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

Study on the Efficacy and Tolerability of a Topical Microemulsion in Patients With Intermittent or Persistent Allergic Rhinitis Due to Sensitization to Birch, Olive Tree or Grass Pollen

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Device: Lipidic Microemulsion; Device: Saline

Detailed Description

Main study investigator:

Dr. Pedro Ojeda Clínica de Asma y Alergia doctores Ojeda C/ Oquendo, 23 28006 Madrid, Spain T1.: +34 91 562 32 62 T2.: +34 91 562 67 27 F.: +34 91 562 53 96 e-mail: drojeda@telefonica.net

Objectives

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.

Study design:

Randomized, controlled, double-blind, parallel, multicentre multinational clinical trial, to show superiority of an active therapy as compared to a control therapy.

Study disease:

Intermittent or persistent Allergic Rhinitis.

Data from the drugs/interventions to be studied:

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.

Study population and total number of subjects:

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.

In order to participate in the study, eligible candidates must fulfill all the following inclusion criteria and none of the exclusion criteria:

Inclusion criteria

1. Patients of either gender, aged 18 years or older.
2. With previous diagnostic of allergic rhinitis or rhinoconjunctivitis due to sensitization to birch, grass or olive tree pollens. Patients sensitized to other inhaled allergens might be included provided that these other sensitizations are not relevant to the patient's clinical symptoms or they are not exposed to these other allergens.
3. Having suffered from allergic rhinitis symptoms (severe enough to require symptomatic medication usually prescribed for this condition) in previous years, but otherwise free of symptoms at inclusion.
4. Residing during the months from March to July of 2011 in a geographical area in which the exposure to birch, grass or olive tree pollens is relevant (average pollination peaks of 100 grains/m3 of air during the previous specific pollen season).
5. Providing written informed consent to participate in the study.

Exclusion criteria

1. Known asthma of any origin (intrinsic or extrinsic, the latter due to any kind of allergenic trigger).
2. Allergic rhinitis or rhinoconjunctivitis whose symptoms are exclusively due to the sensitization to other inhaled allergens different from those referred in the inclusion criteria, sensitization to pollens that may interfere with the patient's allergic status during the study period (e.g., plane tree pollen).
3. Rhinitis or rhinoconjunctivitis of allergic characteristics presenting in the spring season but with negative allergy study (skin prick tests (SPT)).
4. Asymptomatic sensitization to birch, grass or olive tree pollens.
5. Sensitization to birch, grass or olive tree pollens, but having had mild symptoms during the spring of 2010, not requiring the use of symptomatic medication.
6. Sensitization to birch, grass or olive tree pollens but only presenting with asthma symptoms.
7. Concurrent participation in another clinical trial at the time of this study.
8. Co-morbid conditions that, in the investigator's judgment, preclude them from participating in this study.
9. Continuous treatment with antihistamines, corticosteroids, immunosuppressants or any other drug that may alter the occurrence and/or severity of allergic symptoms.
10. Individuals that, even if they meet the inclusion criteria, are concurrently under treatment with allergen-specific immunotherapy or have received this treatment within the last 36 months.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Ciudad Real, Spain, 13005
    • Hospital General de Ciudad Real
  • Madrid, Spain, 28006
    • Clinica Ojeda
  • Madrid, Spain, 28006
    • Clínica Subiza
  • Salamanca, Spain, 37001
    • Clinica Alergoasma
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen De La Macarena
  • Sevilla, Spain, 41014
    • Area Hospitalaria de Valme
  • Valladolid, Spain, 47004
    • Paracelso Clínica Médico Quirúrgica
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Complejo Hospitalario de Navarra
• Sweden
  • Lund, Sweden, 221 85
    • Lund University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients of either gender, aged 18 years or older.
2. With previous diagnostic of allergic rhinitis or rhinoconjunctivitis due to sensitization to birch, grass or olive tree pollens. Patients sensitized to other inhaled allergens might be included provided that these other sensitizations are not relevant to the patient's clinical symptoms or they are not exposed to these other allergens.
3. Having suffered from allergic rhinitis symptoms (severe enough to require symptomatic medication usually prescribed for this condition) in previous years, but otherwise free of symptoms at inclusion.
4. Residing during the months from March to July of 2011 in a geographical area in which the exposure to birch, grass or olive tree pollens is relevant (average pollination peaks of 100 grains/m3 of air during the previous specific pollen season).
5. Providing written informed consent to participate in the study.

