This is a multi-center, single-country, single-arm, prospective, disease study to collect real world data of patients with severe uncontrolled asthma in Germany.
This observational disease study aims to improve the understanding of the real-world situation of patients with severe uncontrolled asthma, the influence of environmental factors on the risk of exacerbations as well as the patients' quality of life. The patients will provide self-reported information about their asthma control and medication use in a 12 months period after study enrollment. Additional patient information will be collected from existing electronical records (EMRs). Furthermore, patient- and provider-reported attitude towards healthcare and monitoring (measured through patient- and provider-reported experience measurements \[PREMs\]) will be collected to measure the level of satisfaction with the healthcare provision, digital and analog healthcare support programs, and the preferences in monitoring tools. The information will be collected either digitally with an application or analogically with paper-based questionnaires.
Study Type
OBSERVATIONAL
Enrollment
19
Research Site
Berlin, Germany
Research Site
Blankenhein, Germany
Research Site
Bonn, Germany
Research Site
Fürstenwalde, Germany
Research Site
Gauting, Germany
Proportion of severe asthma patients with an Asthma Impairment and Risk Questionnaire (AIRQ®) score at baseline, and at 6 and 12 months post enrollment.
To ascertain the level of asthma control of the study population by the AIRQ® assessment. The AIRQ® includes 10 questions (7 assessing symptom impairment and 3 assessing risk) concerning patient medication use, asthma symptoms, medical visits, and tests. The AIRQ® can predict the risk for exacerbations and assess the quality of life of asthma patients. AIRQ® score: well-controlled (0-1 points), not well-controlled (2-4 points) and very poorly controlled (≥5 points) asthma
Time frame: Up to 12 months
Changes in the AIRQ® total score
To assess changes in asthma control compared with baseline assessment.
Time frame: Up to 12 months
Bi-weekly changes in the AIRQ® total score over time
To assess changes in asthma control over time.
Time frame: Up to 12 months
Changes in the AIRQ® impairment domain score
To evaluate changes in quality of life (AIRQ® 7 impairment questions) of patients compared to baseline.
Time frame: Up to 12 months
Changes in the AIRQ® risk domain score
To assess changes in the patients' risk level of exacerbations (AIRQ® 3 risk questions) compared to baseline.
Time frame: Up to 12 months
Proportion of patients with prescribed use of oral corticosteroids (OCS)
To evaluate changes in prescribed daily OCS dose, prescribed cumulative OCS dose, percentage change in prescribed cumulative OCS dose, proportion of patients with prescribed ≤5 mg/day and prescribed \>5mg/day OCS at baseline, months 6 and 12 post enrollment based on information collected via electronic medical records (EMRs).
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Research Site
Weißenburg, Germany
Time frame: Up to 12 months
Proportion of patients with self-reported OCS use
To evaluate changes in self-reported daily OCS dose, cumulative OCS dose, percentage change in cumulative OCS dose, proportion of patients with ≤5 mg/day and \>5mg/day OCS at baseline, months 6 and 12 post enrollment based on information via the AIRQ®-Active app or the paper medication diary.
Time frame: Up to 12 months
Proportion of patients with a change in other asthma therapies
To assess changes in other asthma therapies at 6 and 12 months post enrollment compared to baseline based on prescribed medication as documented in EMRs.
Time frame: Up to 12 months
Treatment switches (change in prescribed therapies) over time and time on treatment.
To assess changes in other asthma therapies over time and time on treatment compared to baseline based on prescribed medication as documented in EMRs.
Time frame: Up to 12 months
Assessment of the patient satisfaction with digital and analog healthcare
To assess the patient-reported attitude towards digital and analog healthcare at months 3, 6, and 12 post enrollment through patient-reported experience measurement (patient PREM) questionnaires. The patient PREM questionnaire includes 16 questions with regard to the experience with the program, the communication/interaction and the evaluation of the program.
