Trial · NCT01987219
The Effects Of Bronchodilator Therapy On Respiratory And Autonomic Function In Patients With Familial Dysautonomia
NCT01987219, Phase 3, Completed, NYU Langone Health; results first posted 2016-06-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects Of Bronchodilator Therapy On Respiratory And Autonomic Function In Patients With Familial Dysautonomia. Trials, record NCT01987219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01987219
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects Of Bronchodilator Therapy On Respiratory And Autonomic Function In Patients With Familial Dysautonomia
- NCT number
- NCT01987219
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 15 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Familial Dysautonomia
- Interventions
- Albuterol-sulphate, Ipratropium-bromide, placebo
- First posted
- 2013-11-19
- Last updated
- 2016-06-02
- Results first posted
- 2016-06-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline of Forced Vital Capacity | Pre and 30 minutes post study drug administration | FVC is a measure of the amount of air exhaled, and is measured in liters of air per second. The percentage in the change in the amount of air exhaled from baseline, measured in liters of air per second. Increase in the percentage of air exhaled from baseline indicates improvement in respiratory function. |
| Primary | Change in Respiratory Function (Airway Resistance at 5 Hz) From Baseline | Pre and 30 minutes post study drug administration | The percentage change in respiratory function from baseline is measured in percentage change in Resistance, kPa/(L/s). |
| Secondary | Change in Forced Expiratory Volume (FEV) From Baseline | Pre and 30 post study drug admistration | Forced expiratory volume is measured in liters of air per second. FEV was measured during the first second of exhalation. |
| Secondary | Change in Forced Expiratory Flow Between 25-75% (FEF25-75) | pre and 30 minutes post intervention | FEF25-75 is measured in liters of air per second at 25-75% |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline of Forced Vital Capacity | Pre and 30 minutes post study drug administration | Per protocol | percentage change from baseline | MEAN |
| PRIMARY | Change in Respiratory Function (Airway Resistance at 5 Hz) From Baseline | Pre and 30 minutes post study drug administration | percentage change from baseline | MEAN | |
| SECONDARY | Change in Forced Expiratory Volume (FEV) From Baseline | Pre and 30 post study drug admistration | percentage change from baseline | MEAN | |
| SECONDARY | Change in Forced Expiratory Flow Between 25-75% (FEF25-75) | pre and 30 minutes post intervention | percentage change from baseline | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline of Forced Vital Capacity | Albuterol-sulphate | 5.5 | Standard Deviation 13.6 | percentage change from baseline | |
| Change From Baseline of Forced Vital Capacity | Ipratropium-bromide (Atrovent ®) | 4.7 | Standard Deviation 10.9 | percentage change from baseline | |
| Change From Baseline of Forced Vital Capacity | Placebo | 0.9 | Standard Deviation 10.7 | percentage change from baseline | |
| Change in Respiratory Function (Airway Resistance at 5 Hz) From Baseline | Albuterol-sulphate | -22.7 | Standard Deviation 18.6 | percentage change from baseline | |
| Change in Respiratory Function (Airway Resistance at 5 Hz) From Baseline | Ipratropium-bromide (Atrovent ®) | -19.5 | Standard Deviation 15.5 | percentage change from baseline | |
| Change in Respiratory Function (Airway Resistance at 5 Hz) From Baseline | Placebo | -1.1 | Standard Deviation 12.5 | percentage change from baseline | |
| Change in Forced Expiratory Volume (FEV) From Baseline | Albuterol-sulphate | 7.69 | Standard Deviation 12.06 | percentage change from baseline | |
| Change in Forced Expiratory Volume (FEV) From Baseline | Ipratropium-bromide (Atrovent ®) | 4.81 | Standard Deviation 9.9 | percentage change from baseline | |
| Change in Forced Expiratory Volume (FEV) From Baseline | Placebo | -0.9 | Standard Deviation 7.6 | percentage change from baseline | |
| Change in Forced Expiratory Flow Between 25-75% (FEF25-75) | Albuterol-sulphate | 14.7 | Standard Deviation 30.6 | percentage change from baseline |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ipratropium; Alubterol; Placebo | 2 | |
| Overall Study | STARTED | Albuterol; Placebo; Ipratropium | 2 | |
| Overall Study | STARTED | Albuterol; Ipratropium; Placebo | 7 | |
| Overall Study | STARTED | Placebo; Ipratropium; Albuterol | 2 | |
| Overall Study | STARTED | Placebo; Albuterol; Ipratropium | 1 | |
| Overall Study | STARTED | Ipratropium; Placebo; Albuterol | 1 | |
| Overall Study | COMPLETED | Ipratropium; Alubterol; Placebo | 2 | |
| Overall Study | COMPLETED | Albuterol; Placebo; Ipratropium | 2 | |
| Overall Study | COMPLETED | Albuterol; Ipratropium; Placebo | 6 | |
| Overall Study | COMPLETED | Placebo; Ipratropium; Albuterol | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse 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 | Albuterol-sulphate | ||
| Total, all-cause mortality | Ipratropium-bromide (Atrovent ®) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Albuterol-sulphate | 0 | 0 |
| Total, other adverse events | Ipratropium-bromide (Atrovent ®) | 0 | 0 |
| Total, other adverse events | Placebo | 0 | 0 |
| Total, serious adverse events | Albuterol-sulphate | 0 | 0 |
| Total, serious adverse events | Ipratropium-bromide (Atrovent ®) | 0 | 0 |
| Total, serious adverse events | Placebo | 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/NCT01987219
GET https://conductscience.org/api/trials/v1/NCT01987219/registered