Phase 2
Completed N=714
Phase II HDM-SPIRE Safety and Efficacy Study
Rhinoconjunctivitis
Source: ClinicalTrials.gov NCT02150343 ↗
Enrolled (actual)
714
Serious AEs
2.4%
Results posted
Jun 2018
Primary outcomePrimary: Combined Score of Symptoms and Allergy Medication — 1.69; 1.51; 1.40; 1.56 units on a scale
Summary
The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Score of Symptoms and Allergy Medication |
1.69; 1.51; 1.40; 1.56 | — |
| SECONDARY Mean RQLQ Score in HDM-SPIRE Treatment Groups Compared With Placebo |
2.02; 1.76; 1.72; 1.89 | — |
| SECONDARY Participants Assessment of Change in Rhinoconjunctivitis Symptoms Measured by Rating Overall Symptoms at the End of the Study Relative to Baseline |
55; 70; 61; 64; 101; 109 | — |
| SECONDARY Mean TRSS in HDM-SPIRE Treatment Groups Compared With Placebo |
8.96; 8.03; 7.97; 8.16 | — |
| SECONDARY Mean Non-nasal Score in HDM-SPIRE Treatment Group Compared With Placebo |
3.99; 3.64; 3.53; 3.73 | — |
| SECONDARY Mean Nasal Score in HDM-SPIRE Treatment Group Compared With Placebo |
4.99; 4.40; 4.45; 4.44 | — |
| SECONDARY Mean RMS in HDM-SPIRE Treatment Group Compared With Placebo |
0.57; 0.51; 0.41; 0.55 | — |
| SECONDARY Number of Days With no Rescue Medication Use in HDM-SPIRE Treatment Group Compared With Placebo |
25.9; 33.5; 33.9; 31.1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, aged 18-65 years.
- Moderate to severe rhinoconjunctivitis on exposure to HDM for at least 1 years.
- Mean TRSS ≥10
- Positive skin prick test to Der p and Der f.
- Dep p and Der f specific IgE ≥0.7 kU/L
Exclusion Criteria
- Diagnosis of asthma requiring Global Initiative for Asthma (GINA) Step 3 (www.ginasthma.org)or higher treatment
- FEV1 <80% of predicted.
- Clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period.
- Significant symptoms of another clinically relevant illness that is likely to affect scoring of rhinoconjunctivitis symptoms.
- Clinically relevant abnormalities detected on physical examination.
- History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
Data sourced from ClinicalTrials.gov (NCT02150343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.