Exclusion Criteria:

1. Known asthma of any origin (intrinsic or extrinsic, the latter due to any kind of allergenic trigger).
2. Allergic rhinitis or rhinoconjunctivitis whose symptoms are exclusively due to the sensitization to other inhaled allergens different from those referred in the inclusion criteria, sensitization to pollens that may interfere with the patient's allergic status during the study period (e.g., plane tree pollen).
3. Rhinitis or rhinoconjunctivitis of allergic characteristics presenting in the spring season but with negative allergy study (skin prick tests (SPT)).
4. Asymptomatic sensitization to birch, grass or olive tree pollens.
5. Sensitization to birch, grass or olive tree pollens, but having had mild symptoms during the spring of 2010, not requiring the use of symptomatic medication.
6. Sensitization to birch, grass or olive tree pollens but only presenting with asthma symptoms.
7. Concurrent participation in another clinical trial at the time of this study.
8. Co-morbid conditions that, in the investigator's judgment, preclude them from participating in this study.
9. Continuous treatment with antihistamines, corticosteroids, immunosuppressants or any other drug that may alter the occurrence and/or severity of allergic symptoms.
10. Individuals that, even if they meet the inclusion criteria, are concurrently under treatment with allergen-specific immunotherapy or have received this treatment within the last 36 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; Lipidic Microemulsion	Device: Lipidic Microemulsion; Topical nasal, twice a day; Other Names: Blox4
Placebo Comparator: Control; Saline nose-spray device	Device: Saline; Topical Nasal, twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

global score of the mini-RQLQ at visit 2 (adjusting for the baseline value)

The primary analysis will be conducted on the global score of the mini-RQLQ at visit 2 (adjusting for the baseline value). It will be conducted on all randomized patients and will be considered as confirmatory. When visit 2 assessments are lacking, then no change from baseline will be assumed and baseline values will be carried forward to visit 2. As Normality and homcedasticity may be assumed, the analysis will consist of an ANCOVA model with a fixed treatment effect and baseline values as covariates.

Secondary Outcome Measures

Outcome Measure	Measure Description
• Mini-RQLQ dimensions scores at visit 2	Same analysis applied to the primary outcome but to individual dimensions of the RQLQ instead of global score
Mini-RQLQ global and dimensions scores at visit 3	Same analysis applied to the primary outcome but to individual dimensions of the RQLQ instead of global score
Mean of the sums of nasal symptom scores at visits 2 and 3	Same analysis applied to the primary outcome but to sums of nasal symptom scores at visits 2 and 3 instead of global score
Mean of the sums of ocular symptom scores at visits 2 and 3	Same analysis applied to the primary outcome but to sums of ocular symptom scores at visits 2 and 3 instead of global score
Mean of the sums of symptomatic treatments at visits 2 and 3	Same analysis applied to the primary outcome but to sums of symptomatic treatments at visits 2 and 3 instead of global score

Collaborators and Investigators

• Sponsor: Reig Jofre Group
• Investigators: Study Director: Pedro Ojeda, PhD, MD, Clinica Ojeda; Principal Investigator: Morgan Andersson, PhD, MD, Lund University Hospital; Principal Investigator: Julio Delgado, PhD, MD, Hospital Universitario Virgen Macarena; Principal Investigator: Ana Navarro, PhD, MD, Area Hospitalaria de Valme; Principal Investigator: Javier Subiza, PhD, MD, Clínica Subiza; Principal Investigator: José María Olaguibel, PhD, MD, Complejo Hospitalario de Navarra; Principal Investigator: Francisco Feo-Brito, PhD, MD, Hospital General de Ciudad Real; Principal Investigator: Juan Manuel Igea, PhD, MD, Clinica Alergoasma; Principal Investigator: Alicia Alonso, PhD, MD, Paracelso Clínica Médico Quirúrgica

Publications and helpful links

General Publications

• Ojeda P, Pique N, Alonso A, Delgado J, Feo F, Igea JM, Navarro A, Olaguibel JM, Subiza J, Nieto C, Andersson M. A topical microemulsion for the prevention of allergic rhinitis symptoms: results of a randomized, controlled, double-blind, parallel group, multicentre, multinational clinical trial (Nares study). Allergy Asthma Clin Immunol. 2013 Aug 27;9(1):32. doi: 10.1186/1710-1492-9-32.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: November 21, 2011
• First Submitted That Met QC Criteria: November 22, 2011
• First Posted (Estimate): November 23, 2011

Study Record Updates

• Last Update Posted (Estimate): November 29, 2011
• Last Update Submitted That Met QC Criteria: November 28, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Allergy; Prevention; Rhinitis; Pollen
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: RJ-NME-11-01