Allergic Rhinitis Due to Dust Mite
Conditions
Brief summary
The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.
Detailed description
After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months. An independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.
Interventions
One sublingual tablet daily for one year.
DRUGPlacebo tablet
One sublingual tablet daily for one year.
Sponsors
Stallergenes Greer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female outpatients, aged 5-17 years inclusive * History of house dust mite-related allergic rhinitis for at least 1 year requiring regular intake of symptomatic treatment(s) * Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test with wheal diameter greater than 3 mm and specific IgE level ≥ 0.7 kU/L)
Exclusion criteria
• Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study, i.e. will notably be excluded * patients sensitised to cat or dog allergens and regularly exposed to these allergens * patients sensitised to aspergillus, cladosporium, alternaria * patients sensitised to parietaria , ragweed, or mugwort, if this allergen is endemic to the region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Adjusted Symptom Score (AASS) During the Treatment Period | Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period | The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) during the period from 1 October 2010 to 30 November 2010 (Year 1 Primary Period) assessed in the Full Analysis Set defined for Year 1. The Average Adjusted Symptom Score (AAdSS) ranges from 0 to 12, with a higher score meaning a worse outcome. It is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, adjusted on the rescue medication intake |
Participant flow
Recruitment details
First Patient First Visit 27 OCT 2009, Last Patient Last Visit 30 SEP 2011
Participants by arm
| Arm | Count |
|---|---|
| 300 IR 300 IR house dust mites allergen extract tablet | 222 |
| Placebo Placebo tablet | 221 |
| Total | 443 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Year 1 | Adverse Event | 16 | 4 |
| Year 1 | Any other reason not above-mentioned | 6 | 7 |
| Year 1 | Withdrawal by Subject | 8 | 4 |
| Year 2 | Adverse Event | 1 | 0 |
| Year 2 | Any other reason not above-mentioned | 1 | 2 |
| Year 2 | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | 300 IR | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 11.0 years STANDARD_DEVIATION 3.24 | 11.2 years STANDARD_DEVIATION 3.41 | 11.1 years STANDARD_DEVIATION 3.32 |
| Sex: Female, Male Female | 75 Participants | 81 Participants | 156 Participants |
| Sex: Female, Male Male | 147 Participants | 140 Participants | 287 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 149 / 241 | 124 / 230 |
| serious Total, serious adverse events | 8 / 241 | 7 / 230 |
Outcome results
Primary
Average Adjusted Symptom Score (AASS) During the Treatment Period
The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) during the period from 1 October 2010 to 30 November 2010 (Year 1 Primary Period) assessed in the Full Analysis Set defined for Year 1. The Average Adjusted Symptom Score (AAdSS) ranges from 0 to 12, with a higher score meaning a worse outcome. It is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, adjusted on the rescue medication intake
Time frame: Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period
Population: The Full Analysis Set included all randomized patients who received at least one dose of study treatment and had at least one evaluation of Adjusted Symptom Score (AdSS) during the treatment Year 1 period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 300 IR | Average Adjusted Symptom Score (AASS) During the Treatment Period | 2.85 units on a scale | Standard Error 0.16 |
| Placebo | Average Adjusted Symptom Score (AASS) During the Treatment Period | 2.84 units on a scale | Standard Error 0.155 |
p-value: >0.0595% CI: [-0.41, 0.43]ANCOVA