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

NCT01478425 | Completed Phase 4 DMC

• 1 other identifier: RJ-NME-11-01
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 9

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. 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.
2. 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. 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. 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. 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.

Conditions

Allergic Rhinitis

Keywords

Prevention; Pollen; Allergy; Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• • Mini-RQLQ dimensions scores at visit 2

• Mini-RQLQ global and dimensions scores at visit 3

• Mean of the sums of nasal symptom scores at visits 2 and 3

• Mean of the sums of ocular symptom scores at visits 2 and 3

• Mean of the sums of symptomatic treatments at visits 2 and 3

Study Arms (2)

Active

EXPERIMENTAL

Lipidic Microemulsion

Device: Lipidic Microemulsion

Control

PLACEBO COMPARATOR

Saline nose-spray device

Device: Saline

Interventions

Lipidic Microemulsion DEVICE

Topical nasal, twice a day

Also known as: Blox4

Active

Saline DEVICE

Topical Nasal, twice a day

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either gender, aged 18 years or older.
• 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.
• 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).
• Providing written informed consent to participate in the study.

You may not qualify if:

• Known asthma of any origin (intrinsic or extrinsic, the latter due to any kind of allergenic trigger).
• Rhinitis or rhinoconjunctivitis of allergic characteristics presenting in the spring season but with negative allergy study (skin prick tests (SPT)).
• Asymptomatic sensitization to birch, grass or olive tree pollens.
• 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.
• Sensitization to birch, grass or olive tree pollens but only presenting with asthma symptoms.
• Concurrent participation in another clinical trial at the time of this study.
• Co-morbid conditions that, in the investigator's judgment, preclude them from participating in this study.
• Continuous treatment with antihistamines, corticosteroids, immunosuppressants or any other drug that may alter the occurrence and/or severity of allergic symptoms.

Sponsors & Collaborators

• Reig Jofre Group: lead

Study Sites (9)

Hospital General de Ciudad Real

Ciudad Real, Ciudad Real, 13005, Spain

Location

Clinica Ojeda

Madrid, Madrid, 28006, Spain

Location

Clinica Subiza

Madrid, Madrid, 28006, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Clinica Alergoasma

Salamanca, Salamanca, 37001, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, Sevilla, 41009, Spain

Location

Area Hospitalaria de Valme

Seville, Sevilla, 41014, Spain

Location

Paracelso Clínica Médico Quirúrgica

Valladolid, Valladolid, 47004, Spain

Location

Lund University Hospital

Lund, 221 85, Sweden

Location

Related Publications (1)

• 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.

  PMID: 23981504 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic; Hypersensitivity; Rhinitis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Respiratory Tract Infections; Infections

Study Officials

• Pedro Ojeda, PhD, MD

  Clínica Ojeda

  STUDY DIRECTOR

• 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

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 29, 2011

Record last verified: 2011-11

Locations

ES (8); SE (1)