Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

NCT00567346 | Completed Phase 2 DMC

• 2 other identifiers: AB06022006-001548-30
• Study Type: interventional
• Target: 605
• Locations: 7 countries
• Sites: 40

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.

Conditions

Allergic Rhinoconjunctivitis

Keywords

randomised; double-blind; placebo-controlled; efficacy and safety; Oralgen® Grass Pollen; allergic rhinoconjunctivitis; Allergy; Rhinoconjunctivitis; Immunotherapy; Grass pollen extract

Outcome Measures

Primary Outcomes (1)

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

  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.

  one year

Study Arms (4)

grass pollen extract twice weekly

ACTIVE COMPARATOR

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.

Drug: Oralgen

Grass pollen extract, daily

ACTIVE COMPARATOR

Grass pollen immunotherapy, 9,500 BU, given daily

Drug: Oralgen

Increased dose of grass pollen extract

ACTIVE COMPARATOR

Increased dose of grass pollen immunotherapy, 19,000 BU, given daily

Drug: Oralgen

Placebo control

PLACEBO COMPARATOR

Patients randomized to placebo will receive placebo daily.

Drug: grass pollen extract

Interventions

Oralgen DRUG

Patients will receive drops of grass pollen immunotherapy sublingually

Also known as: grass pollen extract

Grass pollen extract, daily; Increased dose of grass pollen extract; grass pollen extract twice weekly

grass pollen extract DRUG

Patients will receive matching placebo sublingually

Also known as: Placebo control

Placebo control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Artu Biologicals: lead

Study Sites (40)

MHAT PLovdiv, ENT Clinic

Plovdiv, Bulgaria

Location

5th MHAT, ENT Clinic

Sofia, Bulgaria

Location

Military Medical Academy

Sofia, Bulgaria

Location

Ministry of interior-central clinical database

Sofia, Bulgaria

Location

MHAT Sveta Marina

Varna, Bulgaria

Location

Military Medical Academy

Varna, Bulgaria

Location

ORL Soukroma praxe

Brno, Czechia

Location

Fakultni nemocnice Brno

Brno-Bohunice, Czechia

Location

Nemocnice Caslav

Čáslav, Czechia

Location

Alergologicka ordinace

Dobruška, Czechia

Location

Alergologicka ambulance

Jablonec nad Nisou, Czechia

Location

Alergologicka ordinace

Kutná Hora, Czechia

Location

Alergologicka ambulance

Ostrava - Hrabuvka, Czechia

Location

Ambulance plicni a alergologicka

Ostrave - Hrabuvka, Czechia

Location

Alergologicka ambulance Okresni nemocnice Tabor

Tábor, Czechia

Location

Berufsgen. kliniken Bergmannsheil

Bochum, Germany

Location

Univ. klinikum Carl Gustav Carus

Dresden, Germany

Location

MedicoKIT

Goch, Germany

Location

Johannes-Gutenberg-Universitat Mainz

Mainz, Germany

Location

Vital Care

München, Germany

Location

Privataertz. inst. & Forsh. einrichtung

Wiesbaden, Germany

Location

Svabhegyi Allami Gyermekgyogyintezet pulmonologia

Budapest, Hungary

Location

Szent Janos Korhaz

Budapest, Hungary

Location

Selye Janos Korhaz

Komárom, Hungary

Location

Karolina Korhaz

Mosomagyarovar, Hungary

Location

Tudogyogyintezet Torokbalint

Törökbálint, Hungary

Location

Kaunas medical University hospital

Kaunas, Lithuania

Location

Klaipeda Regional Hospital

Klaipėda, Lithuania

Location

JSC Seimos gydytojas

Vilnius, Lithuania

Location

Vilnius Central Outpatient Clinic

Vilnius, Lithuania

Location

Vilnius university hospital, Santariskiu Clinic

Vilnius, Lithuania

Location

Ampha

's-Hertogenbosch, Netherlands

Location

Ampha

De Bilt, Netherlands

Location

Ampha

Hengelo, Netherlands

Location

Menox

Nijmegen, Netherlands

Location

Centrum imunologie a alergologie s.r.o

Bratislava, Slovakia

Location

FNsP Nove Zamky, ambulancia TaRCh

Nové Zámky, Slovakia

Location

Amb. klinickey imunologie a allergologie UTaRCH

Poprad, Slovakia

Location

Ambulancia klinickej imunologie a alergologie

Trenčín, Slovakia

Location

Medcentrum s.r.o.

Žilina, Slovakia

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

grass pollen extract, alum-adsorbed

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Folkert R Roossien

  Artu-Biologicals Europe B.V., the Netherlands

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 4, 2007
• Study Start: December 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: March 1, 2008
• Last Updated: May 5, 2010

Record last verified: 2010-05

Locations

SL (5); CZ (9); LI (5); BU (6); DE (6); HU (5); NL (4)