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

NCT ID: NCT01353599

Last Updated: 2015-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31

Brief 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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Asmanex

Study participants will receive inhaled Mometasone Furoate (Asmanex) 220mcg once daily for 8 weeks.

Group Type: EXPERIMENTAL

Mometasone furoate

Intervention Type: DRUG

220mcg once daily, for eight weeks

Interventions

Mometasone furoate

220mcg once daily, for eight weeks

Intervention Type: DRUG

Other Intervention Names

Asmanex

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Institute for Rehabilitation

INDUSTRY

Sponsor Role: collaborator

James J. Peters Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Miroslav Radulovic, M.D.

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miroslav Radulovic, MD

Role: PRINCIPAL_INVESTIGATOR

James J. Peters VA Medical Center

Locations

Kessler Institute for Rehabilitation

West Orange, New Jersey, United States

James J. Peters VA Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

01349

Identifier Type: -

Identifier Source: org_study_id