protocolSection identificationModule nctId: NCT06299306, orgStudyIdInfo id: D3250R00116, briefTitle: REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma, acronym: REACT-Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Asthma, Bronchial, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1650, type: ESTIMATED, outcomesModule primaryOutcomes measure: Proportion of severe asthma patients with an Asthma Impairment and Risk Questionnaire (AIRQ®) score at baseline, and at 6 and 12 months post enrollment., secondaryOutcomes measure: Changes in the AIRQ® total score, secondaryOutcomes measure: Bi-weekly changes in the AIRQ® total score over time, secondaryOutcomes measure: Changes in the AIRQ® impairment domain score, secondaryOutcomes measure: Changes in the AIRQ® risk domain score, secondaryOutcomes measure: Proportion of patients with prescribed use of oral corticosteroids (OCS), secondaryOutcomes measure: Proportion of patients with self-reported OCS use, secondaryOutcomes measure: Proportion of patients with a change in other asthma therapies, secondaryOutcomes measure: Treatment switches (change in prescribed therapies) over time and time on treatment., secondaryOutcomes measure: Assessment of the patient satisfaction with digital and analog healthcare, secondaryOutcomes measure: Assessment of the patient-reported 1-year prior healthcare utilization, secondaryOutcomes measure: Assessment of the healthcare provider (physician) satisfaction with digital and analog healthcare, secondaryOutcomes measure: Assessment of the provider preferences in digital versus analog healthcare monitoring., secondaryOutcomes measure: Assessment of the patient preferences towards remote monitoring and healthcare delivery., secondaryOutcomes measure: Number and type of recorded comorbidity-related events overall and in patients with self-reported OCS, secondaryOutcomes measure: Changes in laboratory parameter - IgE level, secondaryOutcomes measure: Changes in lung function parameters - Tiffenau-Index, secondaryOutcomes measure: Correlations between environmental factors and patients' asthma exacerbations, secondaryOutcomes measure: Correlation between environmental factors and changes in AIRQ® score, secondaryOutcomes measure: Changes in laboratory parameter - blood eosinophil, secondaryOutcomes measure: Changes in laboratory parameter - blood neutrophil, secondaryOutcomes measure: Changes in laboratory parameter - FeNO, secondaryOutcomes measure: Changes in laboratory parameter - C-reactive protein (CRP) level, secondaryOutcomes measure: Changes in lung function parameters - FEV1 %, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False