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

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.

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Key information

Conditions

Allergic Rhinitis Due to Grass Pollen

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Foch

Suresnes, Île-de-France Region, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Allergic rhinitis

Other

Questionnaire

Primary outcomes

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.

Time frame: 6 months per patient

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen by the Assessment of the Relationship Between the Symptom Scores and Global Rating of Change Questionnaires on the Quality of Life and Well-being.

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Oct 1, 2013
Registry last updated: Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed