Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis

Last updated: November 14, 2012
Sponsor: ALK-Abelló A/S
Overall Status: Completed

Phase

3

Condition

Rhinitis, Allergic, Perennial

Acute Rhinitis

Allergy (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01728285
GT-17 ITALY
2006-004820-35
  • Ages 18-65
  • All Genders

Study Summary

Adherence to treatment is crucial to the efficacy of sublingual immunotherapy of allergic diseases. GRAZAX® is a registered drug in Europe, with established efficacy in the treatment of allergic rhinitis, which has to be taken daily by patients. This study was aimed to establish if a device with the characteristics of a mechanical dispenser (Memozax®) could improve adherence to treatment in subjects with hay fever due to allergy to grass

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A clinical history of grass pollen-induced allergic rhinoconjunctivitis (with orwithout asthma) having received treatment during the previous grass pollen season.

  • Positive skin prick test (SPT) response (wheal diameter ≥3mm) to Phleum pratense

  • Positive specific IgE against Phleum pratense (IgE titer > class 2)

Exclusion

Exclusion Criteria:

  • Clinical history of chronic sinusitis during the last 2 years or of symptomaticperennial or seasonal allergic rhinitis and/or asthma having received regularmedication, due to another allergen during - or potentially overlapping - the grasspollen season.

  • Clinical history of severe asthma (GINA Step 4 and children with Forced ExpiratoryVolume in 1 second (FEV1) < 80% of expected value after treatment with inhaledcorticosteroids and short-acting β2 agonists)

  • Previous treatment by immunotherapy with grass pollen allergen or any other allergenwithin the previous 5 years

Study Design

Total Participants: 261
Study Start date:
March 01, 2007
Estimated Completion Date:
October 31, 2009

Connect with a study center

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, PV 27100
    Italy

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.