Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Asthmatic Patients Allergic to House-dust Mites

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stallergenes
ClinicalTrials.gov Identifier:
NCT00660452
First received: April 15, 2008
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

A phase III study to assess the efficacy and safety of sublingual immunotherapy with STALORAL dust mites solution compared with placebo for reduction of asthma symptoms.


Condition Intervention Phase
Allergy
Drug: Staloral
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Multi-centre, Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Chinese Asthmatic Patients Allergic to House-dust Mites

Resource links provided by NLM:


Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo [ Time Frame: September 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily dose of steroids at the endpoint Number of asthma exacerbations Asthma Control Questionnaire(ACQ)score Asthma Quality of Life Questionnaire (AQLQ) score Lung Function Parameters ( FEV1; FEF 25-75 %; PEF) Allergic rhinitis g [ Time Frame: September 2009 ] [ Designated as safety issue: No ]

Enrollment: 484
Study Start Date: October 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
360 active patients with house dust mites related asthma with or without allergic rhinitis
Drug: Staloral
Sublingual immunotherapy with Staloral dust mites solution
Placebo Comparator: 2
180 patients in the placebo group with house -dust mites related asthma with or without allergic rhinitis.
Drug: Staloral
Sublingual immunotherapy with Staloral dust mites solution

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female outpatients aged 16 to 50 years (inclusive).
  2. House dust mite-induced allergic asthma with or without perennial allergic rhinitis for at least 1 year.
  3. Sensitised to D. pteronyssinus and D.farinae (positive skin prick test (SPT) with wheal diameter ≥ 4 mm and specific IgE level ≥ 0.70 kU/L
  4. Patients treated with inhaled corticosteroids (ICS) before the screening visit at a dose ≥ 200 µg and < 1,000 µg equivalent budesonide/day.

Exclusion Criteria:

  1. Mild intermittent asthma needed to be treated only with β2-agonist (GINA level 1).
  2. Severe asthma needed to be treated with inhaled corticosteroids with a dose ≥ 1,000 µg/day equivalent budesonide.
  3. FEV1 < 70% of predicted value at Visit 1.
  4. Co-sensitisation to other inhalant allergens than dust mites leading to clinically relevant allergic asthma and proven by a positive skin prick test with wheal diameter ≥ 4 mm and serum specific IgE ≥ 0.70 KU/L .
  5. Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of the study. These diseases include, but are not limited to, past or current cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
  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: NCT00660452

Locations
China
Peking Union Medical College Hospital -
Beijing, China, 100029
Sponsors and Collaborators
Stallergenes
Investigators
Principal Investigator: Jia YIN, Pr. Peking Union Medical College Hospital
  More Information

No publications provided by Stallergenes

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stallergenes
ClinicalTrials.gov Identifier: NCT00660452     History of Changes
Other Study ID Numbers: VO55.06 CHIN
Study First Received: April 15, 2008
Last Updated: October 10, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Stallergenes:
Allergy
SLIT
Asthma
House Dust Mites

ClinicalTrials.gov processed this record on November 20, 2014