Study Stopped
The early termination of the study is due to challenging recruitment of study sites and patients.
REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma
REACT-Asthma
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
1 other identifier
observational
19
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2024
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2024
CompletedFirst Posted
Study publicly available on registry
March 7, 2024
CompletedStudy Start
First participant enrolled
May 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2024
CompletedSeptember 18, 2025
September 1, 2025
7 months
January 22, 2024
September 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 12 months
Secondary Outcomes (23)
Changes in the AIRQ® total score
Up to 12 months
Bi-weekly changes in the AIRQ® total score over time
Up to 12 months
Changes in the AIRQ® impairment domain score
Up to 12 months
Changes in the AIRQ® risk domain score
Up to 12 months
Proportion of patients with prescribed use of oral corticosteroids (OCS)
Up to 12 months
- +18 more secondary outcomes
Eligibility Criteria
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).
You may qualify if:
- ≥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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (6)
Research Site
Berlin, Germany
Research Site
Blankenhein, Germany
Research Site
Bonn, Germany
Research Site
Fürstenwalde, Germany
Research Site
Gauting, Germany
Research Site
Weißenburg, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2024
First Posted
March 7, 2024
Study Start
May 7, 2024
Primary Completion
November 25, 2024
Study Completion
November 25, 2024
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.