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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anticholinergic Agent

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

18mcg/ capsule inhaled once daily for two weeks.

Long Acting Beta 2 Agonist

Group Type ACTIVE_COMPARATOR

Salmeterol

Intervention Type DRUG

50mcg inhalation twice daily for two weeks

Interventions

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Tiotropium

18mcg/ capsule inhaled once daily for two weeks.

Intervention Type DRUG

Salmeterol

50mcg inhalation twice daily for two weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No