ALTO, An international non-interventional registry on the quality of life of patients with grass pollen-induced Allergic Rhinitis Treated with Oralair®

Study identification

• EU PAS number:
  EUPAS6076
• Study ID:
  9749
• Official title and acronym:
  ALTO, An international non-interventional registry on the quality of life of patients with grass pollen-induced Allergic Rhinitis Treated with Oralair®
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Italy

  Netherlands

  Russian Federation

  Spain

  Switzerland
• Study description:
  Results from clinical trials need to be complemented with real-life information on short-, mid- and long-term outcome in patients treated with Oralair®. The purpose of the present study is therefore to describe the patient’s perception of quality of life and effectiveness of Oralair® over a follow-up period of up to 5 years, in real-life settings.This is a five-year international, prospective, observational, multicentre, longitudinal, pharmacoepidemiological study.The study will be conducted in 2 phases:- 1st Phase (Screening visit):During the 2014 grass-pollen season, investigators will consecutively include all patients meeting the selection criteria of the 1st Phase. This 1st phase is meant to collect data during grass-pollen season in patients with allergic rhino-conjunctivitis and without any AIT treatment.- 2nd Phase (Longitudinal Study): Investigators will include in the 2nd Phase of the study all patients of the 1st phase starting a treatment with Oralair® approximately 4 months before the 2015 grass-pollen season. Patients will be followed-up in accordance with the normal course of patient care. Follow-up visits are routinely performed twice a year approximately (depending upon local usual practices).Patients (and/or, in the case of a minor, his/her parents or legally acceptable representatives) will be asked to complete Patient Booklets about treatment compliance, Quality of Life and disease intensity at Screening visit (V0) and at home during each pollen season.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pr. Alain DIDIER

UZ Gent, Dr. Gevaert Belgium, CHR Namur, Dr. Bradatan Belgium, Hopital Larrey, Toulouse, Dr. Mailhol France, Dr. M. Hoffmann, Witten Germany, Città della Salute Hospital, Torino, Dr. Marengo Italy, Moscow City Hospital N°57, Dr. Novikova Russia, Hospital Virgen de la Vega, Dr. Muñoz Bellido Spain, Luzerner Kantonsspital, Luzern, Dr. Müllner Switzerland

Study timelines

Date when funding contract was signed

Planned:01/11/2013

Actual:02/12/2013

Study start date

Planned:01/04/2014

Actual:19/05/2014

Data analysis start date

Planned:30/09/2015

Date of interim report, if expected

Planned:30/09/2016

Date of final study report

Planned:30/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Stallergenes SA

Regulatory

• Was the study required by a regulatory body?:
  No