The Effects of Bronchodilator Therapy On Respiratory and Autonomic Function in Patients With Familial Dysautonomia
Sponsor study identifier
interventional
15
1 country
1
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Evaluate the effects of bronchodilator therapy on respiratory function. Our overall goal is to determine whether, in patients with familial dysautonomia (FD), there is a component of airway obstruction that is reversible. To this end, we will evaluate airway resistance before and after receiving the anti-cholinergic ipratropium (Atrovent ®) and the beta-2-agonist albuterol (ProVentil®/Ventolin®). We predict that the response to either drug will depend on the underlying level of sympathetic and parasympathetic activity and airway tone. We will then determine the cardiovascular effects of inhaled ipratropium and albuterol in patients with FD. Because patients with FD have fewer sympathetic neurons and denervation supersenstivity, we predict that following albuterol inhalation, there will be non-selective activation of alpha-1-adrenergic receptors. Furthermore, because of a congenital defect in the afferent baroreceptor neurons that sense blood pressure, we suspect that the resulting vasoconstriction will be unopposed leading to a pressor effect. We hypothesize that inhalation of the anti-cholinergic ipratopium will produce little rise in heart rate, due to the extent of parasympathetic denervation to the heart.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 5, 2013
Actual (reported)November 19, 2013
Actual (reported)December 2014
Actual (reported)December 2014
Actual (reported)June 2, 2016
Actual (reported)Change From Baseline of Forced Vital Capacity
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.
Pre and 30 minutes post study drug administration
Change in Respiratory Function (Airway Resistance at 5 Hz) From Baseline
The percentage change in respiratory function from baseline is measured in percentage change in Resistance, kPa/(L/s).
Pre and 30 minutes post study drug administration
Change in Forced Expiratory Volume (FEV) From Baseline
Pre and 30 post study drug admistration
Change in Forced Expiratory Flow Between 25-75% (FEF25-75)
pre and 30 minutes post intervention
Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 - 30 mins. Mean duration of effect 3 hours
IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 - 90 mins. Duration of effect 2 - 4 hours.pium-bromide
Placebo Saline solution 3 cc NA
Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 - 30 mins. Mean duration of effect 3 hours
Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 - 90 mins. Duration of effect 2 - 4 hours.
NYU Medical Center
New York, New York, 10016, United States
15 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2013
First Posted
November 19, 2013
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Saline solution 3 cc NA
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
June 2, 2016
Results First Posted
June 2, 2016
Record last verified: 2016-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: