Trial · NCT02150499
A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects
NCT02150499, Phase 3, Terminated, Sumitomo Pharma America, Inc.; results first posted 2016-02-03
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects. Trials, record NCT02150499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02150499
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects
- NCT number
- NCT02150499
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 18 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Asthma
- Interventions
- levalbuterol tartrate HFA inhalation aerosol, placebo
- First posted
- 2014-05-30
- Last updated
- 2016-04-08
- Results first posted
- 2016-02-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events. | Week 1 | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. |
| Primary | The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events. | Week 1 | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. |
| Primary | The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation. | Week 1 | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. |
| Secondary | Change From Baseline in Pulmonary Score (Total Score) to End of Treatment | Day 1 | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. |
| Secondary | Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment | Day 1 | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. |
| Secondary | Change From Baseline in Pulmonary Score (Total Score) After Each Dose | 20 minutes, 40 minutes, 60 minutes | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. |
| Secondary | Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose | 20 minutes, 40 minutes, 60 minutes | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. |
| Secondary | Number and Percentage of Subjects Determined to be Stabilized After Treatment | Day 1 | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events. | Week 1 | Number of Adverse Events | NUMBER | |
| PRIMARY | The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events. | Week 1 | Number of Serious Adverse Events | NUMBER | |
| PRIMARY | The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation. | Week 1 | Number of Discontinuations | NUMBER | |
| SECONDARY | Change From Baseline in Pulmonary Score (Total Score) to End of Treatment | Day 1 | |||
| SECONDARY | Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment | Day 1 | |||
| SECONDARY | Change From Baseline in Pulmonary Score (Total Score) After Each Dose | 20 minutes, 40 minutes, 60 minutes | |||
| SECONDARY | Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose | 20 minutes, 40 minutes, 60 minutes | |||
| SECONDARY | Number and Percentage of Subjects Determined to be Stabilized After Treatment | Day 1 |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events. | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 4 | Number of Adverse Events | ||
| The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events. | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 6 | Number of Adverse Events | ||
| The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events. | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 0 | Number of Serious Adverse Events | ||
| The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events. | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 0 | Number of Serious Adverse Events | ||
| The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation. | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 0 | Number of Discontinuations | ||
| The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation. | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 0 | Number of Discontinuations |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 9 | |
| Overall Study | STARTED | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 9 | |
| Overall Study | COMPLETED | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 9 | |
| Overall Study | COMPLETED | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 9 | |
| Overall Study | NOT COMPLETED | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 0 | |
| Overall Study | NOT COMPLETED | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 0 |
Source ClinicalTrials.gov
Adverse events20
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 | Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 0 | 9 | 0 |
| other | Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 1 | 9 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 0 | 9 | 0 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 1 | 9 | 1 |
| other | Existaxis | Respiratory, thoracic and mediastinal disorders | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 1 | 9 | 1 |
| other | Existaxis | Respiratory, thoracic and mediastinal disorders | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 0 | 9 | 0 |
| other | Stridor | Respiratory, thoracic and mediastinal disorders | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 1 | 9 | 1 |
| other | Stridor | Respiratory, thoracic and mediastinal disorders | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 0 | 9 | 0 |
| other | Tachycardia | Cardiac disorders | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 0 | 9 | 0 |
| other | Tachycardia | Cardiac disorders | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 1 | 9 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | ||
| Total, all-cause mortality | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | ||
| Total, other adverse events | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 2 | 9 |
| Total, other adverse events | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 2 | 9 |
| Total, serious adverse events | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | 0 | 9 |
| Total, serious adverse events | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | 0 | 9 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA vs Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol: serious adverse events |
Source 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.
GET https://conductscience.org/api/trials/v1/NCT02150499
GET https://conductscience.org/api/trials/v1/NCT02150499/registered