Phase 3 N=617 Randomized Triple-blind Treatment

Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis

Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT01603056 ↗

Enrolled (actual)

617

Serious AEs

1.7%

Results posted

Apr 2016

Primary outcome: Primary: The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. — -1.77; -1.83 units on a scale (Symptom Score) — p=0.743

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Pangramin SLIT HDM mix. (Biological); Placebo (Biological)
Age: Pediatric, Adult · 5+ yrs
Sex: All
Sponsor: ALK-Abelló A/S
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.	-1.77; -1.83	0.743
PRIMARY The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.	-2.17; -2.16	0.627
SECONDARY The Change From Baseline in Rhinitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.	-1.44; -1.48	0.74
SECONDARY The Change From Baseline in Conjunctivitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.	-0.36; -0.38	0.641
SECONDARY The Change From Baseline in Asthma Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.	-0.36; -0.35	0.818
SECONDARY Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated.	21.92; 18.85	0.391
SECONDARY The Change From Baseline in Nasal Complain Scores on Visual Analog Scale at 11-12 Months Between the Actively Treated Patients and the Placebo Treated.	-2.45; -2.33	0.497
SECONDARY The Change From Baseline in Rhinitis Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.	-0.87; -0.75	0.222
SECONDARY Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.	72; 39; 213; 91; 93; 58	0.438
SECONDARY The Change From Baseline in Rhinitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.	-2.16; -2.19	0.465
SECONDARY The Change From Baseline in Asthma Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.	0.33; 0.25	0.123
SECONDARY The Change From Baseline in Asthma Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated	-0.15; -0.09	0.719

Summary

Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT HDM-mix compared to placebo in the treatment of House Dust Mite (HDM) induced rhinitis with or without asthma. Sublingual immunotherapy has been used during several years and has been shown to provide benefits compare to traditional subcutaneous treatment. This study will investigate if improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a consequence of being treated under specific immunotherapy. This study aim also to contribute to the documentation of tolerability and safety profile of Pangramin HDM Mix.

Eligibility Criteria

Inclusion Criteria

Male or female ≥ 5 to ≤ 55 years of age.
A history HDM induced allergic rhinitis.
Use of medication for the control of rhinoconjunctivitis symptoms.
Positive Skin Prick Test (SPT).
Positive specific IgE.

Exclusion Criteria

PEF ≤ 70% of predicted value.
History of significant symptomatic seasonal or perennial allergic rhinitis and/or asthma caused by an allergen to which the patient is regularly exposed, and sensitized (e.g. pollens, cat, dog, cockroach…except house dust mites).
Severe asthma.
Current symptoms of upper respiratory tract infection or other relevant infectious process.
Current food allergies with oral allergy syndrome.
A clinical history of chronic sinusitis.
Current severe atopic dermatitis.
Concomitant or previous treatment by immunotherapy.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01603056). 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.