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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by James J. Peters Veterans Affairs Medical Center
Sponsor:
Collaborator:
Kessler Institute for Rehabilitation
Information provided by (Responsible Party):
Miroslav Radulovic, M.D., James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01355991
First received: May 12, 2011
Last updated: March 30, 2015
Last verified: March 2015
  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: Tiotropium
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:


Further study details as provided by James J. Peters Veterans Affairs 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: 40
Study Start Date: August 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anticholinergic Agent Drug: Tiotropium
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)
  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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Miroslav Radulovic, MD 718-584-9000 ext 5472 miroslav.radulovic@va.gov
Contact: Joshua Hobson, MS 718-584-9000 ext 3129 joshua.hobson@va.gov

Locations
United States, New Jersey
Kessler Institute for Rehabilitation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Christopher Cirnigliaro, MS    973-731-3900 ext 2755    christopher.cirnigliaro@va.gov   
Contact: Frank Azarelo, MS    973-731-3900 ext 2755    frank.azarelo@va.gov   
United States, New York
James J. Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Miroslav Radulovic, MD    718-584-9000 ext 5472    miroslav.radulovic@va.gov   
Contact: Joshua Hobson, MS    718-584-9000 ext 3129    joshua.hobson@va.gov   
Principal Investigator: Miroslav Radulovic, MD         
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Kessler Institute for Rehabilitation
Investigators
Principal Investigator: Miroslav Radulovic, MD James J. Peters VA Medical Center
  More Information

No publications provided

Responsible Party: Miroslav Radulovic, M.D., Staff Physician, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01355991     History of Changes
Other Study ID Numbers: 01327
Study First Received: May 12, 2011
Last Updated: March 30, 2015
Health Authority: United States: Federal Government

Keywords provided by James J. Peters Veterans Affairs Medical Center:
Spinal Cord Injury
Tetraplegia
Pulmonary Function
Bronchodilator

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Cholinergic Antagonists
Cholinergic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2015