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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01731249
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : November 27, 2012
Quintiles, Inc.
Aptuit Inc.
Cenduit LLC
PHT Corporation
Information provided by (Responsible Party):
Stallergenes Greer

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.

Condition or disease Intervention/treatment Phase
Hypersensitivity Allergic Rhinitis Allergic Conjunctivitis Seasonal Allergy Biological: Placebo Biological: Birch pollen allergen extract Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 574 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Multi-national, Phase IIIb Study to Assess the Sustained Clinical Effect and Safety of Sublingual Immunotherapy Administered as Birch Pollen Extract Solution at a Dose of 300 IR Once Daily to Patients Suffering From Birch Pollen-induced Rhinoconjunctivitis
Study Start Date : November 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo sublingual solution
Biological: Placebo
10 actuations of placebo sublingual solution once daily 5 months a year and during 2 years
Experimental: Birch pollen allergen extract
Sublingual Solution of Birch pollen allergen extract 300IR once daily 5 months per year and during 2 years
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
Other Name: Staloral Birch

Primary Outcome Measures :
  1. Average Adjusted Symptom Score [ Time Frame: Year 2 of treatment ]
    Symptom score adjusted on patient's rescue medication usage

Secondary Outcome Measures :
  1. Average Rhinoconjunctivitis Total Symptom Score [ Time Frame: Year 2 of treatment ]
  2. Average Rescue Medication Score [ Time Frame: Year 2 of treatment ]
  3. Each of Six Individual Average Rhinoconjunctivitis Symptom Scores [ Time Frame: Year 2 of treatment ]
  4. Average Combined Score [ Time Frame: Year 2 of treatment ]
  5. Average Rhinoconjunctivitis Visual Analogue Scale Score [ Time Frame: Year 2 of treatment ]
  6. Average Adjusted Visual Analogue Scale Score [ Time Frame: Year 2 of treatment ]
  7. Rescue Medication Usage [ Time Frame: Year 2 of treatment ]
  8. Proportion of Symptom-controlled Days [ Time Frame: Year 2 of treatment ]
  9. Rhinoconjunctivitis Quality of Life Questionnaire [ Time Frame: Year 2 of treatment ]
  10. Global evaluation of the efficacy by the patient [ Time Frame: Year 2 of treatment ]
  11. Sensitization profile [ Time Frame: Before and after each treatment period (over 2 years) ]
    sensitization profile (mono- vs poly-sensitized) is derived from the skin prick test results

  12. Asthma [ Time Frame: Before, during and after each pollen season (over 2 years) ]
  13. Immunological markers specific for birch pollen [ Time Frame: Before and after each treatment period (over 2 years) ]
  14. Economical Evaluation [ Time Frame: Year 2 of treatment ]
    Proportion of days-off due to birch pollen-induced symptoms

  15. Wheal diameter of the birch allergen Skin prick test [ Time Frame: Before and after each treatment period (over 2 years) ]
  16. Oral Provocation Test [ Time Frame: Year 2 of treatment ]
    Analysis on a subset of patients presenting an Oral Allergy Syndrome at study entry

  17. Mucosa Local Inflammation [ Time Frame: Year 1 of treatment ]
    Analysis on a subset of patients

  18. Safety assessments [ Time Frame: ~20 months ]
    adverse events, physical examination including vital signs and laboratory data described by number of patients in each treatment group

  19. Average adjusted Symptom score analysis by tertiles [ Time Frame: Year 2 of treatment ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01731249

Czech Republic
Alergologicka ordinace
Plzen, Czech Republic, 30100
National University Hospital - Allergy Unit 4222
Copenhagen, Denmark, 2100
Merekivi Perearstid OÜ
Tallinn, Estonia, 10617
Helsingin yliopistollinen keskussairaala
Helsinki, Finland, 00029
NHC, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Universitätsmedizin Berlin - Allergie-Centrum-Charité
Berlin, Germany, 10117
Centre of Investigations and Treatment of Allergic Diseases
Riga, Latvia, 1003
Allergic Diseases Diagnostics and Treatment Centre
Vilnius, Lithuania, 08109
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
Lodz, Poland, 90-153
Imunologicko-alergologicka amb.
Banska Bystrica, Slovakia, 975 17
Sahlgrenska Universitetssjukhuset - Avd för Lungmedicin och Allergi
Göteborg, Sweden, 413 45
Sponsors and Collaborators
Stallergenes Greer
Quintiles, Inc.
Aptuit Inc.
Cenduit LLC
PHT Corporation
Principal Investigator: Margitta WORM, MD, PR Allergie-Centrum-Charité, Klinik für Dermatologie, Venerologie und Allergologie, Charité Campus Mitte, Universitätsmedizin, Charitéplatz 1, 10117 Berlin, Germany

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stallergenes Greer Identifier: NCT01731249     History of Changes
Other Study ID Numbers: VO68.10
2010-020693-42 ( EudraCT Number )
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Stallergenes Greer:
Sublingual immunotherapy
Birch pollen extract solution
Allergic rhinoconjunctivitis

Additional relevant MeSH terms:
Rhinitis, Allergic
Conjunctivitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Pharmaceutical Solutions