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

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 - NOVUS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032532

Enrollment

1000

Registered

2023-08-24

Start date

2023-07-19

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

J30.3 J30.4 H10.1 J45.0

Interventions

Group 1: Prospective data collection on patients starting treatment with the One Strength dose escalation scheme of Novo Helisen® (D.p./D.f., 50/50% by vol.) between July 2023 and September 2024 . Da

Eligibility

Sex/Gender

All

Age

12 Years to 12 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
• 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. • 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

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

Measure

Time frame

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

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Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026