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

Allergic Rhinitis Due to Grass Pollen Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953471
• Other study ID #: 2011/09
• Secondary ID: 2011-A00198-33
• Status: Completed
• Phase: N/A
• First received: September 6, 2013
• Last updated: November 2, 2016
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 959
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Rhinitis Due to Grass Pollen
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• Allergic rhinitis
Questionnaire

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No