2nd pivotal study rPhleum adults &adolescents with rhinoconjunctivitis

• Research type

  Research Study

• Full title

  Randomised double blind placebo-controlled pivotal study to evaluate efficacy and safety of rPhleum in adult and adolescent patients suffering from rhinoconjunctivitis +/- controlled Asthma

• IRAS ID

  29319

• Contact name

  Anthony J Frew

• Sponsor organisation

  Allergopharma GmbH & Co. KG

• Eudract number

  2009-011504-36

• ISRCTN Number

  n/a

• Research summary

  This is a randomised, double-blind, placebo-controlled, pivotal study to evaluate efficacy and safety of rPhleum in adult and adolescent patients suffering from rhinoconjunctivitis (inflammation & irritation of the nose and eyes) with or without controlled Asthma.Pollen from wind-pollinated plants e.g. trees, grasses and weeds represent the most frequent and potent causes of allergy that cannot be avoided. Grass pollen allergy affects more than 25% of the population.As avoidance of grass pollen allergens is hardly possible, current treatment is antihistamines which reduce allergic symptoms during the time period of application.Specific immunotherapy (SIT) or allergen vaccination, is the practice of administering gradually increasing quantities of an allergen or allergen cocktail to an allergic individual to reduce the symptoms associated with the subsequent exposure to the causative allergen.SIT is the only treatment that may affect the natural cause of allergic diseases, and it also may prevent the development of asthma in patients with allergic rhinitis.This study is to evaluate the efficiency and tolerability (the frequency of side effects) of a specific immunotherapy (SIT) given as an injection containing a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) in subjects with rhinoconjunctivitis caused by grass pollen with/without controlled asthma.The drug under investigation is a cocktail of highly pure and exactly defined substances. As a consequence of this trial, specific immunotherapy might become better defined and safer.The trial will be conducted in about 65 European centres in allergy-specialised hospitals, general practitioners, or allergologists.It is estimated to randomise 230 patients. Patients will be recruited between October 2009 and May 2010, treated between November 2010 and December 2012 and the study will end in August 2015.For each subject the trial will start with a baseline period, followed by two additional assessment periods.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/104

• Date of REC Opinion

  9 Dec 2009

• REC opinion

  Further Information Favourable Opinion