Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma

Korábbi kezelés

• Systemic steroids within the 4 weeks prior to enrollment
• Non-steroidal anti-inflammatory drugs (NSAIDs) for arthritis
• Infection treated by antibiotics within the 4 weeks prior to enrollment
• Immunization within the 4 weeks prior to enrollment
• Illicit drug use within the past year
• Asthma exacerbation within the 4 weeks prior to enrollment (includes ER, urgent care, or hospital visits due to asthma resulting in an increase in asthma-related medications)
• Undergoing evaluation for sleep apnea, or plans to institute treatment for sleep apnea (patients on a stable treatment regimen for sleep apnea for the last 3 months prior to enrollment will be allowed to participate)
• Participation in another clinical study within 4 weeks prior to enrollment

Más betegség

• Current/active upper respiratory infection (URI) (if active URI, wait until asymptomatic for 1 week to enroll)

Laborértékek

• Other significant non-pulmonary co-morbidities such as: coronary artery disease, peripheral vascular disease, cerebrovascular disease, congestive heart failure with an ejection fraction \<50%, liver disease or elevated liver enzymes at baseline, malignancy (excluding non-melanoma skin cancers), AIDS, renal failure with serum creatinine \>3.0, or disorders requiring steroid treatment such as vasculitis, lupus, rheumatoid arthritis

Egyéb

• Pregnant or lactating women
• Cognitively impaired adults
• Current diagnosis of polyposis or sinusitis.
• Lung pathology other than asthma
• Clinically significant abnormalities present on screening 12-lead electrocardiogram
• Women of childbearing potential using oral contraceptives who are not willing to use a second method of contraception during the study
• Subject does not sign informed consent

• Signed consent form by the subject
• Male or female
• Between 18 and 65 years old and capability to comprehend this trial.
• Asthma diagnosed by a physician at least 1 year prior to study enrollment
• Poorly-controlled asthma at study enrollment. Poorly controlled asthma is defined as: chronic symptoms, episodic exacerbations, persistent and variable airways obstruction despite a continued requirement for short-acting beta 2-agonists despite the use of high doses of inhaled steroids.
• Nonsmokers (stopped smoking at least 1 year ago) and limited life-time history of smoking (less than a 3 pack year history).
• Body mass index 19-40
• On a stable dose of inhaled corticosteroid for at least 4 weeks prior to study entry or had to use a rescue dose during the last 4 weeks.
• FEV1 \>50% predicted