Time frame: Up to 12 months
Assessment of the patient-reported 1-year prior healthcare utilization
To assess the patient-reported healthcare utilization (HCRU) at 12 months post enrollment compared with baseline assessment. The patient HCRU questionnaire includes 4 questions with regard to healthcare utilization.
Time frame: 12 months
Assessment of the healthcare provider (physician) satisfaction with digital and analog healthcare
To assess the healthcare provider-reported attitude towards digital and analog healthcare and provider-reported preferences in monitoring tools through provider-reported experience measurement (provider PREM) questionnaires at months 3, 6, and 12 post recruitment. The provider PREM questionnaire assessing the satisfaction with digital and analog healthcare includes 15 questions with regard to the experience with the program, the communication/interaction and the evaluation of the program.
Time frame: Up to 12 months
Assessment of the provider preferences in digital versus analog healthcare monitoring.
To assess the provider-reported preferences in monitoring tools through provider-reported experience measurement (provider PREM) questionnaires at months 3, 6, and 12 post recruitment. The provider PREM questionnaire assessing the preferences in digital and analog healthcare includes 3 questions with regard to integration and communication, medicinal benefit, and economic benefit.
Time frame: Up to 12 months
Assessment of the patient preferences towards remote monitoring and healthcare delivery.
To elicit the preferences of patients towards remote monitoring and healthcare delivery over time using a Discrete Choice Experiment (DCE) questionnaire at baseline and 6 months post enrollment. The DCE questionnaire is a 4 choice task based questionnaire.
Time frame: 6 months
Number and type of recorded comorbidity-related events overall and in patients with self-reported OCS
To describe the number of comorbidity-related events during the study among overall patients and in the subgroup of patients with self-reported OCS use based on information collected via electronic case report form (eCRF).
Time frame: Baseline
Changes in laboratory parameter - IgE level
To evaluate patients' IgE level. Counts of IgE, measured in kilounits per liter (kU/L) or international units per liter (IU/mL)
Time frame: Up to 12 months
Changes in lung function parameters - Tiffenau-Index
To evaluate changes in lung function by using a spirometer. From the spirometry measurements (FEV1, FVC) the Tiffenau-Index (FEV1/FVC) will be calculated.
Time frame: Up to 12 months
Correlations between environmental factors and patients' asthma exacerbations
To evaluate the relationship of environmental factors like levels of allergen flight, fine particle load, ozone levels, air pollution, and duration of sunshine related to asthma exacerbations at 6 months and 12 months based on environmental databases.
Time frame: Up to 12 months
Correlation between environmental factors and changes in AIRQ® score
To evaluate the relationship of environmental factors like levels of allergen flight, fine particle load, ozone levels, air pollution, and duration of sunshine related to the patients´well-being (AIRQ® score) at 6 months and 12 months based on information of environmental databases.
Time frame: Up to 12 months
Changes in laboratory parameter - blood eosinophil
To evaluate the level of patients' blood eosinophil. Counts of blood eosinophils, measured in cells per microliter or percentage (%) of the total cell count.
Time frame: Up to 12 months
Changes in laboratory parameter - blood neutrophil
To evaluate the level of patients' blood neutrophil. Counts of blood neutrophil, measured in cells per microliter or percentage (%) of the total cell count.
Time frame: Up to 12 months
Changes in laboratory parameter - FeNO
To evaluate patients' FeNO concentration. Measurements of FeNO concentration in exhaled breath, measured in parts per billion (ppb) at a flow rate of 50 milliliters per second (mL/s)
Time frame: Up to 12 months
Changes in laboratory parameter - C-reactive protein (CRP) level
To evaluate patients' C-reactive protein (CRP) level. Measured in milligrams per liter (mg/L)
Time frame: Up to 12 months
Changes in lung function parameters - FEV1 %
To evaluate changes in lung function by using a spirometer. From the spirometry measurements (FEV1) the predicted FEV1 % will be calculated.
Time frame: Up to 12 months