Efficacy and Safety of Grasspollen Sublingual Immunotherapy - Full Text View

Sponsored by:	Artu Biologicals
Information provided by:	Artu Biologicals
ClinicalTrials.gov Identifier:	NCT00567346

Purpose

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

Condition	Intervention	Phase
Rhinoconjunctivitis	Drug: grass pollen extract	Phase II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised, DB, Placebocontrolled, Multicentre, Multinational Phase II/III Study to Assess the Efficacy and Safety of Three Different Dose Regimens of Oralgen Grasspollen in Patients With Grasspollen Related Allergic Rhinoconjunctivitis

Further study details as provided by Artu Biologicals:

Primary Outcome Measures:

Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS) [ Time Frame: One year ]

Secondary Outcome Measures:

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 ]

Enrollment:	605
Study Start Date:	December 2006
Estimated Study Completion Date:	March 2008

Arms	Assigned Interventions
1: Active Comparator Current standard dose regimen of grass pollen immunotherapy, given twice weekly. Note: patients in twice weekly dosing regimen (group 1) will also receive placebo on days no active treatment is given.	Drug: grass pollen extract Patients will receive drops of grass pollen immunotherapy sublingually
2: Active Comparator Grass pollen immunotherapy, given daily	Drug: grass pollen extract Patients will receive drops of grass pollen immunotherapy sublingually
3: Active Comparator Increased dose of grass pollen immunotherapy, given daily	Drug: grass pollen extract Patients will receive drops of grass pollen immunotherapy sublingually
4: Placebo Comparator Patients randomized to placebo will receive placebo daily.	Drug: grass pollen extract Patients will receive matching placebo sublingually

Detailed Description:

Patients with seasonal grasspollen 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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 grasspollen
treatment by immunotherapy with any other allergen within the previous 5 years
patients who have suffered a lower respiratoy 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 grasspollen season

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567346

Show 41 Study Locations

Sponsors and Collaborators

Artu Biologicals

Investigators

Study Director:

Folkert R Roossien

Artu-Biologicals Europe, the Netherlands

More Information

Responsible Party:	Artu Biologicals
Study ID Numbers:	AB0602, Eudract Number: 2006-001548-30
Study First Received:	December 3, 2007
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00567346
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Germany: Paul-Ehrlich-Institut; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Slovakia: State Institute for Drug Control; Bulgaria: Bulgarian Drug Agency; Lithuania: State Medicine Control Agency - Ministry of Health

Study placed in the following topic categories:

Eye Diseases
Conjunctivitis
Conjunctival Diseases

ClinicalTrials.gov processed this record on January 16, 2009