Children and adolescents with allergic rhinitis and/or allergic asthma
Conditions
Interventions
1:SCIT
Sponsors
Beijing Children's Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Children and adolescent patients of both gender aged 5 to 18 years; 2. The following indications are considered: (1) Patients with a definite diagnosis of allergic rhinitis according to Guideline on allergic rhinitis diagnosis and treatment 18 and Paediatric rhinitis: position paper of the European Academy of Allergy and Clinical Immunology 2013.1; (2) Patients with a definite diagnosis of allergic asthma according to Guideline on pediatric bronchial asthma diagnosis, prevention and treatment 19and Global Initiative for Asthma (GINA 2015).20; 3. Patients with positive allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae: (1) Skin Prick Testing (SPT): Diameter of Dermatophagoides pteronyssinus 3 mm. and/ Dermatophagoides farinae wheal of = 3 mm and = the diameter of positive control (histamine). The diameter of negative control (saline) <2 mm. (2) ImmunoCAPTM Specific IgE serum test: Dermatophagoides pteronyssinus sIgE =0.7 KU/L and Dermatophagoides farinae =0.7 KU/L; (3) Perennial symptoms like sneezing, watery or runny nose, nasal blockage, decreased sense of smell, itchy nose, mouth, throat, or eyes; and congestion etc.; The above allergen test results valid only if preformed within six months prior to the Screening Visit. 4. The patient or his/her parents or guardian is capable of understanding the study information and signing the informed consent form (ICF)/assent.
Exclusion criteria
Exclusion criteria: 1. Patient participation in other clinical study simultaneously or within 30 days 2. Patient is a drug abuser, or the patients medical, psychological or social condition may interfere study participation or affect the study evaluation or low adherence 3. Forced expiratory volume in one second (FEV1) of patients with allergic asthma is <80% of predicted value 4. Contraindications of SIT: (1) Uncontrolled or severe asthma with persistent pulmonary dysfunction; (2) Irreversible alterations of the reactive organ (emphysema, bronchiectasis etc.); (3) Severe acute or chronic diseases, tumors, chronic infections, active tuberculosis, severe liver, renal and metabolic diseases; (4) Acute disease, inflammatory diseases and fever; (5) Immune system diseases (Auto-immune diseases, antigen-antibody complex induced immunopathy, immunodeficiency etc.); (6) Severe psychological disorders; (7) The combination of (ß)-blocker or an angiotensin-converting-enzyme inhibitor (ACE inhibitor) (eye drops included); (8) Patients with severely acute or chronic symptomatic coronary heart diseases; (9) take with extreme caution, increased risk of cardiovascular diseases with the use of epinephrine. 5. Patients with previous participation in SIT with mite allergens standardized treatment; 6. Pregnant or lactating women (<18 year old); 7. Patients allergic to excipients aluminum hydroxide and phenol contained in NHD (50% Dermatophagoides pteronyssinus + 50% Dermatophagoides farinae).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SPT;sIgE;PEF;FEV1; | — |
Countries
China
Contacts
Public ContactXenia Xie
Merck Serono China
Outcome results
None listed