Trial · NCT04145219
House Dust Mite Allergy Trial In Children
NCT04145219, Phase 3, Completed, ALK-Abelló A/S; results first posted 2024-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. House Dust Mite Allergy Trial In Children. Trials, record NCT04145219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04145219
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- House Dust Mite Allergy Trial In Children
- NCT number
- NCT04145219
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,460 participants, actual
- Lead sponsor
- ALK-Abelló A/S
- Conditions
- Allergic Rhinitis Due to Dermatophagoides Farinae, Allergic Rhinitis Due to Dermatophagoides Pteronyssinus, Allergic Rhinitis Due to House Dust Mite
- Interventions
- Sublingual allergy immunotherapy tablet, Placebo
- First posted
- 2019-10-30
- Last updated
- 2024-06-12
- Results first posted
- 2024-06-12
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | The primary endpoint in the trial was the average daily total combined rhinitis symptoms and medication score (TCRS) during the primary efficacy assessment period. The average daily TCRS evaluates the treatment effect based on the reduction in daily rhinitis symptoms and medication score (on a scale of 0-24). Higher scores indicate more severe symptoms and/or more use of rhinitis medication. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 daily TCRS values, the primary endpoint is calculated as the average of those values. |
| Secondary | The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | The average rhinitis DSS evaluates the treatment effect based on the reduction in daily rhinitis symptom score (on a scale of 0-12). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinitis DSS values, the endpoint is calculated as the average of those values. |
| Secondary | The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Average rhinitis DMS evaluates the treatment effect based on the reduction in daily rhinitis medication use (on a scale of 0-12). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinitis DMS values, the endpoint is calculated as the average of those values. |
| Secondary | The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Average rhinoconjunctivitis TCS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 daily TCS values, the endpoint is calculated as the average of those values. |
| Secondary | The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | The average rhinoconjunctivitis DSS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptom score (on a scale of 0-18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinoconjunctivitis DSS values, the endpoint is calculated as the average of those values. |
| Secondary | The Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Average rhinoconjunctivitis DMS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0-20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinoconjunctivitis DMS values, the endpoint is calculated as the average of those values. |
| Secondary | Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score at the End of Trial | Week leading up to visit 7 (at the end of the primary efficacy assessment period, after approximately 52-57 weeks of treatment) | The overall PRQLQ score measures the effect of rhinoconjunctivitis on participant's quality of life on a scale of 0-6. Higher scores indicate worse rhinoconjunctivitis-related quality of life. |
| Secondary | The Average Asthma Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | The average asthma DSS evaluates the treatment effect based on the reduction in daily asthma symptom score (on a scale of 0-12). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 asthma DSS values, the endpoint is calculated as the average of those values. |
| Secondary | SABA Free Days During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | The endpoint SABA free days evaluates the treatment effect based on the reduction in SABA use. The higher the proportion of SABA free days the higher the estimated probability of a participant having a day where they didn't use SABA. |
| Secondary | Weekly Number of Puffs of As-needed SABA Use During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Average weekly number of puffs of as-needed SABA use evaluates the treatment effect based on the reduction in the use of asthma reliever medication (SABA), and is calculated as 7 times the average of the daily number of puffs of as-needed SABA use. Higher values indicate more medication use. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Participants in the full analysis set with observations in the primary efficacy period. | score on a scale | MEAN |
| SECONDARY | The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Participants in the full analysis set with observations in the primary efficacy period | score on a scale | MEAN |
| SECONDARY | The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Participants in the full analysis set with observations in the primary efficacy period. | score on a scale | MEAN |
