Text Size

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

This study is not yet open for participant recruitment.
Verified May 2011 by Bronx VA Medical Center
Sponsor:
Information provided by:
Bronx VA Medical Center
ClinicalTrials.gov Identifier:
NCT01355991
First received: May 12, 2011
Last updated: May 17, 2011
Last verified: May 2011
History of Changes
  Purpose

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

Condition Intervention Phase
Spinal Cord Injury
 Drug: Salmeterol
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bronx VA Medical Center:

Primary Outcome Measures:
  • The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO) [ Time Frame: Approximately 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Approx. 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Approx. 8 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anticholinergic Agent Drug: Salmeterol
18mcg/ capsule inhaled once daily for two weeks.
Active Comparator: Long Acting Beta 2 Agonist Drug: Salmeterol
50mcg inhalation twice daily for two weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

Exclusion Criteria:

  1. Smoking, active or history of smoking during life time;
  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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355991

Contacts
Contact: Christopher Renzi, MA 7185849000 ext 3128 christopher.renzi@va.gov

Locations
United States, New York
James J. Peters VA Medical Center Not yet recruiting
Bronx, New York, United States, 10468
Contact: Christopher P Renzi, MA     718-584-9000 ext 3128     christopher.renzi@va.gov    
Principal Investigator: Miroslav Radulovic, MD            
Sub-Investigator: Gregory Schilero, MD            
Sub-Investigator: Munish Luthra, MD            
Sub-Investigator: William Bauman, MD            
Sub-Investigator: Christopher Cardozo, MD            
Sub-Investigator: Ann Spungen, EdD            
Sub-Investigator: Jill M Wecht, EdD            
Sub-Investigator: Michael LaFountaine, EdD            
Sponsors and Collaborators
Bronx VA Medical Center
Investigators
Principal Investigator: Miroslav Radulovic, MD James J. Peters VA Medical Center
  More Information

No publications provided

Responsible Party: Miroslav Radulovic, James J. Peters Dept of Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01355991     History of Changes
Other Study ID Numbers: 01327
Study First Received: May 12, 2011
Last Updated: May 17, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Quadriplegia
Spinal Cord Injuries
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Nitric Oxide
Salmeterol
Cholinergic Antagonists
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents
Adrenergic beta-2 Receptor Agonists

ClinicalTrials.gov processed this record on May 16, 2013