Asthma, BronchialREACT-AsthmaNCT06299306
REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma
An observational study of Asthma, Bronchial, run by AstraZeneca at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Asthma, Bronchial
- How many people
- 19 participants
- Where
- 6 sitesGermany
- Study dates
- 7 May 2024to 25 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- ≥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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Research Site
Berlin
Research Site
Blankenhein
Research Site
Bonn
Research Site
Fürstenwalde
Research Site
Gauting
Research Site
Weißenburg
About this study
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
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.
Read the 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.
- Conditions
- Asthma, Bronchial
- Keywords
- severe Asthma, real-world evidence, quality of life
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 months
Secondary outcomes (23)
Changes in the AIRQ® total score
To assess changes in asthma control compared with baseline assessment.
Measured: Up to 12 months
Bi-weekly changes in the AIRQ® total score over time
To assess changes in asthma control over time.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start7 May 2024
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Why it stopped: The early termination of the study is due to challenging recruitment of study sites and patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, BronchialStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299306
- Sponsor's protocol ID
- D3250R00116
- Acronym
- REACT-Asthma
- Status last verified
- Sep 2025
- First submitted
- 22 Jan 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06299306
- Acronym / sponsor ID
- REACT-Asthma / D3250R00116
- Conditions
- Asthma, Bronchial
- Keywords
- severe Asthma, real-world evidence, quality of life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The early termination of the study is due to challenging recruitment of study sites and patients.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of severe asthma patients with an Asthma Impairment and Risk Questionnaire (AIRQ®) score at baseline, and at 6 and 12 months post enrollment.
Time frame: Up to 12 months
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
23 secondary outcomes
Changes in the AIRQ® total score
Time frame: Up to 12 months
Bi-weekly changes in the AIRQ® total score over time
Time frame: Up to 12 months
Changes in the AIRQ® impairment domain score
Time frame: Up to 12 months
Changes in the AIRQ® risk domain score
Time frame: Up to 12 months
Proportion of patients with prescribed use of oral corticosteroids (OCS)
Time frame: Up to 12 months
Proportion of patients with self-reported OCS use
Time frame: Up to 12 months
Proportion of patients with a change in other asthma therapies
Time frame: Up to 12 months
Treatment switches (change in prescribed therapies) over time and time on treatment.
Time frame: Up to 12 months
Assessment of the patient satisfaction with digital and analog healthcare
Time frame: Up to 12 months
Assessment of the patient-reported 1-year prior healthcare utilization
Time frame: 12 months
Assessment of the healthcare provider (physician) satisfaction with digital and analog healthcare
Time frame: Up to 12 months
Assessment of the provider preferences in digital versus analog healthcare monitoring.
Time frame: Up to 12 months
Assessment of the patient preferences towards remote monitoring and healthcare delivery.
Time frame: 6 months
Number and type of recorded comorbidity-related events overall and in patients with self-reported OCS
Time frame: Baseline
Changes in laboratory parameter - IgE level
Time frame: Up to 12 months
Changes in lung function parameters - Tiffenau-Index
Time frame: Up to 12 months
Correlations between environmental factors and patients' asthma exacerbations
Time frame: Up to 12 months
Correlation between environmental factors and changes in AIRQ® score
Time frame: Up to 12 months
Changes in laboratory parameter - blood eosinophil
Time frame: Up to 12 months
Changes in laboratory parameter - blood neutrophil
Time frame: Up to 12 months
Changes in laboratory parameter - FeNO
Time frame: Up to 12 months
Changes in laboratory parameter - C-reactive protein (CRP) level
Time frame: Up to 12 months
Changes in lung function parameters - FEV1 %
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: The early termination of the study is due to challenging recruitment of study sites and patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, Bronchial, run by AstraZeneca at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The early termination of the study is due to challenging recruitment of study sites and patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.