Clinical trial NCT06299306: REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma
Official title: REACT - REAl Care for AsThma A Disease Study to Identify Patients With Severe Uncontrolled Asthma Using EMR Pre-screening and AIRQ® Score Documentation Over 12 Months, Including Patient-documented OCS Use With the AIRQ®-Active Application
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma, Bronchial
Keywords: severe Asthma
real-world evidence
quality of life
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of severe asthma patients within GINA/NVL (Global Initiative for Asthma/ Nationale Versorgungsleitlinie) steps 4 or 5 with uncontrolled disease (including patients on biologics but without any prescribed oral corticosteroids).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age at the time of consent
* Therapy within GINA/NVL steps 4 or 5 and uncontrolled disease in the previous 12 months as per the healthcare provider's assessment
* Willing and able to provide written informed consent indicating that they understand the purpose and procedures required for the study and are willing to participate
* Able to read, understand, and speak German sufficiently to complete all the questionnaires

Exclusion Criteria:

* According to the assessment of the study physician: cognitive impairment, psychiatric diseases, severe hearing or vision impairment, insufficient knowledge of the German language, if these factors could influence the ability to provide written consent and correct completion and assessment of the questionnaires.
* Current participation in an observational study that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomized clinical trial in the last 30 days.

Primary outcomes:
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.
timeFrame: Up to 12 months
Secondary outcomes:
measure: Changes in the AIRQ® total score
timeFrame: Up to 12 months
measure: Bi-weekly changes in the AIRQ® total score over time
timeFrame: Up to 12 months
measure: Changes in the AIRQ® impairment domain score
timeFrame: Up to 12 months
measure: Changes in the AIRQ® risk domain score
timeFrame: Up to 12 months
measure: Proportion of patients with prescribed use of oral corticosteroids (OCS)
timeFrame: Up to 12 months
measure: Proportion of patients with self-reported OCS use
timeFrame: Up to 12 months
measure: Proportion of patients with a change in other asthma therapies
timeFrame: Up to 12 months
measure: Treatment switches (change in prescribed therapies) over time and time on treatment.
timeFrame: Up to 12 months
measure: Assessment of the patient satisfaction with digital and analog healthcare
timeFrame: Up to 12 months
measure: Assessment of the patient-reported 1-year prior healthcare utilization
timeFrame: 12 months
measure: Assessment of the healthcare provider (physician) satisfaction with digital and analog healthcare
timeFrame: Up to 12 months
measure: Assessment of the provider preferences in digital versus analog healthcare monitoring.
timeFrame: Up to 12 months
measure: Assessment of the patient preferences towards remote monitoring and healthcare delivery.
timeFrame: 6 months
measure: Number and type of recorded comorbidity-related events overall and in patients with self-reported OCS
timeFrame: Baseline
measure: Changes in laboratory parameter - IgE level
timeFrame: Up to 12 months
measure: Changes in lung function parameters - Tiffenau-Index
timeFrame: Up to 12 months
measure: Correlations between environmental factors and patients' asthma exacerbations
timeFrame: Up to 12 months
measure: Correlation between environmental factors and changes in AIRQ® score
timeFrame: Up to 12 months
measure: Changes in laboratory parameter - blood eosinophil
timeFrame: Up to 12 months
measure: Changes in laboratory parameter - blood neutrophil
timeFrame: Up to 12 months
measure: Changes in laboratory parameter - FeNO
timeFrame: Up to 12 months
measure: Changes in laboratory parameter - C-reactive protein (CRP) level
timeFrame: Up to 12 months
measure: Changes in lung function parameters - FEV1 %
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
city: Blankenhein
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Fuerstenwalde
country: Germany
facility: Research Site
city: Gauting
country: Germany
facility: Research Site
city: Weissenburg
country: Germany
facility: Research Site
Study officials:
References: