Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis

NCT ID: NCT01731249

Last Updated: 2012-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 574 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-10-31

Brief Summary

The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.

Conditions

Hypersensitivity; Allergic Rhinitis; Allergic Conjunctivitis; Seasonal Allergy

Keywords

Sublingual immunotherapy; Birch pollen extract solution; Allergic rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo sublingual solution

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

10 actuations of placebo sublingual solution once daily 5 months a year and during 2 years

Birch pollen allergen extract

Sublingual Solution of Birch pollen allergen extract 300IR once daily 5 months per year and during 2 years

Group Type: EXPERIMENTAL

Birch pollen allergen extract

Intervention Type: BIOLOGICAL

Sublingual solution of Birch pollen allergen extract 300IR (10 actuations) once daily 5 months per year and during 2 years

Interventions

Placebo

10 actuations of placebo sublingual solution once daily 5 months a year and during 2 years

Intervention Type: BIOLOGICAL

Birch pollen allergen extract

Sublingual solution of Birch pollen allergen extract 300IR (10 actuations) once daily 5 months per year and during 2 years

Intervention Type: BIOLOGICAL

Other Intervention Names

Staloral Birch

Eligibility Criteria

Inclusion Criteria

• Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the previous 2 pollen seasons requiring intake of symptomatic treatment.
• Sensitization to birch pollen demonstrated by a positive Skin Prick Test to birch pollen with wheal diameter > 3 mm and birch pollen allergens specific IgE levels ≥ 0.70 kU/L.
• RRTSS based on the previous or on the penultimate birch pollen season ≥ 12 out of a maximum possible score of 18.
• Patients with an FEV1 (Forced Expiratory Volume at one second) ≥ 80% of the predicted value.
• Patients who are willing to comply with the protocol.
• Patients having given a signed informed consent before completing any study related procedure.

Exclusion Criteria

• Patients with symptoms of rhinitis/rhinoconjunctivitis during the birch pollen season due to any other allergens (except alder and hazel). This includes patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study.
• Patient who previously received desensitization treatment to birch pollen and/or another Betulaceae sp. (for example hazel or alder) within the previous 5 years.
• Patients with ongoing treatment by immunotherapy with another allergen.
• Pregnancy (positive pregnancy test), breast-feeding.
• Female patients of childbearing potential planning a pregnancy during this study or not using a medically accepted contraceptive method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner).
• Patients planning to move during the study or planning to leave the area during the birch pollen season for more than 1 week (7 consecutive days).
• Patients with moderate or severe persistent asthma (GINA 3 or 4).
• Patients with seasonal mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a dose level greater than 400 mcg budesonide dose-equivalents.
• Patients with any nasal or oral condition that could interfere with the efficacy or safety assessments (such as nasal polyposis or oral inflammation).
• Patients with severe immune deficiency.
• Patients with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or outcome of this study.
• Any other disease or condition which would place a patient at undue risk by being included in the study (according to the Investigator's opinion).
• Usual contra-indications of immunotherapy such as concomitant beta-blocker therapy whatever the route and/or immunosuppressive drugs.
• Patients treated with inhaled/systemic steroids (whatever the indication) within 4 weeks prior to Visit 1 (Screening), or with long acting systemic corticosteroids 12 weeks before Visit 1 (Screening).
• Patients under continuous corticotherapy (inhaled or systemic drugs).
• Patients following a strict low sodium diet as the study treatment contains 590 mg of sodium chloride per vial in a 10 mL solution.
• Investigators, co-Investigators, as well as their children or spouses and all study collaborators.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Aptuit

INDUSTRY

Sponsor Role: collaborator

Cenduit LLC

INDUSTRY

Sponsor Role: collaborator

PHT Corporation

INDUSTRY

Sponsor Role: collaborator

Stallergenes Greer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margitta WORM, MD, PR

Role: PRINCIPAL_INVESTIGATOR

Allergie-Centrum-Charité, Klinik für Dermatologie, Venerologie und Allergologie, Charité Campus Mitte, Universitätsmedizin, Charitéplatz 1, 10117 Berlin, Germany

Locations

Alergologicka ordinace

Pilsen, , Czechia

National University Hospital - Allergy Unit 4222

Copenhagen, , Denmark

Merekivi Perearstid OÜ

Tallinn, , Estonia

Helsingin yliopistollinen keskussairaala

Helsinki, , Finland

NHC, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Universitätsmedizin Berlin - Allergie-Centrum-Charité

Berlin, , Germany

Centre of Investigations and Treatment of Allergic Diseases

Riga, , Latvia

Allergic Diseases Diagnostics and Treatment Centre

Vilnius, , Lithuania

SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi

Lodz, , Poland

Imunologicko-alergologicka amb.

Banská Bystrica, , Slovakia

Sahlgrenska Universitetssjukhuset - Avd för Lungmedicin och Allergi

Gothenburg, , Sweden

Countries

Czechia; Denmark; Estonia; Finland; France; Germany; Latvia; Lithuania; Poland; Slovakia; Sweden

References

Worm M, Rak S, de Blay F, Malling HJ, Melac M, Cadic V, Zeldin RK. Sustained efficacy and safety of a 300IR daily dose of a sublingual solution of birch pollen allergen extract in adults with allergic rhinoconjunctivitis: results of a double-blind, placebo-controlled study. Clin Transl Allergy. 2014 Feb 11;4(1):7. doi: 10.1186/2045-7022-4-7.

Reference Type: DERIVED

PMID: 24517417 (View on PubMed)

Other Identifiers

2010-020693-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VO68.10

Identifier Type: -

Identifier Source: org_study_id