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Effects of Anticholinergic or Long-Acting Beta 2 Agonist on FeNO and Pulmonary Function in SCI

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tiotropium
Salmeterol
Sponsored by
James J. Peters Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Tetraplegia, Pulmonary Function, Bronchodilator

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Chronic Spinal Cord Injury (>1 year post-injury)
  2. All American Spinal Injury Association (ASIA) classifications
  3. Stable tetraplegia (level of injury C3-C8, non-ventilator dependent)
  4. Age 18-65 years

Exclusion Criteria:

  1. Smoking, active or history of smoking within last 6 months;
  2. Active respiratory disease;
  3. Known history of asthma during lifetime or recent (within 3 months) respiratory infections;
  4. Use of medications known to affect the respiratory system;
  5. Use of medications known to alter airway caliber;
  6. Coronary heart and/or artery disease;
  7. Hypertension;
  8. Adrenal insufficiency;
  9. Pregnancy;
  10. Severe Milk Protein Allergy;
  11. Lack of mental capacity to give informed consent;
  12. Previous allergic reaction or hypersensitivity to salmeterol or tiotropium;
  13. Individuals taking medication(s) with known /potential drug interactions or suggested therapy modification for concomitant use with salmeterol or tiotropium such as:

(1) selective alpha-/beta- blockers: carvedilol, labetalol; (2) non-selective beta-blockers: Carteolol; Levobunolol; Metipranolol; Nadolol; Penbutolol; Pindolol; Propranolol; Sotalol; Timolol); (3) CYP3A4 Inhibitors: (e.g, Atazanavir; Clarithromycin; Conivaptan; Darunavir; Delavirdine; Fosamprenavir; Imatinib; Indinavir; Isoniazid; Itraconazole; Ketoconazole; Lopinavir; Nefazodone; Nelfinavir; NiCARdipine; Posaconazole; QuiNIDine; Ritonavir; Saquinavir; Telithromycin; Voriconazole; (4) Iobenguane I 123 / Sympathomimetics: Albuterol; Aminophylline; Arformoterol; Armodafinil; Benzphetamine; Caffeine; Dexmethylphenidate; Dextroamphetamine; Diethylpropion; Dipivefrin; DOBUTamine; DOPamine; Doxapram; Dyphylline; EPHEDrine; EPINEPHrine; Fenoterol; Formoterol; Isometheptene; Levalbuterol; Levonordefrin; Lisdexamfetamine; Metaproterenol; Methamphetamine; Methylphenidate; Midodrine; Modafinil; Naphazoline; Norepinephrine; Oxymetazoline; Phendimetrazine; Phentermine; Phenylephrine; Pirbuterol; Propylhexedrine; Pseudoephedrine; Sibutramine; Terbutaline; Theophylline; Xylometazoline.

Sites / Locations

  • Kessler Institute for Rehabilitation
  • James J. Peters VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Anticholinergic Agent

Long Acting Beta 2 Agonist

Arm Description

Outcomes

Primary Outcome Measures

The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO)
This will be a crossover trial. Baseline measurements will be taken, followed by two weeks of drug intervention (Salmeterol or Tiotropium Bromide). After two weeks the subject will return for post drug measurements. There will be a wash out period of four weeks, and then the subject will return again for the baseline measurements of drug 2, followed by two weeks of intervention and a final assessment.

Secondary Outcome Measures

Selected Biomarkers of inflammation(TNF-alpha,Isoprostane 8, Leukotriene B4) in exhaled breath condensates (EBC)after intervention
The subject will be randomized to receive either anticholinergic agent or long acting Beta2 agonist. Measurements of EBC will take place at baseline, 1 hr post drug administration, and two weeks after intervention. Biomarkers of inflammation will be assessed by collected exhaled breath condensates, which will subsequently be sent for biochemical analysis. Markers include Isoprostane-8, TNF-Alpha, and Leukotriene B4.
Pulmonary function, as measured by pulmonary function tests and body plethysmography
This will be a crossover trial. Baseline measurements will be taken, followed by two weeks of drug intervention (Salmeterol or Tiotropium Bromide). After two weeks the subject will return for post drug measurements. There will be a wash out period of four weeks, and then the subject will return again for the baseline measurements of drug 2, followed by two weeks of intervention and a final assessment. Pulmonary assessments include: Spirometry and Plethysmography.

