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

James J. Peters Veterans Affairs Medical Center

Status and phase: Unknown; Phase 1

Conditions: Spinal Cord Injury

Treatments: Drug: Salmeterol; Drug: Tiotropium

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT01355991

01327

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Anticholinergic Agent

Active Comparator group

Treatment:

Drug: Tiotropium

Long Acting Beta 2 Agonist

Active Comparator group

Treatment:

Drug: Salmeterol