Trial · NCT00583947
A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
NCT00583947, Phase 2, Completed, Sumitomo Pharma America, Inc.; results first posted 2010-02-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects. Trials, record NCT00583947. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00583947
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
- NCT number
- NCT00583947
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Asthma
- Interventions
- arformoterol, levalbuterol
- First posted
- 2008-01-02
- Last updated
- 2012-02-22
- Results first posted
- 2010-02-08
- Limitations and caveats
Sample size was determined outside of statistical considerations. All data recorded at/after Visit 8 for 6 subjects, misdosed with ARF 7.5mcg instead of ARF 15mcg in open-label period, were excluded from the planned efficacy, PK and safety analyses.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Heart Rate | predose, various timeframes up to 5 hours post last dose | Heart rate measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). |
| Primary | Change From Predose in Mean Heart Rate | predose, various timeframes up to 5 hours post last dose | Heart rate measured at various timepoints minus the heart rate at predose. |
| Primary | Mean Systolic Blood Pressure | predose, various timeframes up to 5 hours post last dose | Systolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). |
| Primary | Change From Predose in Mean Systolic Blood Pressure | predose, various timeframes up to 5 hours post last dose | Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose |
| Primary | Mean Diastolic Blood Pressure | predose, various timeframes up to 5 hours post last dose | Diastolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). |
| Primary | Change From Predose in Mean Diastolic Blood Pressure | predose, various timeframes up to 5 hours post last dose | Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure |
| Primary | Mean Serum Potassium Levels | Predose, 2 hours and 6 hours postdose 1 | |
| Primary | Change From Predose in Mean Serum Potassium | predose, 2 and 6 hours post dose | Change in mean serum potassium at the specified timepoint minus the predose value. |
| Primary | Mean Serum Glucose Values | Predose, 2 and 6 hours post dose 1 | |
| Primary | Change From Predose in Mean Serum Glucose | predose, 2 and 6 hours post dose | Change in mean serum glucose at the specified timepoint minus the predose value. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Heart Rate | predose, various timeframes up to 5 hours post last dose | Intent to treat population | beats per minute | MEAN |
| SECONDARY | Mean Forced Expiratory Volume in One Second(FEV1) | predose, various postdose times | Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses. | liters | MEAN |
| PRIMARY | Change From Predose in Mean Heart Rate | predose, various timeframes up to 5 hours post last dose | Intent to treat population | beats per minute | MEAN |
| PRIMARY | Mean Systolic Blood Pressure | predose, various timeframes up to 5 hours post last dose | Intent to treat population | mmHg | MEAN |
| PRIMARY | Change From Predose in Mean Systolic Blood Pressure | predose, various timeframes up to 5 hours post last dose | Intent to treat population | mmHg | MEAN |
| PRIMARY | Mean Diastolic Blood Pressure | predose, various timeframes up to 5 hours post last dose | Intent to treat population | mmHg | MEAN |
| PRIMARY | Change From Predose in Mean Diastolic Blood Pressure | predose, various timeframes up to 5 hours post last dose | Intent to treat population | mmHg | MEAN |
| PRIMARY | Mean Serum Potassium Levels | Predose, 2 hours and 6 hours postdose 1 | Intent to treat population | mEq/L | MEAN |
