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The Effects Of Bronchodilator Therapy On Respiratory And Autonomic Function In Patients With Familial Dysautonomia

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ClinicalTrials.gov Identifier: NCT01987219
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : June 2, 2016
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Familial Dysautonomia
Interventions Drug: Albuterol-sulphate
Drug: Ipratropium-bromide
Other: placebo
Enrollment 15
Recruitment Details Fifteen patients with Familial Dysautonomia were enrolled into the study between March 2013 and December 2015. The study was conducted at the NYU Dsyautonomia Center and Israeli FD center.
Pre-assignment Details  
Arm/Group Title Ipratropium; Alubterol; Placebo Albuterol; Placebo; Ipratropium Albuterol; Ipratropium; Placebo Placebo; Ipratropium; Albuterol Placebo; Albuterol; Ipratropium Ipratropium; Placebo; Albuterol
Hide Arm/Group Description Participants in this group received ipratropium followed by albuterol followed by placebo Participants in this group received albuterol followed by placebo followed by ipratropium Participants in this group received albuterol followed by ipratropium followed by placebo Participants in this group received placebo followed by ipratropium followed by albuterol Participants in this group received placebo followed by albuterol followed by ipratropium Participants in this group received ipratropium followed by placebo followed by albuterol
Period Title: Overall Study
Started 2 2 7 2 1 1
Completed 2 2 6 2 1 1
Not Completed 0 0 1 0 0 0
Arm/Group Title Ipratropium; Alubterol; Placebo Albuterol; Placebo; Ipratropium Albuterol; Ipratropium; Placebo Placebo; Ipratropium; Albuterol Placebo; Albuterol; Ipratropium Ipratropium; Placebo; Albuterol Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 2 2 7 2 1 1 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 7 participants 2 participants 1 participants 1 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
2
  28.6%
0
   0.0%
0
   0.0%
0
   0.0%
2
  13.3%
Between 18 and 65 years
2
 100.0%
2
 100.0%
5
  71.4%
2
 100.0%
1
 100.0%
1
 100.0%
13
  86.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 7 participants 2 participants 1 participants 1 participants 15 participants
Female
2
 100.0%
1
  50.0%
4
  57.1%
0
   0.0%
0
   0.0%
0
   0.0%
7
  46.7%
Male
0
   0.0%
1
  50.0%
3
  42.9%
2
 100.0%
1
 100.0%
1
 100.0%
8
  53.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White, not of Hispanic-American Origin Number Analyzed 2 participants 2 participants 7 participants 2 participants 1 participants 1 participants 15 participants
2 2 7 2 1 1 15
1.Primary Outcome
Title Change From Baseline of Forced Vital Capacity
Hide Description 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.
Time Frame Pre and 30 minutes post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Albuterol-sulphate Ipratropium-bromide (Atrovent ®) Placebo
Hide Arm/Group Description:

Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours

Albuterol-sulphate: 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

Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.

Placebo Saline solution 3 cc NA

placebo: Saline solution 3 cc NA

Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
5.5  (13.6) 4.7  (10.9) 0.9  (10.7)
2.Primary Outcome
Title Change in Respiratory Function (Airway Resistance at 5 Hz) From Baseline
Hide Description The percentage change in respiratory function from baseline is measured in percentage change in Resistance, kPa/(L/s).
Time Frame Pre and 30 minutes post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol-sulphate Ipratropium-bromide (Atrovent ®) Placebo
Hide Arm/Group Description:

Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours

Albuterol-sulphate: 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

Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.

Placebo Saline solution 3 cc NA

placebo: Saline solution 3 cc NA

Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
-22.7  (18.6) -19.5  (15.5) -1.1  (12.5)
3.Secondary Outcome
Title Change in Forced Expiratory Volume (FEV) From Baseline
Hide Description Forced expiratory volume is measured in liters of air per second. FEV was measured during the first second of exhalation.
Time Frame Pre and 30 post study drug admistration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol-sulphate Ipratropium-bromide (Atrovent ®) Placebo
Hide Arm/Group Description:

Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours

Albuterol-sulphate: 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

Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.

Placebo Saline solution 3 cc NA

placebo: Saline solution 3 cc NA

Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
7.69  (12.06) 4.81  (9.9) -0.9  (7.6)
4.Secondary Outcome
Title Change in Forced Expiratory Flow Between 25-75% (FEF25-75)
Hide Description FEF25-75 is measured in liters of air per second at 25-75%
Time Frame pre and 30 minutes post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol-sulphate Ipratropium-bromide (Atrovent ®) Placebo
Hide Arm/Group Description:

Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours

Albuterol-sulphate: 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

Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.

Placebo Saline solution 3 cc NA

placebo: Saline solution 3 cc NA

Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
14.7  (30.6) 11.5  (36.1) -2.99  (23.3)
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and Other [Not Including Serious] Adverse Events were not collected/assessed.
 
Arm/Group Title Albuterol-sulphate Ipratropium-bromide (Atrovent ®) Placebo
Hide Arm/Group Description

Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours

Albuterol-sulphate: 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

Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.

Placebo Saline solution 3 cc NA

placebo: Saline solution 3 cc NA

All-Cause Mortality
Albuterol-sulphate Ipratropium-bromide (Atrovent ®) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol-sulphate Ipratropium-bromide (Atrovent ®) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Albuterol-sulphate Ipratropium-bromide (Atrovent ®) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Horacio Kaufmann
Organization: NYU School of Medicine
Phone: 212 263 7225
EMail: horacio.kaufmann@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01987219     History of Changes
Other Study ID Numbers: 13-00004
First Submitted: November 5, 2013
First Posted: November 19, 2013
Results First Submitted: March 14, 2016
Results First Posted: June 2, 2016
Last Update Posted: June 2, 2016