Efficacy and Tolerability of a Topical Microemulsion in Patients With Allergic Rhinitis Due to Sensitization to Pollen

Summary

Study design: Randomized, controlled, double-blind, parallel, multicentre multinational clinical trial, to show superiority of an active therapy as compared to a control therapy on intermittent or persistent Allergic Rhinitis.

Primary objective:

1. To show that a topical microemulsion is superior to a sterilized saline solution to prevent deterioration in the health related quality of life, in patients with intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree or grass pollen.

Secondary objectives
2. To explore the effect of a topical microemulsion, as compared to a sterilized saline solution, for the prevention of nasal and ocular symptoms in patients with intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree or grass pollen.
3. To explore the effect of a topical microemulsion, as compared to a sterilized saline solution, in the utilization of symptomatic medications, in patients with intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree or grass pollen.
4. To assess the patient's satisfaction with a topical microemulsion treatment, as compared to a sterilized saline solution, in patients with intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree or grass pollen.
5. To assess the safety of a topical microemulsion, as compared to a sterilized saline solution, administered to patients with intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree or grass pollen.

This is a clinical investigation study of a Class 1 medical device product. This is a prospective study of an active medical device versus a control medical device.

It was considered feasible to recruit 10 patients patients per center, and therefore the study should be conducted in 10 centers. To get treatment balance within each center, a total of 100 patients should be recruited.

Conditions

• Allergic Rhinitis

Interventions

DEVICE

Lipidic Microemulsion

Topical nasal, twice a day

DEVICE

Saline

Topical Nasal, twice a day

Sponsors & Collaborators

• Reig Jofre Group

  lead INDUSTRY

Principal Investigators

• Pedro Ojeda, PhD, MD · Clínica Ojeda

• Morgan Andersson, PhD, MD · Lund University Hospital

• Julio Delgado, PhD, MD · Hospital Universitario Virgen Macarena

• Ana Navarro, PhD, MD · Area Hospitalaria de Valme

• Javier Subiza, PhD, MD · Clinica Subiza

• José María Olaguibel, PhD, MD · Complejo Hospitalario de Navarra

• Francisco Feo-Brito, PhD, MD · Hospital General de Ciudad Real

• Juan Manuel Igea, PhD, MD · Clínica Alergoasma

• Alicia Alonso, PhD, MD · Paracelso Clínica Médico Quirúrgica

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2011-06-30

Completion

2011-08-31

Countries

• Spain
• Sweden

Study Locations