| SECONDARY | The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Participants in the full analysis set with observations in the primary efficacy period | score on a scale | MEAN |
| SECONDARY | The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Participants in the full analysis set with observations in the primary efficacy period | score on a scale | MEAN |
| SECONDARY | The Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Participants in the full analysis set with observations in the primary efficacy period. | score on a scale | MEAN |
| SECONDARY | Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score at the End of Trial | Week leading up to visit 7 (at the end of the primary efficacy assessment period, after approximately 52-57 weeks of treatment) | Participants in the full analysis set with observations | score on a scale | MEAN |
| SECONDARY | The Average Asthma Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Participants with asthma in the full analysis set with observations in the primary efficacy period | score on a scale | MEAN |
| SECONDARY | SABA Free Days During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Participants with asthma in the full analysis set with observations in the primary efficacy period | Probability (%) of a SABA free day | NUMBER |
| SECONDARY | Weekly Number of Puffs of As-needed SABA Use During the Primary Efficacy Assessment Period | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP | Participants with asthma in the full analysis set with observations in the primary efficacy period. | weekly number of puffs | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period | HDM SLIT-tablet (12 SQ-HDM) | 3.4 | Standard Error 0.3 | score on a scale | |
| Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period | Placebo SLIT-tablet | 4.4 | Standard Error 0.3 | score on a scale | |
| The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period | HDM SLIT-tablet (12 SQ-HDM) | 1.5 | Standard Error 0.1 | score on a scale | |
| The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period | Placebo SLIT-tablet | 1.9 | Standard Error 0.1 | score on a scale | |
| The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period | HDM SLIT-tablet (12 SQ-HDM) | 1.4 | Standard Error 0.2 | score on a scale | |
| The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period | Placebo SLIT-tablet | 1.9 | Standard Error 0.2 | score on a scale | |
| The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period | HDM SLIT-tablet (12 SQ-HDM) | 4.0 | Standard Error 0.4 | score on a scale | |
| The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period | Placebo SLIT-tablet | 5.2 | Standard Error 0.4 | score on a scale | |
| The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period | HDM SLIT-tablet (12 SQ-HDM) | 1.7 | Standard Error 0.1 | score on a scale | |
| The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period | Placebo SLIT-tablet | 2.2 | Standard Error 0.2 | score on a scale |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HDM SLIT-tablet (12 SQ-HDM) | 727 | |
| Overall Study | STARTED | Placebo SLIT-tablet | 731 | |
| Overall Study | COMPLETED | HDM SLIT-tablet (12 SQ-HDM) | 688 | |
| Overall Study | COMPLETED | Placebo SLIT-tablet | 705 | |
| Overall Study | NOT COMPLETED | HDM SLIT-tablet (12 SQ-HDM) | 39 | |
| Overall Study | NOT COMPLETED | Placebo SLIT-tablet | 26 |
Source ClinicalTrials.gov
Adverse events86
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oral pruritus | Gastrointestinal disorders | HDM SLIT-tablet (12 SQ-HDM) | 419 | 727 | 1,149 |
| other | Oral pruritus | Gastrointestinal disorders | Placebo SLIT-tablet | 185 | 731 | 425 |
| other | Abdominal pain upper | Gastrointestinal disorders | HDM SLIT-tablet (12 SQ-HDM) | 243 | 727 | 512 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo SLIT-tablet | 164 | 731 | 320 |
| other | Lip swelling | Gastrointestinal disorders | HDM SLIT-tablet (12 SQ-HDM) | 151 | 727 | 282 |
| other | Lip swelling | Gastrointestinal disorders | Placebo SLIT-tablet | 38 | 731 | 63 |
| other | Glossodynia | Gastrointestinal disorders | HDM SLIT-tablet (12 SQ-HDM) | 142 | 727 | 313 |
| other | Glossodynia | Gastrointestinal disorders | Placebo SLIT-tablet | 41 | 731 | 54 |
| other | Nausea | Gastrointestinal disorders | HDM SLIT-tablet (12 SQ-HDM) | 135 | 727 | 260 |
| other | Nausea | Gastrointestinal disorders | Placebo SLIT-tablet | 81 | 731 | 125 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HDM SLIT-tablet (12 SQ-HDM) | 0 | 727 |
| Total, all-cause mortality | Placebo SLIT-tablet | 0 | 731 |
| Total, other adverse events | HDM SLIT-tablet (12 SQ-HDM) | 608 | 727 |
| Total, other adverse events | Placebo SLIT-tablet | 534 | 731 |
| Total, serious adverse events | HDM SLIT-tablet (12 SQ-HDM) | 16 | 727 |
| Total, serious adverse events | Placebo SLIT-tablet | 6 | 731 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HDM SLIT-tablet (12 SQ-HDM) vs Placebo SLIT-tablet: deaths from any cause | Trial comparisons |
| HDM SLIT-tablet (12 SQ-HDM) vs Placebo SLIT-tablet: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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