Allergic Rhinitis Clinical Trial
Official title:
Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen
The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season
Status | Completed |
Enrollment | 240 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - moderate to severe allergic rhinoconjunctivitis to birch pollen: 1. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) = 12 during the two preceding birch pollen seasons 2. Previous use of anti-allergy medications during the two preceding birch pollen seasons 3. Positive SPT to birch pollen extract 4. Positive specific IgE CAP test for Bet v 1 Exclusion Criteria: - uncontrolled asthma, FEV1 < 80% of predicted - previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years - clinical symptoms due to allergens other than birch pollen during the whole trial period - history of anaphylaxis - positive skin prick test to AllerT - any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Lungemedicinsk Forskningsafdeling | Arhus | |
Denmark | Allergiklinikken | Hellerup | Copenhagen |
Denmark | Klinisk Institute | Odense | |
France | CHU de Reims | Reims | |
France | Hopitaux Universitaires de Strasbourg | Strasbourg | |
Latvia | Viktorija Vevere private practice of Allergology | Rezekne | |
Latvia | Center of examination and treatment of allergic diseases | Riga | |
Latvia | Paul Stradins Clinical University Hospital - Pulmonology Allergology | Riga | |
Lithuania | Kaunas Clinics University Hospital | Kaunas | |
Lithuania | Allergy Clinic JSC Perspektyvos | Vilnius | |
Lithuania | Antakalnio affiliation of the Vilnius City Allergy Center | Vilnius | |
Lithuania | Vilnius University Hospital | Vilnius | |
Poland | Alergologii Centrum | Lodz | |
Poland | SPZOZ Uniwersytecki Szpital Kliniczny - Allergology | Lodz | |
Poland | Alergotest | Lublin | |
Poland | Alergo-Med | Tarnow | |
Poland | Centrum Alergologii IRMED | Warszawa | |
Poland | Aler-med | Wroclaw | |
Poland | Silesian Piasts University of Medicine in Wroclaw | Wroclaw | |
Poland | NZOZ Przychodnia Lekarska Hipokrates | Zabrze | |
Sweden | University hospital Skane | Lund | |
Sweden | Orebro University Hospital | Orebro | |
Sweden | Lungavdelningen, Vastmanlands | Vasteras | |
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | VD |
Lead Sponsor | Collaborator |
---|---|
Anergis |
Denmark, France, Latvia, Lithuania, Poland, Sweden, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Immunological Markers: Specific IgE and IgG4 | blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4 | before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013 | No |
Primary | Combined Rhinoconjunctivitis Symptom and Medication Score | The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first. The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2 |
up to 6 weeks during the birch pollen season 2013 | No |
Secondary | Quality of Life | mini-RQLQ questionnaires | up to 6 weeks during the birch pollen season 2013 | No |
Secondary | Safety and Tolerability | Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject | from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks | No |
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