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The Effectiveness, Safety and Compliance of Oraltek Sublingual Immunotherapy Real World Study

The Effectiveness, Safety and Compliance of Oraltek Sublingual Immunotherapy Real World Study - Oraltek Real World Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089014
Enrollment
Unknown
Registered
2024-08-30
Start date
2024-05-09
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

Allergic rhinitis/conjunctivitis

Interventions

Oraltek group (Apply Oraltek Sublingual Spray):None

Sponsors

Shulan (Bo'ao) Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to No maximum

Inclusion criteria

Inclusion criteria: a. Patients must sign an informed consent form and possess the ability to adhere to study requirements; b. Age =5 years, both males and females are eligible; c. Diagnosed with allergic rhinitis/conjunctivitis with or without mild to moderate asthma, according to the criteria set by the ARIA guidelines and GINA 2023; d. Patients test positive for skin prick tests or specific IgE tests for one or more of the following allergens: house dust mites or dust mites, cat dander, dog dander, Alternaria alternata, horse dander, Artemisia vulgaris, Betula pendula/Alnus glutinosa/ Corylus avellana, 6 grasses (Holcus lanatus, Dactylis glomerata, Festuca pratensis, Poa pratensis, Lolium perenne, Phleum pratense) , Ambrosia artemisiifolia.

Exclusion criteria

Exclusion criteria: a. Patients with FEV1% < 80%, those with uncontrolled asthma, or severe asthma patients; b. Patients receiving treatment with ß-blockers or angiotensin-converting enzyme (ACE) inhibitors; c. Pregnant or breastfeeding women; d. Patients who are unable to understand or cooperate; e. Other patients deemed unsuitable for desensitization treatment by a physician.

Design outcomes

Primary

MeasureTime frame
Rhinitis Combined Symptom and Medication Score;Asthma Combined Symptom and Medication Score;

Secondary

MeasureTime frame
VAS score;Common Adverse Reactions and Incidence;Patient dropout rate;Differences in adherence to desensitization therapy in patients with different allergens/ages and analysis of the reasons;Cost of treatment and its impact on adherence;

Countries

China

Contacts

Public ContactYuefeng Sun

Hainan Shulan Bo'ao Hospital Co., Ltd.

yuefeng.sun@shulan.com+86 138 6817 4688

Outcome results

None listed

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