Comparison · NCT03890666-sae
Concurrent Control (CC) vs Digital System (DS): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Concurrent Control (CC) vs Digital System (DS): serious adverse events. Trial comparisons, record NCT03890666-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03890666-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00602 | 0.00106 | 0.0333 | wilson | |
| Risk in group 2 | 0.00667 | 0.00118 | 0.0368 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000643 | -0.0312 | 0.0272 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.904 | 0.057 | 14.3 | log | |
| Odds ratio, group 1 over group 2 | 0.903 | 0.056 | 14.6 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Concurrent Control (CC) than on Digital System (DS) | 1,560 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Concurrent Control (CC) | Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications. | 1 | 166 | EG000 |
| Group 2 | Digital System (DS) | Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks. | 1 | 150 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to Week 14
Source ClinicalTrials.gov
Trial
- Title
A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma
- NCT number
- NCT03890666
- Phases
- PHASE4
- Conditions
- Asthma
- Interventions
- Albuterol eMDPI DS, albuterol
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Results first posted
- 2022-10-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03890666?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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