Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant or lactating women
Cognitively impaired adults
Systemic steroids within the 4 weeks prior to enrollment
Non-steroidal anti-inflammatory drugs (NSAIDs) for arthritis
Current diagnosis of polyposis or sinusitis.
Infection treated by antibiotics within the 4 weeks prior to enrollment
Immunization within the 4 weeks prior to enrollment
Lung pathology other than asthma
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
Illicit drug use within the past year
Current/active upper respiratory infection (URI) (if active URI, wait until asymptomatic for 1 week to enroll)
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)
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
Participation in another clinical study within 4 weeks prior to enrollment
Subject does not sign informed consent