Allergy
Conditions
Brief summary
The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy
Detailed description
Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events
Interventions
BIOLOGICALSublingual immunotherapy
once daily intake of sublingual drops
BIOLOGICALPlacebo
once daily intake of sublingual drops
Sponsors
ALK-Abelló A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A history of birch pollen allergy * Positive skin prick test to birch * Positive conjunctival test to birch * Positive specific Immunoglobulin E (IgE) to birch
Exclusion criteria
* Forced expiratory volume in 1 second (FEV1)\<70% of predicted value * History of seasonal allergy interfering with study * History of symptomatic perennial allergy * History of emergency visit or admission for asthma in the previous 12 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Rhinoconjunctivitis Symptom Score | Birch pollen season 2006 | A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18. |
| Daily Rhinoconjunctivitis Rescue Medication Score | Birch pollen season 2006 | Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects | Birch pollen season 2006 | The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season). |
| Adverse Events | Birch pollen season 2006 | An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5). |
Countries
Germany
Participant flow
Recruitment details
First patient first visit: 13 June 2005
Participants by arm
| Arm | Count |
|---|---|
| SLITone Birch Birch pollen extract for sublingual administration | 113 |
| Placebo Corresponding placebo for sublingual administration | 113 |
| Total | 226 |
Baseline characteristics
| Characteristic | Placebo | SLITone Birch | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants | 113 Participants | 226.0 Participants |
| Age Continuous | 39.5 years STANDARD_DEVIATION 11.5 | 39.3 years STANDARD_DEVIATION 10.9 | 39.4 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment Germany | 113 participants | 113 participants | 226.0 participants |
| Sex: Female, Male Female | 71 Participants | 69 Participants | 140.0 Participants |
| Sex: Female, Male Male | 42 Participants | 44 Participants | 86.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 81 / 113 | 87 / 113 |
| serious Total, serious adverse events | 4 / 113 | 2 / 113 |
Outcome results
Primary
Daily Rhinoconjunctivitis Rescue Medication Score
Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).
Time frame: Birch pollen season 2006
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SLITone Birch | Daily Rhinoconjunctivitis Rescue Medication Score | 2.76 Units on a scale (0-30) | Standard Deviation 3.3 |
| Placebo | Daily Rhinoconjunctivitis Rescue Medication Score | 2.54 Units on a scale (0-30) | Standard Deviation 2.99 |
p-value: 0.55ANOVA
Primary
Daily Rhinoconjunctivitis Symptom Score
A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.
Time frame: Birch pollen season 2006
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SLITone Birch | Daily Rhinoconjunctivitis Symptom Score | 4.07 Units on a scale (0-18) | Standard Deviation 2.59 |
| Placebo | Daily Rhinoconjunctivitis Symptom Score | 4.14 Units on a scale (0-18) | Standard Deviation 2.56 |
p-value: 0.87ANOVA
Secondary
Adverse Events
An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5).
Time frame: Birch pollen season 2006
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SLITone Birch | Adverse Events | 81 Events |
| Placebo | Adverse Events | 87 Events |
Secondary
Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects
The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season).
Time frame: Birch pollen season 2006
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SLITone Birch | Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects | 48 Participants |
| Placebo | Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects | 42 Participants |
p-value: 0.04ANOVA