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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01953471

Enrollment

959

Registered

2013-10-01

Start date

2011-04-30

Completion date

2011-12-31

Last updated

2016-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis Due to Grass Pollen

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.

Interventions

OTHERAllergic rhinitis

Questionnaire

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026