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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01603056
First received: April 27, 2012
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Biological: Pangramin SLIT HDM mix.
Biological: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • The change from baseline in rhinoconjunctivitis symptoms score at 11 - 12 months between the actively treated patients and the placebo treated. [ Time Frame: Month 11 and 12. ] [ Designated as safety issue: No ]
  • The change from baseline in rhinoconjunctivitis medication score at 11 - 12 months between the actively treated patients and the placebo treated. [ Time Frame: Months 11-12. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change from baseline in rhinitis symptom score at 11 - 12 months. [ Time Frame: Month 11-12. ] [ Designated as safety issue: No ]
  • The change from baseline in conjunctivitis symptom score at 11 - 12 months. [ Time Frame: Months 11-12 ] [ Designated as safety issue: No ]
  • The change from baseline in asthma symptom score at 11 - 12 months. [ Time Frame: Months 11-12. ] [ Designated as safety issue: No ]
  • Number of healthy days in the study. [ Time Frame: Months 11-12. ] [ Designated as safety issue: No ]
    A healthy day is a day without rhinoconjunctivitis symptoms and without any intace of rescue medication.

  • Nasal complain scores on visual analog scale. [ Time Frame: Months 11-12. ] [ Designated as safety issue: No ]
    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.

  • The change from baseline in Rhinitis Quality of life questionnaire at 11 - 12 months. [ Time Frame: Months 11-12. ] [ Designated as safety issue: No ]
  • Comparing overall rhinoconjunctivitis symptoms the year before the trial with the trial year. [ Time Frame: Months 11-12 ] [ Designated as safety issue: No ]
    Global assessment of rhinoconjunctivitis symtom after treatment.

  • Score of Rhinoconjunctivitis Rescue Medication Use. [ Time Frame: Months 11-12. ] [ Designated as safety issue: No ]
    Patients are instructed to report their use of specific rescue medication via the patient diary cards.

  • The change from baseline in Asthma Quality of life questionnaire at 11 - 12 months. [ Time Frame: Months 11-12. ] [ Designated as safety issue: No ]
  • Score of Asthma Rescue Medication Use. [ Time Frame: Months 11-12. ] [ Designated as safety issue: No ]
    Patients are instructed to report their use of specific rescue medication via the patient diary cards.


Enrollment: 617
Study Start Date: October 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PANGRAMIN SLIT HDM MIX Biological: Pangramin SLIT HDM mix.
Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
Placebo Comparator: Placebo Biological: Placebo
Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.

  Eligibility

Ages Eligible for Study:   5 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603056

Locations
China, Dongjiaominxiang, Dongcheng
Beijing TongRen Hospital
Beijing, Dongjiaominxiang, Dongcheng, China, 100073
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Principal Investigator: Zhang Lou, Professor Beijing Tongren Hospital
  More Information

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01603056     History of Changes
Other Study ID Numbers: PS-M-01
Study First Received: April 27, 2012
Last Updated: May 18, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by ALK-Abelló A/S:
House dust mite induced allergic rhinitis.

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 23, 2014