Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01353599
• Other study ID #: 01349
• Status: Active, not recruiting
• Phase: Phase 1
• First received: May 12, 2011
• Last updated: October 22, 2015
• Start date: August 2011

Study information

• Verified date: October 2015
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Individuals with chronic cervical SCI are known to have a restrictive ventilatory defect due to complete or partial loss of respiratory muscle innervation which is dependent upon the level and completeness of injury [2]. In addition, they share many aspects of obstructive airway physiology commonly associated with asthma. In asthma, physiological responses such as decrease in baseline airway caliber, bronchodilatation following inhalation of a beta-2-adrenergic agonist or anticholinergic agent, airway hyperreactivity, are all closely related to airway inflammation. The cause of such inflammation is unclear, and may be multi-factorial and attributable to: recurrent respiratory infections due to inability to effectively clear secretions, unopposed parasymphathetic innervation, and loss of functional sympathetic innervation to the airways. Therefore, the investigators propose to test for the possible involvement the above mechanisms by pharmacological intervention, and to study effects of such intervention on overall pulmonary function and indirect measures of pulmonary inflammation: levels of FeNO, exhaled breath condensate (EBC) inflammatory biomarker profile, pulmonary function tests, and cellular profile of the induced sputum.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 to 65 years old; and

• Stable, tetraplegia C3-C8 levels (duration of injury >1 year).

Exclusion Criteria:

• Smoking, active or history of smoking during the last six months

• Active respiratory disease(s), such as COPD, inflammatory lung disease, obstructive lung diseases, or acute respiratory infections

• No known history of asthma during lifetime or recent (within 3 months) respiratory infections;

• Ventilator dependence;

• Use of medications known to affect the respiratory system, such as nizoral;

• aldesleukin

• oral corticosteroids (e.g., prednisone, dexamethasone)

• natalizumab

• drugs affecting liver enzymes that remove mometasone from your body (such as azole antifungals including itraconazole, macrolide antibiotics including erythromycin, cimetidine, rifamycins including rifabutin, St. John's wort, certain anti-seizure medicines including carbamazepine)

• Use of medications known to alter airway caliber;

• Coronary heart and/or artery disease, as indicated in the patient medical record;

• Hypertension, baseline blood pressure = 140/90mHg;

• Adrenal insufficiency, as indicated in the patient medical record;

• Pregnancy;

• Lack of mental capacity to give informed consent;

• History of glaucoma;

• History of cataracts; and

• Persisting pressure ulcer, or a recently healed wound (e.g., =3 months since wound closure).

• History of a milk protein allergy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Mometasone furoate
220mcg once daily, for eight weeks

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center	Bronx	New York
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
James J. Peters Veterans Affairs Medical Center	Kessler Institute for Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function	The following measures of pulmonary function will be assessed (At baseline and eight weeks post intervention): Spirometry Body Plethysmography	1 Hour	No
Secondary	The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate	Biomarkers of inflammation will be assessed from measured exhaled breath condensates collected at baseline and 8 weeks post.	30 mins, baseline and 8 week post	No
Secondary	The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum	We will determine the effects of the inhaled corticosteroid on the cellular profile of sputum. Sputum will be collected and centrifuged, then viewed under a microscope for determination of cellular profile.	15 mins during, baseline and 8 week post	No