Trial · NCT00809757
A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma
NCT00809757, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2014-07-28
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ConductScience Library. A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma. Trials, record NCT00809757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00809757
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma
- NCT number
- NCT00809757
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 197 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Asthma
- Interventions
- Levalbuterol, Levalbuterol UDV TID, Placebo
- First posted
- 2008-12-17
- Last updated
- 2014-07-28
- Results first posted
- 2014-07-28
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA) | Baseline, Visit 4 (Week 4) | The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4. |
| Secondary | Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | Baseline, Visit 3 (Week 3) | The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3. |
| Secondary | Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days | The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3. |
| Secondary | Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days | The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4. |
| Secondary | Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ) | Baseline, Visit 3 (Week 3) | The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3. |
| Secondary | Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire | Baseline, Visit 4 (Week 4) | The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4. |
| Secondary | Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire | The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days | The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3. |
| Secondary | Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire | The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days | The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4. |
| Secondary | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose | Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort |
| Secondary | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3 | Baseline, Visit 3, pre-dose (approximately 14 days after randomization) |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA) | Baseline, Visit 4 (Week 4) | Intent-to-Treat Population. Only those subjects who had non-missing data at Week 4 and at Baseline were included. Subjects who discontinued from the study prior to Week 4 are not included in this analysis | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | Baseline, Visit 3 (Week 3) | Intent-to-Treat Population | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days | Intent-to-Treat Population | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days | Intent-to-Treat Population | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ) | Baseline, Visit 3 (Week 3) | Intent-to-Treat Population | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire | Baseline, Visit 4 (Week 4) | Intent-to-Treat Population | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire | The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days | Intent-to-Treat Population | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire | The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days | Intent-to-Treat Population | units on a scale | MEAN |
| SECONDARY | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose | Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs) | liters | MEAN |
| SECONDARY | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3 | Baseline, Visit 3, pre-dose (approximately 14 days after randomization) | Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs) | liters | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group234
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA) | Placebo | -1.21 | Standard Deviation 2.722 | units on a scale | |
| Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA) | Levalbuterol MDI | -0.67 | Standard Deviation 2.092 | units on a scale | |
| Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA) | Levalbuterol UDV | -0.52 | Standard Deviation 2.843 | units on a scale | |
| Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | Placebo | -0.83 | Standard Deviation 2.913 | units on a scale | |
| Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | Levalbuterol MDI | -0.28 | Standard Deviation 2.490 | units on a scale | |
| Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | Levalbuterol UDV | -0.22 | Standard Deviation 2.545 | units on a scale | |
| Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | Placebo | -0.82 | Standard Deviation 2.417 | units on a scale | |
| Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | Levalbuterol MDI | -0.25 | Standard Deviation 2.041 | units on a scale | |
| Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | Levalbuterol UDV | -0.15 | Standard Deviation 2.067 | units on a scale | |
| Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | Placebo | -1.08 | Standard Deviation 2.478 | units on a scale |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 68 | |
| Overall Study | STARTED | Levalbuterol MDI | 65 | |
| Overall Study | STARTED | Levalbuterol UDV | 64 | |
| Overall Study | COMPLETED | Placebo | 62 | |
| Overall Study | COMPLETED | Levalbuterol MDI | 60 | |
| Overall Study | COMPLETED | Levalbuterol UDV | 53 | |
| Overall Study | NOT COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Levalbuterol MDI | 5 | |
| Overall Study | NOT COMPLETED | Levalbuterol UDV | 11 |
Source ClinicalTrials.gov
Adverse events63
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 | Abdominal Pain Upper | Gastrointestinal disorders | Placebo | 0 | 68 | 0 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Levalbuterol MDI | 2 | 65 | 2 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Levalbuterol UDV | 0 | 63 | 0 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 2 | 68 | 2 |
| other | Vomiting | Gastrointestinal disorders | Levalbuterol MDI | 3 | 65 | 3 |
| other | Vomiting | Gastrointestinal disorders | Levalbuterol UDV | 2 | 63 | 2 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 68 | 3 |
| other | Nasopharyngitis | Infections and infestations | Levalbuterol MDI | 1 | 65 | 1 |
| other | Nasopharyngitis | Infections and infestations | Levalbuterol UDV | 1 | 63 | 1 |
| other | Sinusitis | Infections and infestations | Placebo | 0 | 68 | 0 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Levalbuterol MDI | ||
| Total, all-cause mortality | Levalbuterol UDV | ||
| Total, other adverse events | Placebo | 28 | 68 |
| Total, other adverse events | Levalbuterol MDI | 31 | 65 |
| Total, other adverse events | Levalbuterol UDV | 27 | 63 |
| Total, serious adverse events | Placebo | 0 | 68 |
| Total, serious adverse events | Levalbuterol MDI | 1 | 65 |
| Total, serious adverse events | Levalbuterol UDV | 3 | 63 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00809757
GET https://conductscience.org/api/trials/v1/NCT00809757/registered?page=2