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

NCT01731249 | Completed Phase 3 DMC

• 2 other identifiers: VO68.102010-020693-42
• Study Type: interventional
• Target: 574
• Locations: 11 countries
• Sites: 11

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

Outcome Measures

Primary Outcomes (1)

• Average Adjusted Symptom Score

  Symptom score adjusted on patient's rescue medication usage

  Year 2 of treatment

Secondary Outcomes (19)

• Average Rhinoconjunctivitis Total Symptom Score

  Year 2 of treatment

• Average Rescue Medication Score

  Year 2 of treatment

• Each of Six Individual Average Rhinoconjunctivitis Symptom Scores

  Year 2 of treatment

• Average Combined Score

  Year 2 of treatment

• Average Rhinoconjunctivitis Visual Analogue Scale Score

  Year 2 of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo sublingual solution

Biological: Placebo

Birch pollen allergen extract

EXPERIMENTAL

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

Biological: Birch pollen allergen extract

Interventions

Placebo BIOLOGICAL

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

Placebo

Birch pollen allergen extract BIOLOGICAL

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

Also known as: Staloral Birch

Birch pollen allergen extract

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stallergenes Greer: lead
• Quintiles, Inc.: collaborator
• Aptuit: collaborator
• Cenduit LLC: collaborator
• PHT Corporation: collaborator

Study Sites (11)

Alergologicka ordinace

Pilsen, 30100, Czechia

Location

National University Hospital - Allergy Unit 4222

Copenhagen, 2100, Denmark

Location

Merekivi Perearstid OÜ

Tallinn, 10617, Estonia

Location

Helsingin yliopistollinen keskussairaala

Helsinki, 00029, Finland

Location

NHC, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Universitätsmedizin Berlin - Allergie-Centrum-Charité

Berlin, 10117, Germany

Location

Centre of Investigations and Treatment of Allergic Diseases

Riga, 1003, Latvia

Location

Allergic Diseases Diagnostics and Treatment Centre

Vilnius, 08109, Lithuania

Location

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

Lodz, 90-153, Poland

Location

Imunologicko-alergologicka amb.

Banská Bystrica, 975 17, Slovakia

Location

Sahlgrenska Universitetssjukhuset - Avd för Lungmedicin och Allergi

Gothenburg, 413 45, Sweden

Location

Related Publications (1)

• 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.

  PMID: 24517417 DERIVED

MeSH Terms

Conditions

Hypersensitivity; Rhinitis, Allergic; Conjunctivitis, Allergic; Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Officials

• Margitta WORM, MD, PR

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: November 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

DK (1); LI (1); LA (1); FI (1); ES (1); PL (1); SE (1); CZ (1); SL (1); DE (1); FR (1)