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Completed

NCT Number: NCT00567346

Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.

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Key information

Conditions

Allergic Rhinoconjunctivitis Hypersensitivity Immune System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

MHAT PLovdiv, ENT Clinic, Plovdiv, Bulgaria

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About this study

Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of four treatment groups at 41 centres in Europe. Each treatment group will consist of approximately 150 patients and 150 patients will be randomized to a placebo group. The study will consist of a screening phase, a treatment phase and a variable maintenance period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male or female aged 18-50
  • patients with grass pollen related allergic rhinoconjunctivitis for at least 2 pollen seasons
  • Positive skin prick test and IgE value of at least Class 2+
  • RTSS of greater or equal to 14 during pollen season prior tot the start of the study
  • Patients must be in general good health
  • Patients with normal spirometry
  • Informed consent given and willing to comply with the protocol
  • Female patients are eligible if they use an accepted contraceptive method
  • Negative urine pregnancy test if female

Exclusion criteria

  • Pregnancy, breast feeding
  • Asthma requiring treatment other than beta-2 inhaled agonists
  • patients who have taken oral steroids within 12 weeks before screening visit
  • patients who have received desensitisation treatment for grass pollen
  • treatment by immunotherapy with any other allergen within the previous 5 years
  • patients who have suffered a lower respiratory tract infection within 4 weeks or an upper respiratory tract infection within 2 weeks of the screening visit
  • patients at risk of non-compliance
  • participation in any other clinical study within the previous 3 months
  • patients with a past or current disease, which may affect participation in or outcome of this study.
  • patients treated with beta-blockers or under continuous corticotherapy
  • allergic sensitivity to epithelial allergens the patients is exposed to
  • positive skin prick test for environmental allergens and suffering from serious allergic symptoms due to exposure to these allergens during study period
  • intention to subject the patient to surgery of the nasal cavity during current study
  • Usual contraindications of immunotherapy
  • a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of, and potentially overlapping the grass pollen season

Treatment and study plan

Oralgen

Drug

Patients will receive drops of grass pollen immunotherapy sublingually

Other names: grass pollen extract

grass pollen extract

Drug

Patients will receive matching placebo sublingually

Other names: Placebo control

Primary outcomes

  1. Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)

    Time frame: One year

Secondary outcomes

  1. Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests.

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Artu Biologicals

Industry

Registry information

Official study title

A Randomised, DB, Plcb Controlled, Multicentre, Multinational Phase II/III Study to Assess the Efficacy and Safety of Three Different Dose Regimens of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Dec 4, 2007
Registry last updated
May 5, 2010

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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