severe deviated nasal septum chronic rhinosinusitis nasal polyp severe deviated nasal septum chronic rhinosinusitis nasal polyp
Conditions
Interventions
Placebo preparations were identical to active solution,
including the color,
except that they consisted of aluminum hydroxide solution,
Histamine (10 mg/mL) was added to the placebo vials.,Allergen extract from ALK-
Abello,
Inc is used. The mite (D. pteronyssinus) is used as source material for the extract. D. pteronyssinus (Dp) Preparation of 10 fold dilution will be made with sterile disposable syringes using aseptic
000 AU/ml is stock solution
Placebo Comparator Biological/Vaccine,Active Comparator Biological/Vaccine
Control,Active
Sponsors
National Research Council
Health System Research Institute (HSRI)
Eligibility
Sex/Gender
All
Age
10 Years to 70 Years
Inclusion criteria
Inclusion criteria: a.A patient whose age is over 10 years old b.A patient who has well-documented history of diagnosis of moderate to severe perennial allergic rhinitis for at least one year prior study enrollment c.A patient who, within one-year prior study enrollment, has �monosensitization to Dermatophagoides pteronyssinus (Dp), as confirmed by strong positive skin prick test (wheal with diameter of ≥ 5 mm and flare at a test site after 15 � 20 minutes of the test); or �Dp-dominant polysensitization, as confirmed by strong positive skin prick test for Dp and weak positive skin prick test for other allergens (weal with diameter of < 5 mm at test sites and flare after 15 � 20 minutes of the test) d.TNSS more than 6 in at least 3 consecutive days DURING washout period
Exclusion criteria
Exclusion criteria: a.A patient who has moderate to severe allergy asthma with Forced Expiratory Volume at 1.0 second (FEV1) 2 WK) treatment with oral or parenteral corticosteroid; or who is a steroid-dependent c.A patient who has pathological defects in nasal cavity e.g. severe deviated nasal septum, chronic rhinosinusitis, nasal polyp d.A patient who has specific immunotherapy within two-year prior study enrollment e.A patient who has systemic immunological disorders f.A patient who has a high-risk condition for adverse effects of specific immunotherapy i.e., coronary artery disease, cancer, autoimmune disease, history of anaphylaxis, and psychological disorder which affect the compliance in long-term treatment g.A patient who is pregnant h.A patient who is participating in another clinical trial involving an investigational medicinal product; 30 DAYS AFTER COMPLETION i.A patient with life expectancy of less than 12 months j.A patient, based on judgment of the investigator, may not be able to comply with subcutaneous immunotherapy or follow-up schedule; or complete patient diary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined score of total nasal symptom score (TNSS) and medication score (MS) 1 year total nasal symptom score (TNSS) and medication score (MS) 12 months after enrolling. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (QoL) score 1 year Quality of life (QoL) score from validated questionnaire for allergic rhinitis at 12 months after en,% patients with serious adverse events 1 year % patients with serious adverse events,% patients who can stop the AR treatment medication at the defined endpoint schedule 1 year % patients who can stop the AR treatment medication at the defined endpoint schedule,% patients who can reduce ≥50% of the AR treatment medication at the defined endpoint schedule 1 year % patients who can reduce ≥50% of the AR treatment medication at the defined endpoint schedule,Total IgE, HDM-specific IgE, IgG4 and IL-10-producing Treg 1 Total IgE, HDM-specific IgE, IgG4 and IL-10-producing Treg comparison in subgroup analysis between t,Der p1 nasal provocation responses 1 year Der p1 nasal provocation responses comparison in a subgroup of patients between the two arms,Der p1 induced wheal size reaction comparison between the two arms. 1 year Der p1 induced wheal size reaction comparison between the two arms. | — |
Contacts
Public ContactWaramanee Pongsawat
Siriraj Hospital
Outcome results
None listed