Full Information

First Posted
May 12, 2011
Last Updated
October 22, 2015
Sponsor
James J. Peters Veterans Affairs Medical Center
Collaborators
Kessler Institute for Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT01355991
Brief Title
Effects of Anticholinergic or Long-Acting Beta 2 Agonist on FeNO and Pulmonary Function in SCI
Official Title
Acute and Chronic Effects of an Anticholinergic Agent or a Long-Acting Beta 2 Agonist on Levels of Exhaled Nitric Oxide and Pulmonary Function in Persons With Tetraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
James J. Peters Veterans Affairs Medical Center
Collaborators
Kessler Institute for Rehabilitation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the acute and chronic effects of a short course of treatment on spinal cord injured (SCI) individuals with either an anticholinergic agent (tiotropium) or with a β₂ agonist (Salmeterol) on: Fraction of expired NO (FeNO) Selected Biomarkers of inflammation in exhaled breath condensates (EBC) Pulmonary function, as measured by pulmonary function tests and body plethysmography

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury, Tetraplegia, Pulmonary Function, Bronchodilator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anticholinergic Agent
Arm Type
Active Comparator
Arm Title
Long Acting Beta 2 Agonist
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Description
18mcg/ capsule inhaled once daily for two weeks.
Intervention Type
Drug
Intervention Name(s)
Salmeterol
Intervention Description
50mcg inhalation twice daily for two weeks
Primary Outcome Measure Information:
Title
The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO)
Description
This will be a crossover trial. Baseline measurements will be taken, followed by two weeks of drug intervention (Salmeterol or Tiotropium Bromide). After two weeks the subject will return for post drug measurements. There will be a wash out period of four weeks, and then the subject will return again for the baseline measurements of drug 2, followed by two weeks of intervention and a final assessment.
Time Frame
Approximately 8 weeks
Secondary Outcome Measure Information:
Title
Selected Biomarkers of inflammation(TNF-alpha,Isoprostane 8, Leukotriene B4) in exhaled breath condensates (EBC)after intervention
Description
The subject will be randomized to receive either anticholinergic agent or long acting Beta2 agonist. Measurements of EBC will take place at baseline, 1 hr post drug administration, and two weeks after intervention. Biomarkers of inflammation will be assessed by collected exhaled breath condensates, which will subsequently be sent for biochemical analysis. Markers include Isoprostane-8, TNF-Alpha, and Leukotriene B4.
Time Frame
Approx. 8 weeks
Title
Pulmonary function, as measured by pulmonary function tests and body plethysmography
Description
This will be a crossover trial. Baseline measurements will be taken, followed by two weeks of drug intervention (Salmeterol or Tiotropium Bromide). After two weeks the subject will return for post drug measurements. There will be a wash out period of four weeks, and then the subject will return again for the baseline measurements of drug 2, followed by two weeks of intervention and a final assessment. Pulmonary assessments include: Spirometry and Plethysmography.
Time Frame
Approx. 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic Spinal Cord Injury (>1 year post-injury) All American Spinal Injury Association (ASIA) classifications Stable tetraplegia (level of injury C3-C8, non-ventilator dependent) Age 18-65 years Exclusion Criteria: Smoking, active or history of smoking within last 6 months; Active respiratory disease; Known history of asthma during lifetime or recent (within 3 months) respiratory infections; Use of medications known to affect the respiratory system; Use of medications known to alter airway caliber; Coronary heart and/or artery disease; Hypertension; Adrenal insufficiency; Pregnancy; Severe Milk Protein Allergy; Lack of mental capacity to give informed consent; Previous allergic reaction or hypersensitivity to salmeterol or tiotropium; Individuals taking medication(s) with known /potential drug interactions or suggested therapy modification for concomitant use with salmeterol or tiotropium such as: (1) selective alpha-/beta- blockers: carvedilol, labetalol; (2) non-selective beta-blockers: Carteolol; Levobunolol; Metipranolol; Nadolol; Penbutolol; Pindolol; Propranolol; Sotalol; Timolol); (3) CYP3A4 Inhibitors: (e.g, Atazanavir; Clarithromycin; Conivaptan; Darunavir; Delavirdine; Fosamprenavir; Imatinib; Indinavir; Isoniazid; Itraconazole; Ketoconazole; Lopinavir; Nefazodone; Nelfinavir; NiCARdipine; Posaconazole; QuiNIDine; Ritonavir; Saquinavir; Telithromycin; Voriconazole; (4) Iobenguane I 123 / Sympathomimetics: Albuterol; Aminophylline; Arformoterol; Armodafinil; Benzphetamine; Caffeine; Dexmethylphenidate; Dextroamphetamine; Diethylpropion; Dipivefrin; DOBUTamine; DOPamine; Doxapram; Dyphylline; EPHEDrine; EPINEPHrine; Fenoterol; Formoterol; Isometheptene; Levalbuterol; Levonordefrin; Lisdexamfetamine; Metaproterenol; Methamphetamine; Methylphenidate; Midodrine; Modafinil; Naphazoline; Norepinephrine; Oxymetazoline; Phendimetrazine; Phentermine; Phenylephrine; Pirbuterol; Propylhexedrine; Pseudoephedrine; Sibutramine; Terbutaline; Theophylline; Xylometazoline.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miroslav Radulovic, MD
Organizational Affiliation
James J. Peters VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Institute for Rehabilitation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
James J. Peters VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States

12. IPD Sharing Statement

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Effects of Anticholinergic or Long-Acting Beta 2 Agonist on FeNO and Pulmonary Function in SCI

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