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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reig Jofre Group
ClinicalTrials.gov Identifier:
NCT01478425
First received: November 21, 2011
Last updated: November 28, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
 Device: Lipidic Microemulsion
Device: Saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Further study details as provided by Reig Jofre Group:

Primary Outcome Measures:
  • global score of the mini-RQLQ at visit 2 (adjusting for the baseline value) [ Designated as safety issue: No ]
    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:
  • • Mini-RQLQ dimensions scores at visit 2 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    Same analysis applied to the primary outcome but to sums of symptomatic treatments at visits 2 and 3 instead of global score


Enrollment: 110
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Lipidic Microemulsion
 Device: Lipidic Microemulsion
Topical nasal, twice a day
Other Name: Blox4
Placebo Comparator: Control
Saline nose-spray device
 Device: Saline
Topical Nasal, twice a day

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478425

Locations
Spain
Complejo Hospitalario de Navarra
Pamplona, Navarra, Spain, 31008
Hospital General de Ciudad Real
Ciudad Real, Spain, 13005
Clinica Ojeda
Madrid, Spain, 28006
Clinica Subiza
Madrid, Spain, 28006
Clinica Alergoasma
Salamanca, Spain, 37001
Area Hospitalaria de Valme
Sevilla, Spain, 41014
Hospital Universitario Virgen de la Macarena
Sevilla, Spain, 41009
Paracelso Clínica Médico Quirúrgica
Valladolid, Spain, 47004
Sweden
Lund University Hospital
Lund, Sweden, 221 85
Sponsors and Collaborators
Reig Jofre Group
Investigators
Study Director: Pedro Ojeda, PhD, MD Clínica Ojeda
Principal Investigator: Morgan Andersson, PhD, MD Lund University Hospital
Principal Investigator: Julio Delgado, PhD, MD Hospital Universitario Virgen de la Macarena
Principal Investigator: Ana Navarro, PhD, MD Area Hospitalaria de Valme
Principal Investigator: Javier Subiza, PhD, MD Clinica 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 Clínica Alergoasma
Principal Investigator: Alicia Alonso, PhD, MD Paracelso Clínica Médico Quirúrgica
  More Information

No publications provided

Responsible Party: Reig Jofre Group
ClinicalTrials.gov Identifier: NCT01478425     History of Changes
Other Study ID Numbers: RJ-NME-11-01
Study First Received: November 21, 2011
Last Updated: November 28, 2011
Health Authority: Spain: CLEC Area Hospitalaria de Valme, Sevilla
Spain: CLEC Hospital Universitario Virgen de la Macarena, Sevilla
Spain: CEIC Hospital Universitario de La Princesa, Madrid
Spain: CEIC Gobierno de Navarra
Spain: CEIC Hospital Clínico Universitario de Valladolid
Spain: CEIC Hospital General de Ciudad Real
Sweeden: Lund Ethics Committee

Keywords provided by Reig Jofre Group:
Prevention
Pollen
Allergy
Rhinitis

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013