group Type ACTIVE_COMPARATOR

methylprednisolone

Intervention Type DRUG

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

Metered dose inhaler

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

Budesonide by metered dose inhaler

Nebulized

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

Budesonide by nebulization

Interventions

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methylprednisolone

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

Intervention Type DRUG

Budesonide

Budesonide by metered dose inhaler

Intervention Type DRUG

Budesonide

Budesonide by nebulization

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Nasal/Sinus polyps

Exclusion Criteria

* Previous sinus surgery
* Age under 18y
* Use of antibiotics
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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G.Reychler

Docteur Gregory Reychler

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory Reychler, PhD

Role: STUDY_DIRECTOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Philippe Rombaux, Prof PhD

Role: STUDY_DIRECTOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Coralie Colbrant, PT

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other Identifiers

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Sinusitis001

Identifier Type: -

Identifier Source: org_study_id

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