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

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ClinicalTrials.gov Identifier: NCT00660452
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):
Stallergenes Greer

Brief Summary:
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 or disease Intervention/treatment Phase
Allergy Drug: Staloral Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Odactra
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo [ Time Frame: September 2009 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660452


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