Trial · NCT00819637
A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients
NCT00819637, Phase 4, Terminated, Henry Ford Health System; results first posted 2010-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients. Trials, record NCT00819637. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00819637
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients
- NCT number
- NCT00819637
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 2 participants, actual
- Lead sponsor
- Henry Ford Health System
- Conditions
- Acute Asthma
- Interventions
- arformoterol (RR formoterol), placebo, levalbuterol
- First posted
- 2009-01-09
- Last updated
- 2023-05-24
- Results first posted
- 2010-06-29
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Averaged Mean Percent Change From Baseline FEV1 and PEFR (Percent Predicted and Absolute) After the 3 Doses of Study Drug | 1 hour | |
| Secondary | Most Effective Dose of Inhalation Arformoterol for Treating Acute Bronchospasm in Asthmatics by Evaluating the Averaged Mean Percent Change From Baseline % Predicted FEV1 After 3 Doses of Study Medication in Each of the 3 Groups | 1 hour | The study was terminated early and therefore secondary outcome measures were not obtained. |
| Secondary | Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability. | 5 hours | The study was terminated early and therefore secondary outcome measures were not obtained. |
| Secondary | The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug | 1 hour | |
| Secondary | The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug | 1 hour | The study was terminated early and therefore secondary outcome measures were not obtained. |
| Secondary | The Peak Change (Liters) and Peak Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug | 1 hour | |
| Secondary | The Time to Onset of a 15% Improvement in FEV1 for Each Dose (Individual and Cumulative) and Total Dose of Study Medication to Reach This | 5 hour | |
| Secondary | The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative) | 5 hours | |
| Secondary | Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED) | 5 hours | The 2 subjects enrolled were both discharged home after study protocol completion, with no further treatment required in the ED setting. |
| Secondary | Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments | 5 hours | 2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Averaged Mean Percent Change From Baseline FEV1 and PEFR (Percent Predicted and Absolute) After the 3 Doses of Study Drug | 1 hour | Study was terminated after two patients enrolled. Data not collected. | ||
| SECONDARY | Most Effective Dose of Inhalation Arformoterol for Treating Acute Bronchospasm in Asthmatics by Evaluating the Averaged Mean Percent Change From Baseline % Predicted FEV1 After 3 Doses of Study Medication in Each of the 3 Groups | 1 hour | The study was terminated early and therefore outcome measures were not obtained. | ||
| SECONDARY | Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability. | 5 hours | The study was terminated early and therefore outcome measures were not obtained. | ||
| SECONDARY | The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug | 1 hour | The study was terminated early, therefore outcome measures were not obtained. | ||
| SECONDARY | The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug | 1 hour | The study was terminated early and therefore outcome measures were not obtained | ||
| SECONDARY | The Peak Change (Liters) and Peak Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug | 1 hour | The study was terminated early and therefore outcome measures were not obtained | ||
| SECONDARY | The Time to Onset of a 15% Improvement in FEV1 for Each Dose (Individual and Cumulative) and Total Dose of Study Medication to Reach This | 5 hour | The study was terminated early and therefore outcome measures were not obtained | ||
| SECONDARY | The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative) | 5 hours | The study was terminated early and therefore outcome measures were not obtained | ||
| SECONDARY | Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED) | 5 hours | The study was terminated early and therefore outcome measures were not obtained | ||
| SECONDARY | Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments | 5 hours | The study was terminated early and therefore outcome measures were not obtained. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arformoterol 1 Dose, Placebo 2 Doses | 2 | |
| Overall Study | STARTED | Arformoterol 3 Doses | 0 | |
| Overall Study | STARTED | Levalbuterol 3 Doses | 0 | |
| Overall Study | COMPLETED | Arformoterol 1 Dose, Placebo 2 Doses | 2 | |
| Overall Study | COMPLETED | Arformoterol 3 Doses | 0 | |
| Overall Study | COMPLETED | Levalbuterol 3 Doses | 0 | |
| Overall Study | NOT COMPLETED | Arformoterol 1 Dose, Placebo 2 Doses | 0 | |
| Overall Study | NOT COMPLETED | Arformoterol 3 Doses | 0 | |
| Overall Study | NOT COMPLETED | Levalbuterol 3 Doses | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arformoterol 1 Dose, Placebo 2 Doses | ||
| Total, all-cause mortality | Arformoterol 3 Doses | ||
| Total, all-cause mortality | Levalbuterol 3 Doses | ||
| Total, other adverse events | Arformoterol 1 Dose, Placebo 2 Doses | 0 | 2 |
| Total, other adverse events | Arformoterol 3 Doses | 0 | 0 |
| Total, other adverse events | Levalbuterol 3 Doses | 0 | 0 |
| Total, serious adverse events | Arformoterol 1 Dose, Placebo 2 Doses | 0 | 2 |
| Total, serious adverse events | Arformoterol 3 Doses | 0 | 0 |
| Total, serious adverse events | Levalbuterol 3 Doses | 0 | 0 |
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/NCT00819637
GET https://conductscience.org/api/trials/v1/NCT00819637/registered