International Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis

NCT02041624 | Terminated DMC

• 1 other identifier: ORA-PES-05-WO
• Study Type: observational
• Target: 740
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to describe patient's perception of quality of life and effectiveness of ORALAIR® over a follow-up period up to 5 years, in real-life settings.

Conditions

Allergic Rhinitis Due to Grass Pollens

Keywords

allergic; rhinitis; conjunctivitis; grass pollen; Allergen ImmunoTherapy (AIT); grass mix

Outcome Measures

Primary Outcomes (1)

• Health related quality of life

  The primary objective is to describe the patient's perception of the impact of ORALAIR® on his/her health related generic and disease specific quality of life during the grass-pollen season in real-life settings.

  patients will be followed for the duration of the treatment, an expected average of 6 months/year

Secondary Outcomes (1)

• Treatment Effectiveness

  patients will be followed for the duration of the treatment, an expected average of 6 months/year

Study Arms (1)

allergic rhino-conjunctivitis

Patient with proven allergic rhino-conjunctivitis due to grass pollen

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with allergic rhino-conjunctivitis are visiting their allergist during grass-pollen season when symptoms are strong. In accordance with the terms of the Marketing Authorization, ORALAIR® treatment has to be set-up "at the right moment" about 4 months before the next grass-pollen season.

You may qualify if:

• Patient of 5 years of age and older at the date of the screening visit
• Patient with proven allergic rhino-conjunctivitis due to grass pollen
• Patient eligible for a grass-pollen Allergen ImmunoTherapy (AIT)
• Patient whose physician prescribed ORALAIR® independently of the study, before the beginning of the grass-pollen season

You may not qualify if:

• Patient participating in a clinical trial or in an epidemiological study

Sponsors & Collaborators

• Stallergenes Greer: lead
• Registrat-Mapi: collaborator

Study Sites (1)

Laboratoire Stallergenes

Antony, 92183, France

Location

MeSH Terms

Conditions

Rhinitis; Conjunctivitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Conjunctival Diseases; Eye Diseases

Study Officials

• Alain DIDIER, MD

  Hôpital Larrey, Toulouse, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 22, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 18, 2016

Record last verified: 2016-04

Locations

FR (1)