This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
REACT Asthma was a clinical study designed to characterize asthma control in patients with severe uncontrolled asthma using AIRQ® assessments collected at baseline and after enrollment.
| Feature | REACT Asthma |
|---|---|
| Title | REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma |
| Status | Terminated |
| Condition | Asthma, Bronchial |
| Lead sponsor | AstraZeneca |
| Sponsor type | Industry |
| Primary completion date | 2024-11-25 |
2. Clinical Question
Population
Patients with severe uncontrolled asthma included in the REACT Asthma study.
Intervention
The registry describes a disease study evaluating asthma control in real care settings.
Comparator
No randomized comparator arm is reported in the registry record.
Primary Question
What is the level of asthma control in the study population based on AIRQ® assessments?
3. Trial Design
19 patients
AIRQ® score
6 months
12 months
The ClinicalTrials.gov record describes REACT Asthma as a disease study intended to identify patients with severe uncontrolled asthma. The registry does not report randomization, masking, crossover, factorial structure, interim analysis, or non-inferiority methodology.
4. Endpoints
| Endpoint | Time Frame | Description |
|---|---|---|
| Proportion of severe asthma patients with an Asthma Impairment and Risk Questionnaire (AIRQ®) score at baseline, and at 6 and 12 months post enrollment | Up to 12 months | The AIRQ® includes 10 questions (7 assessing symptom impairment and 3 assessing risk) concerning patient medication use, asthma symptoms, medical visits, and tests. AIRQ® scores classify asthma as well-controlled (0-1 points), not well-controlled (2-4 points), and very poorly controlled (≥5 points). |
5. Statistical Methodology
The primary endpoint is a longitudinal assessment of AIRQ® score categories and measurements over time. For a study of this type, statistical analysis would typically focus on describing changes in questionnaire scores and the proportion of patients within each asthma-control category at the defined assessment visits.
The registry does not report the planned statistical analysis details beyond the endpoint description.
6. Planned Analysis
The registry states that the study will assess AIRQ® scores at baseline, 6 months, and 12 months post enrollment. No results have been posted on ClinicalTrials.gov.
For a repeated questionnaire endpoint, common statistical approaches include summarizing score distributions over time, estimating changes from baseline, and evaluating the proportion of participants meeting predefined control categories. The exact method depends on the prespecified statistical analysis plan.
7. Statistical Methods Explained
How is AIRQ® different from a single symptom measurement?
AIRQ® combines multiple domains, including symptom impairment and risk assessment, into a structured asthma-control evaluation.
Why measure patients at multiple time points?
Baseline, 6-month, and 12-month measurements allow investigators to describe how asthma-control assessments change over follow-up.
Why report proportions?
A proportion describes how many patients fall within a defined category, such as well-controlled, not well-controlled, or very poorly controlled asthma.
Why are descriptive analyses important in disease studies?
When the objective is characterization of a patient population, descriptive summaries can provide information about disease burden and patient status.
Why does the analysis plan matter?
The prespecified statistical analysis determines how measurements are summarized, compared, and interpreted.
8. Safety Results
The ClinicalTrials.gov record does not report serious adverse events by study arm.
9. Limitations
- No posted results: The registry does not report outcome results for the primary endpoint.
- Small enrollment: The study enrollment was 19 participants, which limits precision for estimating proportions or changes over time.
- No comparator: The registry does not describe a randomized comparator group.
- Generalizability: Findings from a defined study population may not represent all individuals with asthma.
- Statistical uncertainty: Estimates based on small samples generally have greater uncertainty.
10. Why This Trial Matters Statistically
| Concept | How it appears in REACT Asthma |
|---|---|
| Patient-reported outcomes | AIRQ® provides a structured assessment of asthma impairment and risk. |
| Longitudinal measurement | Scores are assessed at baseline and follow-up visits. |
| Categorical outcomes | AIRQ® categories classify asthma control levels. |
| Descriptive statistics | Appropriate summaries characterize disease-control patterns. |
11. Related Tutorials
No related tutorials are available for this trial.
12. Related Calculators
No related calculators are available for this trial.
13. Sources
- ClinicalTrials.gov record: REACT Asthma (NCT06299306)