Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

Phase 2

Completed

• Conditions: Allergic Rhinoconjunctivitis
• Interventions: Drug: Oralgen; Drug: grass pollen extract

• Registration Number: NCT00567346
• Lead Sponsor: Artu Biologicals

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-10
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-04
• Study Completion: 2008-03
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-04
• Last Update Posted: 2010-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 605

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
grass pollen extract twice weekly	Oralgen	Current standard dose regimen of grass pollen immunotherapy (9,500 BU), given twice weekly. Note: patients in twice weekly dosing regimen will also receive placebo on days no active treatment is given.
Grass pollen extract, daily	Oralgen	Grass pollen immunotherapy, 9,500 BU, given daily
Increased dose of grass pollen extract	Oralgen	Increased dose of grass pollen immunotherapy, 19,000 BU, given daily
Placebo control	grass pollen extract	Patients randomized to placebo will receive placebo daily.

Primary Outcome Measures

Name	Time	Method
Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)	One year

Secondary Outcome Measures

Name	Time	Method
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.	one year

Trial Locations

Locations (35)

MHAT PLovdiv, ENT Clinic; 🇧🇬 Plovdiv, Bulgaria

5th MHAT, ENT Clinic; 🇧🇬 Sofia, Bulgaria

Military Medical Academy; 🇧🇬 Varna, Bulgaria

Ministry of interior-central clinical database; 🇧🇬 Sofia, Bulgaria

MHAT Sveta Marina; 🇧🇬 Varna, Bulgaria

Fakultni nemocnice Brno; 🇨🇿 Brno-Bohunice, Czech Republic

ORL Soukroma praxe; 🇨🇿 Brno, Czech Republic

Nemocnice Caslav; 🇨🇿 Caslav, Czech Republic

Alergologicka ordinace; 🇨🇿 Kutna Hora, Czech Republic

Alergologicka ambulance; 🇨🇿 Ostrava - Hrabuvka, Czech Republic

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