Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

Allergic Rhinoconjunctivitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567346
• Other study ID #: AB0602
• Secondary ID: 2006-001548-30
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 3, 2007
• Last updated: May 4, 2010
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: May 2010
• Source: Artu Biologicals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Germany: Paul-Ehrlich-InstitutCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacySlovakia: State Institute for Drug ControlBulgaria: Bulgarian Drug AgencyLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: March 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Oralgen
Patients will receive drops of grass pollen immunotherapy sublingually
• grass pollen extract
Patients will receive matching placebo sublingually

Locations

Country	Name	City	State
Bulgaria	MHAT PLovdiv, ENT Clinic	Plovdiv
Bulgaria	5th MHAT, ENT Clinic	Sofia
Bulgaria	Military Medical Academy	Sofia
Bulgaria	Ministry of interior-central clinical database	Sofia
Bulgaria	MHAT Sveta Marina	Varna
Bulgaria	Military Medical Academy	Varna
Czech Republic	ORL Soukroma praxe	Brno
Czech Republic	Fakultni nemocnice Brno	Brno-Bohunice
Czech Republic	Nemocnice Caslav	Caslav
Czech Republic	Alergologicka ordinace	Dobruska
Czech Republic	Alergologicka ambulance	Jablonec nad Nisou
Czech Republic	Alergologicka ordinace	Kutna Hora
Czech Republic	Alergologicka ambulance	Ostrava - Hrabuvka
Czech Republic	Ambulance plicni a alergologicka	Ostrave - Hrabuvka
Czech Republic	Alergologicka ambulance Okresni nemocnice Tabor	Tabor
Germany	Berufsgen. kliniken Bergmannsheil	Bochum
Germany	Univ. klinikum Carl Gustav Carus	Dresden
Germany	MedicoKIT	Goch
Germany	Johannes-Gutenberg-Universitat Mainz	Mainz
Germany	Vital Care	Muenchen
Germany	Privataertz. inst. & Forsh. einrichtung	Wiesbaden
Hungary	Svabhegyi Allami Gyermekgyogyintezet pulmonologia	Budapest
Hungary	Szent Janos Korhaz	Budapest
Hungary	Selye Janos Korhaz	Komarom
Hungary	Karolina Korhaz	Mosomagyarovar
Hungary	Tudogyogyintezet Torokbalint	Torokbalint
Lithuania	Kaunas medical University hospital	Kaunas
Lithuania	Klaipeda Regional Hospital	Klaipeda
Lithuania	JSC Seimos gydytojas	Vilnius
Lithuania	Vilnius Central Outpatient Clinic	Vilnius
Lithuania	Vilnius university hospital, Santariskiu Clinic	Vilnius
Netherlands	Ampha	De Bilt
Netherlands	Ampha	Den Bosch
Netherlands	Ampha	Hengelo
Netherlands	Menox	Nijmegen
Slovakia	Centrum imunologie a alergologie s.r.o	Bratislava
Slovakia	FNsP Nove Zamky, ambulancia TaRCh	Nove Zamky
Slovakia	Amb. klinickey imunologie a allergologie UTaRCH	Poprad
Slovakia	Ambulancia klinickej imunologie a alergologie	Trencin
Slovakia	Medcentrum s.r.o.	Zilina

Sponsors (1)

Lead Sponsor	Collaborator
Artu Biologicals

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Germany,  Hungary,  Lithuania,  Netherlands,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)		One year	No
Secondary	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	No