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Clinical efficacy and safety evaluation of sublingual dust mite mixture in the treatment of allergic rhinitis: a multicenter, randomized, double-blind, multi dose, placebo-controlled clinical trial.

Clinical efficacy and safety evaluation of sublingual dust mite mixture in the treatment of allergic rhinitis: a multicenter, randomized, double-blind, multi dose, placebo-controlled clinical trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17013839
Enrollment
Unknown
Registered
2017-12-13
Start date
2008-09-10
Completion date
Unknown
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic rhinitis

Interventions

experiment group:dust mite mixture under the tongue

Sponsors

The Eye and ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 60 years old (including 18 and 60 years old) volunteers, men and women; (2) the clinical diagnosis of patients with mild to moderate allergic asthma, merger or not perennial allergic rhinitis; (3) two days scoring at least 2 points of the cleaning period of asthma symptom scores in 3 days ; (4) dust mites, household dust mites skin prick test results determine are all positive, according to the equivalent of histamine ++ or ++ above; (5) dust mites and house dust-mite-specific IgE acuity =0.7 kU/L; (6) Be able to understand and sign informed consent; (7) Good compliance;

Exclusion criteria

Exclusion criteria: (1) with a stomach, spleen, liver, kidney and other severe chronic medical history, medical history, or physical examination found that should not be involved; (2) often badly addicted to drugs, alcohol, smoke more than 20 (daily); (3) with a history of drug allergy; (4) none dust mites allergic patient, such as allergic to pollen in Spring and Autumn, German cockroach, cat, dog fur, whose original skin prick test reaction intensity is stronger than the dust mites allergens, and the results showed positive response more than ++; (5) treating by beta blockers; (6) Was treated by surgery within 4 weeks; (7) used systemic corticosteroids (oral and intravenous drug delivery, etc.) 4 weeks before enrollment; (8) except asthma or allergic rhinitis patients with confirmed by history or signs of any activity, acute or chronic Obstructive pulmonary disease; (9) three times fewer than expected value 60% of the PEF at the acute onset of the patients asthma; (10) with factors of affecting drug absorption, distribution, metabolism and excretion; (11) participated in other drug test within past three months; (12) pregnancy and lactation women or women have a pregnancy plan nearly 1 years in the future; (13) patients with poor compliance of research plan; (14) with a history of specific immune therapy; (15) those to be considered not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Clinical effecacy and safety;

Countries

China

Contacts

Public ContactDehui Wang

The Eye and ENT Hospital of Fudan University

chenlong.li@hotmail.com+86 021-64377134-202

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026