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.
2 other identifiers
observational
959
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 6, 2013
CompletedFirst Posted
Study publicly available on registry
October 1, 2013
CompletedNovember 3, 2016
November 1, 2016
5 months
September 6, 2013
November 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Allergic rhinitis
Interventions
Eligibility Criteria
Patients with allergic rhinitis due to grass pollen
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (1)
Hopital Foch
Suresnes, Île-de-France Region, 92150, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe DEVILLIER, MD, PhD
Hôpital Foch
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2013
First Posted
October 1, 2013
Study Start
April 1, 2011
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
November 3, 2016
Record last verified: 2016-11