Overview

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

Status:
Unknown status

Trial end date:
2016-08-01

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

James J. Peters Veterans Affairs Medical Center

Collaborator:

Kessler Institute for Rehabilitation

Treatments:

Cholinergic Antagonists
Salmeterol Xinafoate
Tiotropium Bromide

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.