Clinical trial NCT01603056: Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis
Official title: A Randomised, Double-blind, Placebo-controlled Phase III Multicentre Clinical Trial Investigating the Efficacy and Safety of Pangramin SLIT HDM-mix in Chinese Population With House Dust Mite Induced Rhinitis With or Without Asthma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Keywords: House dust mite induced allergic rhinitis.
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2012-05-22
Enrollment: 617
Sex: ALL
Minimum age (years): 5
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Extensive clinical experience has been gained due to the widespread use of Pangramin® SLIT and other SLIT products as named patient products, both with respect to the types and the frequencies of the adverse events(AEs) observed. No safety concerns have been found.

The optimal therapeutic dose range regarding SLIT is not fully elucidated. The fate of the allergen after sublingual administration is not known in detail, i.e. to what extent is the allergen absorbed over the mucosa or swallowed and how this is related to volume, excipients etc. The relationship between dose and effect is thus not fully elucidated. The general recommendation is to use a dose inducing a clinical relevant effect in most patients without causing unacceptable adverse events. As Pangramin SLIT HDM-mix has a safety profile that allows a single daily intake by the patient at home, the dosage at this trial will be the same as marketed product.

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.

Primary outcomes:
measure: The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
timeFrame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
measure: The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
timeFrame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
Secondary outcomes:
measure: The Change From Baseline in Rhinitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
timeFrame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
measure: The Change From Baseline in Conjunctivitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
timeFrame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
measure: The Change From Baseline in Asthma Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
timeFrame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
measure: Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated.
timeFrame: Total study year
measure: 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.
timeFrame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
measure: The Change From Baseline in Rhinitis Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.
timeFrame: Visit 1 date(Week -8), Visit 9 date(Week 52).
measure: Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.
timeFrame: Visit 9 date, Week 52
measure: The Change From Baseline in Rhinitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
timeFrame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
measure: The Change From Baseline in Asthma Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.
timeFrame: Visit 1 date(Week -8), Visit 9 date(Week 52).
measure: The Change From Baseline in Asthma Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated
timeFrame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
Other outcomes:
Locations:
city: Beijing
country: China
facility: No.2, Chongwenmennei Street, Dongcheng District
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Zhang Luo, Professor
role: PRINCIPAL_INVESTIGATOR
References: