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Completed

NCT Number: NCT01728285

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

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

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Key information

Conditions

Allergic Rhinitis Behavior Grass Allergy Health Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Patient Acceptance of Health Care Patient Compliance Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A clinical history of grass pollen-induced allergic rhinoconjunctivitis (with or without 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 criteria

  • Clinical history of chronic sinusitis during the last 2 years or of symptomatic perennial or seasonal allergic rhinitis and/or asthma having received regular medication, due to another allergen during - or potentially overlapping - the grass pollen season.
  • Clinical history of severe asthma (GINA Step 4 and children with Forced Expiratory Volume in 1 second (FEV1) < 80% of expected value after treatment with inhaled corticosteroids and short-acting β2 agonists)
  • Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years

Treatment and study plan

Electronic compliance device (Memozax®)

Device

An electronic compliance device is distributed to patients allocated to the active arm

Primary outcomes

  1. To evaluate if compliance with grass Allergy Immunotherapy Tablet can be increased by providing an electronic compliance device (CED) (Memozax; a tablet-container with a programmable daily acoustic alarm)

    Time frame: up to 1 year per patient

    To evaluate if compliance of once daily dosing with Grazax in adult subjects with grass pollen induced allergic rhinoconjunctivitis can be increased by providing patients with an electronic compliance device. Compliance in the two groups (with Memozax and without Memozax) was evaluated by tablet counts

Secondary outcomes

  1. Impact of GRAZAX® treatment on QoL as compared to previous season

    Time frame: up to 1 year per patient

    To evaluate after one-year treatment with Grazax tablets the impact on quality of life in comparison with previous pollen seasons

  2. Impact of GRAZAX® treatment on allergy symptoms as compared to previous season

    Time frame: up to 1 year per patient

    To evaluate after one-year treatment with Grazax tablets the impact on symptom score in comparison with previous pollen seasons

  3. Impact of GRAZAX® on treatment acceptance as compared to previous season

    Time frame: up to 1 year per patient

    To evaluate after one-year treatment with Grazax tablets the impact on patient's acceptance in comparison with previous pollen seasons

  4. Recording of all adverse events and serious adverse events

    Time frame: up to 1 year per patient

    The safety assessments included recording of all adverse events (AE) and serious adverse events (SAE) findings from physical examinations and from vital signs

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study title

A Multicentric Open Randomised, Cross-over Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Acronym: GT-17

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2012
Registry last updated
Nov 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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