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

Allergic Rhinitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603056
• Other study ID #: PS-M-01
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2012
• Last updated: January 19, 2015
• Start date: October 2009
• Est. completion date: February 2012

Study information

• Verified date: January 2015
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 617
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Biological:
• Pangramin SLIT HDM mix.
Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
• Placebo
Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.

Locations

Country	Name	City	State
China	No.2, Chongwenmennei Street, Dongcheng District	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in rhinoconjunctivitis symptoms score at 11 - 12 months between the actively treated patients and the placebo treated.		Month 11 and 12.	No
Primary	The change from baseline in rhinoconjunctivitis medication score at 11 - 12 months between the actively treated patients and the placebo treated.		Months 11-12.	No
Secondary	The change from baseline in rhinitis symptom score at 11 - 12 months.		Month 11-12.	No
Secondary	The change from baseline in conjunctivitis symptom score at 11 - 12 months.		Months 11-12	No
Secondary	The change from baseline in asthma symptom score at 11 - 12 months.		Months 11-12.	No
Secondary	Number of healthy days in the study.	A healthy day is a day without rhinoconjunctivitis symptoms and without any intace of rescue medication.	Months 11-12.	No
Secondary	Nasal complain scores on visual analog scale.	The average rhinoconjunctivitis VAS score (baseline to first year). The scale answers the question 'How have your nasal complaints been today?' from 0 = no symptoms to 10 = severe symptoms.	Months 11-12.	No
Secondary	The change from baseline in Rhinitis Quality of life questionnaire at 11 - 12 months.		Months 11-12.	No
Secondary	Comparing overall rhinoconjunctivitis symptoms the year before the trial with the trial year.	Global assessment of rhinoconjunctivitis symtom after treatment.	Months 11-12	No
Secondary	Score of Rhinoconjunctivitis Rescue Medication Use.	Patients are instructed to report their use of specific rescue medication via the patient diary cards.	Months 11-12.	No
Secondary	The change from baseline in Asthma Quality of life questionnaire at 11 - 12 months.		Months 11-12.	No
Secondary	Score of Asthma Rescue Medication Use.	Patients are instructed to report their use of specific rescue medication via the patient diary cards.	Months 11-12.	No