NCT01355991UnknownPhase 1
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
James J. Peters Veterans Affairs Medical Center2 sites in 1 country40 target enrollmentStarted: August 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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;
- •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.
Arms & Interventions
Anticholinergic Agent
Active Comparator
Intervention: Tiotropium (Drug)
Long Acting Beta 2 Agonist
Active Comparator
Intervention: Salmeterol (Drug)
Outcomes
Primary Outcomes
The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO)
Time Frame: Approximately 8 weeks
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.
Secondary Outcomes
- 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)
Investigators
Miroslav Radulovic, M.D.
Staff Physician
James J. Peters Veterans Affairs Medical Center
Study Sites (2)
Loading locations...
Similar Trials
Unknown
Not Applicable
Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive BladderOveractive BladderNCT01409512Rambam Health Care Campus30
Active, not recruiting
Phase 1
Impact of anticholinergic treatment on urinary discomfort during radiotherapy for prostate cancerSymptomatology related to acute urinary toxicity occuring during prostate irradiation in patients suffering from prostate cancer.MedDRA version: 18.1Level: HLTClassification code 10004995Term: Bladder and urethral symptomsSystem Organ Class: 100000004857EUCTR2014-004296-22-FRCentre Eugène Marquis
Completed
Not Applicable
A study of the effect of long-term anticholinergic administration -solifenacin succinateoveractive bladderJPRN-UMIN000017260Hokkaido University Graduate School of Medicine100
Unknown
Phase 4
Management of Chronic Pain in Military Patients With Injuries Sustained During Active DutyExtremity InjuryNCT01616342Sceptor Pain Foundation180
Completed
Phase 2
Effect of Long Acting Anticholinergic on Nocturnal Incontinence After Radical Cystectomy and Orthotopic NeobladderNocturnal IncontinenceNCT02877901Mansoura University120