Clinical trial NCT01355991: Effects of Anticholinergic or Long-Acting Beta 2 Agonist on FeNO and Pulmonary Function in SCI
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Tetraplegia
Pulmonary Function
Bronchodilator
Lead sponsor: James J. Peters Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Kessler Institute for Rehabilitation
First posted: 2011-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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


Eligibility 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.

Primary outcomes:
measure: The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO)
timeFrame: Approximately 8 weeks
Secondary outcomes:
measure: Selected Biomarkers of inflammation(TNF-alpha,Isoprostane 8, Leukotriene B4) in exhaled breath condensates (EBC)after intervention
timeFrame: Approx. 8 weeks
measure: Pulmonary function, as measured by pulmonary function tests and body plethysmography
timeFrame: Approx. 8 weeks
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
Study officials:
affiliation: James J. Peters VA Medical Center
name: Miroslav Radulovic, MD
role: PRINCIPAL_INVESTIGATOR
References: