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

NCT ID: NCT01478425

Last Updated: 2011-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-08-31

Brief 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.

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.

Conditions

Allergic Rhinitis

Keywords

Prevention; Pollen; Allergy; Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Active

Lipidic Microemulsion

Group Type: EXPERIMENTAL

Lipidic Microemulsion

Intervention Type: DEVICE

Topical nasal, twice a day

Control

Saline nose-spray device

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DEVICE

Topical Nasal, twice a day

Interventions

Lipidic Microemulsion

Topical nasal, twice a day

Intervention Type: DEVICE

Saline

Topical Nasal, twice a day

Intervention Type: DEVICE

Other Intervention Names

Blox4

Eligibility 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.

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.

Exclusion Criteria

1. Known asthma of any origin (intrinsic or extrinsic, the latter due to any kind of allergenic trigger).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reig Jofre Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro Ojeda, PhD, MD

Role: STUDY_DIRECTOR

Clínica Ojeda

Morgan Andersson, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Lund University Hospital

Julio Delgado, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Ana Navarro, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Area Hospitalaria de Valme

Javier Subiza, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Subiza

José María Olaguibel, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario de Navarra

Francisco Feo-Brito, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General de Ciudad Real

Juan Manuel Igea, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Clínica Alergoasma

Alicia Alonso, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Paracelso Clínica Médico Quirúrgica

Locations

Hospital General de Ciudad Real

Ciudad Real, Ciudad Real, Spain

Clinica Ojeda

Madrid, Madrid, Spain

Clinica Subiza

Madrid, Madrid, Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Clinica Alergoasma

Salamanca, Salamanca, Spain

Hospital Universitario Virgen de la Macarena

Seville, Sevilla, Spain

Area Hospitalaria de Valme

Seville, Sevilla, Spain

Paracelso Clínica Médico Quirúrgica

Valladolid, Valladolid, Spain

Lund University Hospital

Lund, , Sweden

Countries

Spain; Sweden

References

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.

Reference Type: DERIVED

PMID: 23981504 (View on PubMed)

Other Identifiers

RJ-NME-11-01

Identifier Type: -

Identifier Source: org_study_id