Non-interventional study National Eklira® Evaluation and Documentation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00006861

Enrollment

6000

Registered

2014-10-13

Start date

2014-10-20

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

J44.9

Interventions

Group 1: Adult patients (at least 40 years old) suffering from COPD and for whom therapy with Eklira Genuair is planned or exists are examined.

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: • At least 40 years of age; • Diagnosed COPD; • Current or newly initiated treatment with Eklira® Genuair®; • Patient’s informed consent has been obtained.

Exclusion criteria

Exclusion criteria: • Contraindications to the use of anticholinergics in accordance with the Eklira® Genuair® Summary of Product Characteristics (SPC): acute urinary retention, symptomatic prostatic hypertrophy, bladder neck obstruction, or narrow-angle glaucoma; • Pregnancy/lactation; • Hypersensitivity to aclidinium bromide, atropine or its derivatives, including ipratropium, oxitropium or tiotropium.

Design outcomes

Primary

Measure	Time frame
The aim of this non-interventional study is to document treatment effect, handling and tolerability of Eklira® Genuair® in the treatment of COPD under real-life conditions in pulmonology and primary care practices. The main focus is on a patient-oriented assessment of therapy and the characterization of the patient with new Eklira® Genuair® therapy. The following aspects are of particular interest: • Disease-related quality of life of patients treated with Eklira® Genuair® (COPD Assessment Test (CAT), Visits 1-4 (at intervals of 3 months)) • Nocturnal and morning symptoms of COPD (Questionnaire: COPD symptoms at night and in the morning (NiSCI, EMSCI), Visits 1-4 (at intervals of 3 months)) • Patient satisfaction with Eklira® Genuair ® therapy (Quationnaire for assessment of inhalator: Handling, convenience, handling easy to understand, grip, operability, dosage easy to prime, control mechanism for correct inhalation, Visit 4 (9 months after baseline)) • Handling of Eklira® Genuair® (frequency of use, Visits 1-4 (at intervals of 3 months))	—

Measure

Time frame

The aim of this non-interventional study is to document treatment effect, handling and tolerability of Eklira® Genuair® in the treatment of COPD under real-life conditions in pulmonology and primary care practices. The main focus is on a patient-oriented assessment of therapy and the characterization of the patient with new Eklira® Genuair® therapy. The following aspects are of particular interest: • Disease-related quality of life of patients treated with Eklira® Genuair® (COPD Assessment Test (CAT), Visits 1-4 (at intervals of 3 months)) • Nocturnal and morning symptoms of COPD (Questionnaire: COPD symptoms at night and in the morning (NiSCI, EMSCI), Visits 1-4 (at intervals of 3 months)) • Patient satisfaction with Eklira® Genuair ® therapy (Quationnaire for assessment of inhalator: Handling, convenience, handling easy to understand, grip, operability, dosage easy to prime, control mechanism for correct inhalation, Visit 4 (9 months after baseline)) • Handling of Eklira® Genuair® (frequency of use, Visits 1-4 (at intervals of 3 months))

—

Countries

Germany

Contacts

Public ContactSandra Höpfert

ANFOMED GmbH CRO

sandra.hoepfert@anfomed.de09133776228

Outcome results

None listed

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