Prospective, multi-centre, non-interventional study on the use, tolerability and safety of the One Strength dose escalation scheme with NOVo Helisen® hoUSe dust mites in everyday practice

Recruiting

• Conditions: J30.3; J30.4; H10.1; J45.0; Other allergic rhinitis; Allergic rhinitis, unspecified; Acute atopic conjunctivitis; Predominantly allergic asthma

• Registration Number: DRKS00032532
• Lead Sponsor: Allergopharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Written informed consent from the patient. In the case of patients under the age of 18, the consent of both parents/legal guardians is also required.
2. Patients treatment with the One-Strength dose escalation scheme of NH (D.p./D.f.) must be approved, in accordance with the specifications of the SmPC. This includes adolescents (=12 and <18 years) and adults with allergic (IgE-mediated) diseases such as allergic rhinitis, allergic conjunctivitis, allergic bronchial asthma (see section 4 of the current SmPC).
3. The therapy decision must precede the decision to participate in the study and must be independent.

Exclusion Criteria

1. Any contraindication according to section 4.3 of the current SmPC for NH (D.p./D.f.) for the One-Strength dose escalation scheme.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Administration (e.g. time, frequency, dose, injection site) of the One Strength dose escalation scheme is assessed at every study visit ( = injections 1 - 8) in physician's routine practice.<br>• The tolerability of the individual injections (injection 1-7) and the overall tolerability is evaluated using a 5-point Likert scale (Likert 1932) by the attending physicians and the patients.

Secondary Outcome Measures

Name	Time	Method
Safety data on the One Strength dose escalation scheme are collected on every visit (= injections 1-8) in routine practice. Collected safety data include:<br>- Number, frequency, type, intensity and time of occurrence of (serious) adverse drug reactions ((S)ADRs)<br>- Frequency and intensity of systemic allergic reactions<br>- Percentage of patients who reach the maintenance dose without/with dose adjustment.