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Prospective Observational Study for Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen (Equinoxe 2)

Completed
Conditions
Allergic Rhinitis Due to Grass Pollen
Interventions
Other: Allergic rhinitis
Registration Number
NCT01953471
Lead Sponsor
Hopital Foch
Brief Summary

Prospective multi-center study carried out in France involving patients with allergic rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
959
Inclusion Criteria
  • Male or female patients aged between 6 and 65 years.
  • Patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study in accordance with local laws and requirements.
  • Patient with an Grass pollen-related allergic rhinitis (immunologically and / or symptomatically treated or non treated).
  • Patients presented for symptomatic management of allergic rhinitis.
  • Patients having Symptoms score ≥ 6.
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Exclusion Criteria
  • Patients involved in any other clinical/observational study.
  • patients unable to fill in the study questionnaires.
  • Patient suffering from any diagnosed disease that may interfere with the evaluation of allergic rhinoconjunctivitis' related quality of life, fatigue and daily activities.
  • Patients treated with any drug that may influence the patient's fatigue and/or interfere with psychomotor performance.
  • Patients suffering from persistent asthma, or asthma exacerbation during grass pollen season.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Allergic rhinitisAllergic rhinitis-
Primary Outcome Measures
NameTimeMethod
Rhinitis Total Symptoms Score (RTSS), (intensity of each symptom measured on a 4-point scale) compared to a 15-point global rating of change questionnaire.6 months per patient
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hopital Foch

🇫🇷

Suresnes, Ile de France, France

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