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
Group Intervention Description Allergic rhinitis Allergic rhinitis -
- Primary Outcome Measures
Name Time Method 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
Name Time Method
Trial Locations
- Locations (1)
Hopital Foch
🇫🇷Suresnes, Ile de France, France