Oralgen® Protocol number:AB0801/Phase 3/Allergic Rhinoconjunctivitis

• Research type

  Research Study

• Full title

  A Randomized,double - blind,placebo controlled, long term Phase III study to assess the efficacy and safety of Oralgen Grass Pollen in patients with grass pollen related allergic rhinoconjunctivitis.

• IRAS ID

  7887

• Contact name

  Folkert Rossien

• Sponsor organisation

  Artu Biologicals Europe B.V.

• Eudract number

  2008-004825-40

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Allergic rhinitis/rhinoconjunctivitis (Hay Fever) is the most prevalent of allergic diseases and there is mounting evidence of a rise in the prevalence of allergic diseases including rhinitis over recent decades. During the pollen season, patients with hay fever complain of sneezing, have a runny or stuffy nose, their nose and eyes may itch and their eyes may water. These symptoms may impair usual daily activities, quality of sleep and productivity. Allergic Rhinitis is frequently associated with co-morbidities (other illnesses) including asthma. By treating patients suffering from hay fever with sublingual (under the tongue) immunotherapy, it is hoped to flunce the reaction of the body to substances that cause an allergic reaction (immune response). This study is designed to give some information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, as drops placed under the tongue, in patients suffering from hay fever during the grass pollen season. The safety and tolerability of the sublingual immunotherapy will be determined by different blood tests as well as by recording the local (in the mouth and face) and systemic (in the body) effects and other side effects (adverse events)

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  08/H0408/170

• Date of REC Opinion

  4 Dec 2008

• REC opinion

  Further Information Favourable Opinion