Effects of Anticholinergic or Long-Acting Beta 2 Agonist on FeNO and Pulmonary Function in SCI
Status unconfirmed · Phase 1
Conditions studied: Spinal Cord Injury
In brief
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
Key facts
- Study ID
- NCT01355991
- Run by
- James J. Peters Veterans Affairs Medical Center
- People needed
- 40
- Starts
- 2011-08-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2015-10-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Kessler Institute for Rehabilitation — West Orange, New Jersey, United States
- James J. Peters VA Medical Center — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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