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

NCT ID: NCT01953471

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

959 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Allergic Rhinitis Due to Grass Pollen

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Allergic rhinitis

Allergic rhinitis

Intervention Type OTHER

Questionnaire

Interventions

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Allergic rhinitis

Questionnaire

Intervention Type OTHER

Eligibility Criteria

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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.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe DEVILLIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch

Locations

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Hopital Foch

Suresnes, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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2011-A00198-33

Identifier Type: OTHER

Identifier Source: secondary_id

2011/09

Identifier Type: -

Identifier Source: org_study_id