Trial · NCT03890666
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
NCT03890666, Phase 4, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2022-10-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03890666. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03890666
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 333 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Asthma
- Interventions
- Albuterol eMDPI DS, albuterol
- First posted
- 2019-03-26
- Last updated
- 2026-03-19
- Results first posted
- 2022-10-27
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period | Baseline to Week 12 | Meaningful asthma improvement was defined as an Asthma Control Test (ACT) score of at least 20 at the end of the 12-week treatment period or an increase of at least 3 units on the ACT score from baseline at the end of the 12-week treatment period. The ACT was a simple, participant-completed tool used to assess overall asthma control. The 5 items included in the ACT assess daytime and night-time asthma symptoms, use of reliever medication, and impact of asthma on daily functioning. Each item in the ACT was scored on a 5-point scale, with a summation of all items providing scores ranging from 5 to 25. The scores span the continuum of poor control of asthma (score of 5) to complete control of asthma (score of 25), with a cutoff score of 19 and below indicating participants with poorly controlled asthma. |
| Secondary | Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence | Baseline up to Week 12 | Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported. |
| Secondary | Number of Decreased Doses of Inhaled Medication | Baseline up to Week 12 | Number of participants who received decreased dose of inhaled medication during the 12-week treatment period are reported. |
| Secondary | Number of Increased Doses of Inhaled Medication | Baseline up to Week 12 | Number of participants who received increased dose of inhaled medication during the 12-week treatment period are reported. |
| Secondary | Number of Changes to Different Inhaled Medication | Baseline up to Week 12 | Number of participants who received different inhaled medication during the 12-week treatment period are reported. |
| Secondary | Number of Additional Inhaled Medication | Baseline up to Week 12 | Number of participants who received additional inhaled medication during the 12-week treatment period are reported. |
| Secondary | Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy | Baseline up to Week 12 | Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 12-week treatment period are reported. |
| Secondary | Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control | Baseline up to Week 12 | Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported. |
| Secondary | Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group | Baseline, Week 12 | |
| Secondary | Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group | Baseline, Week 12 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period | Baseline to Week 12 | mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. | percentage of participants | NUMBER |
| SECONDARY | Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence | Baseline up to Week 12 | mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Decreased Doses of Inhaled Medication | Baseline up to Week 12 | mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Increased Doses of Inhaled Medication | Baseline up to Week 12 | mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Changes to Different Inhaled Medication | Baseline up to Week 12 | mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Additional Inhaled Medication | Baseline up to Week 12 | mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy | Baseline up to Week 12 | mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control | Baseline up to Week 12 | mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group | Baseline, Week 12 | mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | mcg | MEAN |
| SECONDARY | Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group | Baseline, Week 12 | mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | days | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group65
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period | Concurrent Control (CC) | 54.6 | percentage of participants | ||
| Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period | Digital System (DS) | 61.33 | percentage of participants | ||
| Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence | Concurrent Control (CC) | No discussion | 121 | Participants | |
| Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence | Digital System (DS) | No discussion | 87 | Participants | |
| Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence | Concurrent Control (CC) | 1 discussion | 38 | Participants | |
| Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence | Digital System (DS) | 1 discussion | 39 | Participants | |
| Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence | Concurrent Control (CC) | 2 discussions | 3 | Participants | |
| Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence | Digital System (DS) | 2 discussions | 7 | Participants | |
| Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence | Concurrent Control (CC) | 3 discussions | 0 | Participants | |
| Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence | Digital System (DS) | 3 discussions | 6 | Participants |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Concurrent Control (CC) | 166 | |
| Overall Study | STARTED | Digital System (DS) | 167 | |
| Overall Study | Safety Analysis Set | Concurrent Control (CC) | 166 | |
| Overall Study | Safety Analysis Set | Digital System (DS) | 150 | |
| Overall Study | Modified Intent-to-treat (mITT) Analysis Set | Concurrent Control (CC) | 163 | |
| Overall Study | Modified Intent-to-treat (mITT) Analysis Set | Digital System (DS) | 150 | |
| Overall Study | COMPLETED | Concurrent Control (CC) | 162 | |
| Overall Study | COMPLETED | Digital System (DS) | 149 | |
| Overall Study | NOT COMPLETED | Concurrent Control (CC) | 4 | |
| Overall Study | NOT COMPLETED | Digital System (DS) | 18 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Concurrent Control (CC) | 8 | 166 | 9 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Digital System (DS) | 11 | 150 | 12 |
| serious | COVID-19 pneumonia | Infections and infestations | Concurrent Control (CC) | 1 | 166 | 1 |
| serious | COVID-19 pneumonia | Infections and infestations | Digital System (DS) | 0 | 150 | 0 |
| serious | SARS-CoV-2 sepsis | Infections and infestations | Concurrent Control (CC) | 1 | 166 | 1 |
| serious | SARS-CoV-2 sepsis | Infections and infestations | Digital System (DS) | 0 | 150 | 0 |
| serious | Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Concurrent Control (CC) | 0 | 166 | 0 |
| serious | Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Digital System (DS) | 1 | 150 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Concurrent Control (CC) | 0 | 166 |
| Total, all-cause mortality | Digital System (DS) | 0 | 150 |
| Total, other adverse events | Concurrent Control (CC) | 8 | 166 |
| Total, other adverse events | Digital System (DS) | 11 | 150 |
| Total, serious adverse events | Concurrent Control (CC) | 1 | 166 |
| Total, serious adverse events | Digital System (DS) | 1 | 150 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Concurrent Control (CC) vs Digital System (DS): deaths from any cause | Trial comparisons |
| Concurrent Control (CC) vs Digital System (DS): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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