| PRIMARY | Change From Predose in Mean Serum Potassium | predose, 2 and 6 hours post dose | Intent to treat population | mEq/L | MEAN |
| PRIMARY | Mean Serum Glucose Values | Predose, 2 and 6 hours post dose 1 | Intent to treat population | mg/dl | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group456
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Heart Rate | Levalbuterol 0.63 mg | Predose (n=51,52,40) | 87.6 | Standard Deviation 12.56 | beats per minute |
| Mean Heart Rate | Arformoterol 7.5 Mcg | Predose (n=51,52,40) | 84.7 | Standard Deviation 14.11 | beats per minute |
| Mean Heart Rate | Arformoterol 15 Mcg | Predose (n=51,52,40) | 87.0 | Standard Deviation 17.47 | beats per minute |
| Mean Heart Rate | Levalbuterol 0.63 mg | 15 min post dose 1 (n=51,52,40) | 89.3 | Standard Deviation 15.57 | beats per minute |
| Mean Heart Rate | Arformoterol 7.5 Mcg | 15 min post dose 1 (n=51,52,40) | 85.2 | Standard Deviation 15.19 | beats per minute |
| Mean Heart Rate | Arformoterol 15 Mcg | 15 min post dose 1 (n=51,52,40) | 89.4 | Standard Deviation 16.88 | beats per minute |
| Mean Heart Rate | Levalbuterol 0.63 mg | 30 min post dose 1 (n=51,52,40) | 90.9 | Standard Deviation 14.47 | beats per minute |
| Mean Heart Rate | Arformoterol 7.5 Mcg | 30 min post dose 1 (n=51,52,40) | 86.6 | Standard Deviation 14.63 | beats per minute |
| Mean Heart Rate | Arformoterol 15 Mcg | 30 min post dose 1 (n=51,52,40) | 89.5 | Standard Deviation 15.59 | beats per minute |
| Mean Heart Rate | Levalbuterol 0.63 mg | 60 min post dose 1 (n=51,51,40) | 96.4 | Standard Deviation 12.33 | beats per minute |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cross-over Period | STARTED | ARF/LEV | 27 | |
| Cross-over Period | STARTED | LEV/ARF | 26 | |
| Cross-over Period | COMPLETED | ARF/LEV | 22 | |
| Cross-over Period | COMPLETED | LEV/ARF | 24 | |
| Cross-over Period | NOT COMPLETED | ARF/LEV | 5 | |
| Cross-over Period | NOT COMPLETED | LEV/ARF | 2 | |
| Washout | STARTED | ARF/LEV | 22 | |
| Washout | STARTED | LEV/ARF | 24 | |
| Washout | COMPLETED | ARF/LEV | 22 | |
| Washout | COMPLETED | LEV/ARF | 24 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events75
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 | Levalbuterol 0.63 mg | 0 | 51 | 0 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Arformoterol 7.5 Mcg | 1 | 52 | 1 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Arformoterol 15 Mcg | 1 | 40 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Levalbuterol 0.63 mg | 1 | 51 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Arformoterol 7.5 Mcg | 0 | 52 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Arformoterol 15 Mcg | 0 | 40 | 0 |
| other | Stomach Discomfort | Gastrointestinal disorders | Levalbuterol 0.63 mg | 1 | 51 | 1 |
| other | Stomach Discomfort | Gastrointestinal disorders | Arformoterol 7.5 Mcg | 0 | 52 | 0 |
| other | Stomach Discomfort | Gastrointestinal disorders | Arformoterol 15 Mcg | 0 | 40 | 0 |
| other | Toothache | Gastrointestinal disorders | Levalbuterol 0.63 mg | 0 | 51 | 0 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levalbuterol 0.63 mg | ||
| Total, all-cause mortality | Arformoterol 7.5 Mcg | ||
| Total, all-cause mortality | Arformoterol 15 Mcg | ||
| Total, other adverse events | Levalbuterol 0.63 mg | 10 | 51 |
| Total, other adverse events | Arformoterol 7.5 Mcg | 7 | 52 |
| Total, other adverse events | Arformoterol 15 Mcg | 8 | 40 |
| Total, serious adverse events | Levalbuterol 0.63 mg | 0 | 51 |
| Total, serious adverse events | Arformoterol 7.5 Mcg | 0 | 52 |
| Total, serious adverse events | Arformoterol 15 Mcg | 0 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21584948 | RESULT |
Source PubMed
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/NCT00583947
GET https://conductscience.org/api/trials/v1/NCT00583947/results?page=2