Status:
COMPLETED
Efficacy and Tolerability of a Topical Microemulsion in Patients With Allergic Rhinitis Due to Sensitization to Pollen
Lead Sponsor:
Reig Jofre Group
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 per...
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@t...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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.
Exclusion
- Known asthma of any origin (intrinsic or extrinsic, the latter due to any kind of allergenic trigger).
- 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).
- 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.
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01478425
Start Date
March 1 2011
End Date
August 1 2011
Last Update
November 29 2011
Active Locations (9)
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1
Hospital General de Ciudad Real
Ciudad Real, Ciudad Real, Spain, 13005
2
Clinica Ojeda
Madrid, Madrid, Spain, 28006
3
Clinica Subiza
Madrid, Madrid, Spain, 28006
4
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain, 31008