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

This study has been completed.
Sponsor:
Collaborators:
Quintiles
Aptuit Inc.
Cenduit LLC
PHT Corporation
Information provided by (Responsible Party):
Stallergenes
ClinicalTrials.gov Identifier:
NCT01731249
First received: November 15, 2012
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Hypersensitivity
Allergic Rhinitis
Allergic Conjunctivitis
Seasonal Allergy
Biological: Placebo
Biological: Birch pollen allergen extract
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • Average Adjusted Symptom Score [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
    Symptom score adjusted on patient's rescue medication usage


Secondary Outcome Measures:
  • Average Rhinoconjunctivitis Total Symptom Score [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
  • Average Rescue Medication Score [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
  • Each of Six Individual Average Rhinoconjunctivitis Symptom Scores [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
  • Average Combined Score [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
  • Average Rhinoconjunctivitis Visual Analogue Scale Score [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
  • Average Adjusted Visual Analogue Scale Score [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
  • Rescue Medication Usage [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
  • Proportion of Symptom-controlled Days [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
  • Rhinoconjunctivitis Quality of Life Questionnaire [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
  • Global evaluation of the efficacy by the patient [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
  • Sensitization profile [ Time Frame: Before and after each treatment period (over 2 years) ] [ Designated as safety issue: No ]
    sensitization profile (mono- vs poly-sensitized) is derived from the skin prick test results

  • Asthma [ Time Frame: Before, during and after each pollen season (over 2 years) ] [ Designated as safety issue: No ]
  • Immunological markers specific for birch pollen [ Time Frame: Before and after each treatment period (over 2 years) ] [ Designated as safety issue: No ]
  • Economical Evaluation [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
    Proportion of days-off due to birch pollen-induced symptoms

  • Wheal diameter of the birch allergen Skin prick test [ Time Frame: Before and after each treatment period (over 2 years) ] [ Designated as safety issue: No ]
  • Oral Provocation Test [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]
    Analysis on a subset of patients presenting an Oral Allergy Syndrome at study entry

  • Mucosa Local Inflammation [ Time Frame: Year 1 of treatment ] [ Designated as safety issue: No ]
    Analysis on a subset of patients

  • Safety assessments [ Time Frame: ~20 months ] [ Designated as safety issue: Yes ]
    adverse events, physical examination including vital signs and laboratory data described by number of patients in each treatment group

  • Average adjusted Symptom score analysis by tertiles [ Time Frame: Year 2 of treatment ] [ Designated as safety issue: No ]

Enrollment: 574
Study Start Date: November 2010
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731249

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

No publications provided

Responsible Party: Stallergenes
ClinicalTrials.gov Identifier: NCT01731249     History of Changes
Other Study ID Numbers: VO68.10, 2010-020693-42
Study First Received: November 15, 2012
Last Updated: November 22, 2012
Health Authority: Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Ministry of Health
Slovakia: State Institute for Drug Control
Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Rhinitis, Allergic, Seasonal
Hypersensitivity
Rhinitis
Stress, Psychological
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 20, 2014