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

NCT01355991 | Unknown Phase 1

• 1 other identifier: 01327
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; Tetraplegia; Pulmonary Function; Bronchodilator

Outcome Measures

Primary Outcomes (1)

• The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO)

  This will be a crossover trial. Baseline measurements will be taken, followed by two weeks of drug intervention (Salmeterol or Tiotropium Bromide). After two weeks the subject will return for post drug measurements. There will be a wash out period of four weeks, and then the subject will return again for the baseline measurements of drug 2, followed by two weeks of intervention and a final assessment.

  Approximately 8 weeks

Secondary Outcomes (2)

• Selected Biomarkers of inflammation(TNF-alpha,Isoprostane 8, Leukotriene B4) in exhaled breath condensates (EBC)after intervention

  Approx. 8 weeks

• Pulmonary function, as measured by pulmonary function tests and body plethysmography

  Approx. 8 weeks

Study Arms (2)

Anticholinergic Agent

ACTIVE COMPARATOR

Drug: Tiotropium

Long Acting Beta 2 Agonist

ACTIVE COMPARATOR

Drug: Salmeterol

Interventions

Tiotropium DRUG

18mcg/ capsule inhaled once daily for two weeks.

Anticholinergic Agent

Salmeterol DRUG

50mcg inhalation twice daily for two weeks

Long Acting Beta 2 Agonist

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead
• Kessler Institute for Rehabilitation: collaborator

Study Sites (2)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Interventions

Tiotropium Bromide; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Officials

• Miroslav Radulovic, MD

  James J. Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 19, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 23, 2015

Record last verified: 2015-10

Locations

US (2)