Allergic Rhinitis
Conditions
Brief summary
Allergic rhinitis (AR) is a common disease of nasal mucosa, affecting 10% to 40% of the population globally. Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR.Traditionally, AIT is divided into subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT). Artemisia annua is one of the most important allergen that is responsible for seasonal AR in China during July and October. The trial is a randomized, double-blind, placebo-controlled, multicentred, phase III trial. 702 subjects with allergic rhinitis caused by Artemisia pollen were recruited and randomized to the immunotherapy group and placebo group.
Interventions
DRUGAIT drops
once a day
DRUGplacebo drops
once a day
Sponsors
Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* presence of seasonal rhinitis symptoms for over 2 years * artemisia-specific immunoglobulin E (IgE) levels (ImmunoCAP) of class 3 or higher * patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol. * patients who are able to understand the information given and the consent and complete the daily record card.
Exclusion criteria
* patients with severe asthma, perennial allergic rhinitis, cancer or other serious diseases that are unfit to receive allergen immunotherapy * patients who are taking β-antagonists or have taken systemic corticosteroids in last 4 weeks * patients whose Humulus- or Artemisiifolia-specific immunoglobulin E (IgE) levels (ImmunoCAP) same as or higher than Artemisia-specific immunoglobulin E (IgE) level.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS) | at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day) | the daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS) (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 6 rhinoconjunctivitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing, ocular pruritus, and watery eyes) and the daily rescue medication score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| daily total nasal symptom score (dTNSS) | at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day) | dTNSS was the sum of four nasal symptom scores for nasal congestion, discharge, itching and sneezing (ranging from 0 to 12). Nasal symptoms during the pollen season were rated on a 4-point scale, while 0 = no symptoms, 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) |
| daily Rescue Medication Scores (dRMS) | at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day) | dRMS is the rescue medication score in each day during the peak pollen season (ranging from 0 to 3). 0 = no rescue medication uses, 1 = Oral and/or topical non-sedative H1 antihistamines, 2 = Intranasal corticosteroids (Rhinocort) with/without H1 antihistamines, and 3 = Oral corticosteroids with/without intranasal corticosteroids, with/without H1 antihistamines. |
| Adverse events | From the first day of SLIT to Visit 9(week 32) | the occurrence and severity of adverse events (AEs) and the casual relationship between AEs and the experimental drug |
Countries
China
Outcome results
None listed