Overview

This trial is active, not recruiting.

Condition spinal cord injury
Treatments tiotropium, salmeterol
Phase phase 1
Sponsor James J. Peters Veterans Affairs Medical Center
Collaborator Kessler Institute for Rehabilitation
Start date August 2011
End date March 2016
Trial size 40 participants
Trial identifier NCT01355991, 01327

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
tiotropium
18mcg/ capsule inhaled once daily for two weeks.
(Active Comparator)
salmeterol
50mcg inhalation twice daily for two weeks

Primary Outcomes

Measure
The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO)
time frame: Approximately 8 weeks

Secondary Outcomes

Measure
Selected Biomarkers of inflammation(TNF-alpha,Isoprostane 8, Leukotriene B4) in exhaled breath condensates (EBC)after intervention
time frame: Approx. 8 weeks
Pulmonary function, as measured by pulmonary function tests and body plethysmography
time frame: Approx. 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

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
Principal investigator Miroslav Radulovic, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by James J. Peters Veterans Affairs Medical Center.