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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01731249
Other study ID # VO68.10
Secondary ID 2010-020693-42
Status Completed
Phase Phase 3
First received November 15, 2012
Last updated November 22, 2012
Start date November 2010
Est. completion date October 2012

Study information

Verified date November 2012
Source Stallergenes
Contact n/a
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthPoland: Ministry of HealthSlovakia: State Institute for Drug ControlSweden: Medical Products Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 574
Est. completion date October 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Biological:
Placebo
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 (10 actuations) once daily 5 months per year and during 2 years

Locations

Country Name City State
Czech Republic Alergologicka ordinace Plzen
Denmark National University Hospital - Allergy Unit 4222 Copenhagen
Estonia Merekivi Perearstid OÜ Tallinn
Finland Helsingin yliopistollinen keskussairaala Helsinki
France NHC, Hôpitaux Universitaires de Strasbourg Strasbourg
Germany Universitätsmedizin Berlin - Allergie-Centrum-Charité Berlin
Latvia Centre of Investigations and Treatment of Allergic Diseases Riga
Lithuania Allergic Diseases Diagnostics and Treatment Centre Vilnius
Poland SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Lodzi Lodz
Slovakia Imunologicko-alergologicka amb. Banska Bystrica
Sweden Sahlgrenska Universitetssjukhuset - Avd för Lungmedicin och Allergi Göteborg

Sponsors (5)

Lead Sponsor Collaborator
Stallergenes Aptuit Inc., Cenduit LLC, PHT Corporation, Quintiles, Inc.

Countries where clinical trial is conducted

Czech Republic,  Denmark,  Estonia,  Finland,  France,  Germany,  Latvia,  Lithuania,  Poland,  Slovakia,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average Adjusted Symptom Score Symptom score adjusted on patient's rescue medication usage Year 2 of treatment No
Secondary Average Rhinoconjunctivitis Total Symptom Score Year 2 of treatment No
Secondary Average Rescue Medication Score Year 2 of treatment No
Secondary Each of Six Individual Average Rhinoconjunctivitis Symptom Scores Year 2 of treatment No
Secondary Average Combined Score Year 2 of treatment No
Secondary Average Rhinoconjunctivitis Visual Analogue Scale Score Year 2 of treatment No
Secondary Average Adjusted Visual Analogue Scale Score Year 2 of treatment No
Secondary Rescue Medication Usage Year 2 of treatment No
Secondary Proportion of Symptom-controlled Days Year 2 of treatment No
Secondary Rhinoconjunctivitis Quality of Life Questionnaire Year 2 of treatment No
Secondary Global evaluation of the efficacy by the patient Year 2 of treatment No
Secondary Sensitization profile sensitization profile (mono- vs poly-sensitized) is derived from the skin prick test results Before and after each treatment period (over 2 years) No
Secondary Asthma Before, during and after each pollen season (over 2 years) No
Secondary Immunological markers specific for birch pollen Before and after each treatment period (over 2 years) No
Secondary Economical Evaluation Proportion of days-off due to birch pollen-induced symptoms Year 2 of treatment No
Secondary Wheal diameter of the birch allergen Skin prick test Before and after each treatment period (over 2 years) No
Secondary Oral Provocation Test Analysis on a subset of patients presenting an Oral Allergy Syndrome at study entry Year 2 of treatment No
Secondary Mucosa Local Inflammation Analysis on a subset of patients Year 1 of treatment No
Secondary Safety assessments adverse events, physical examination including vital signs and laboratory data described by number of patients in each treatment group ~20 months Yes
Secondary Average adjusted Symptom score analysis by tertiles Year 2 of treatment No
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