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

Allergic Rhinitis Due to Grass Pollens Clinical Trial

— ALTO  

Official title:

An International Non-Interventional Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis Treated With Oralair®.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02041624
• Other study ID #: ORA-PES-05-WO
• Status: Terminated
• Phase: N/A
• First received: January 14, 2014
• Last updated: April 15, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareBelgium: Ethics CommitteeFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Conseil National de l'Ordre des MédecinsFrance: The Commission nationale de l’informatique et des libertésGermany: Paul-Ehrlich-InstitutGermany: Ethics CommissionItaly: The Italian Medicines AgencyItaly: Ethics CommitteeNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Independent Ethics CommitteeRussia: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Ethics CommitteeSwitzerland: EthikkommissionSwitzerland: Internal Review Board Inselspital
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Primary objective:

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.

Secondary objectives:

• To describe the patient's perceived effectiveness of ORALAIR® in allergic rhinoconjunctivitis management in terms of disease intensity, satisfaction and rescue medication

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 740
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Rhinitis Due to Grass Pollens
• Rhinitis

Locations

Country	Name	City	State
France	Laboratoire Stallergenes	Antony

Sponsors (2)

Lead Sponsor	Collaborator
Stallergenes	Registrat-Mapi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Treatment Effectiveness	To describe the patient's perceived effectiveness of ORALAIR® in allergic rhino-conjunctivitis management in terms of disease intensity, satisfaction and rescue medication	patients will be followed for the duration of the treatment, an expected average of 6 months/year	No