Trial Information

Summary: 12 WEEKS TREATMENT WITH 250 MICROGRAMS ROFLUMILAST VERSUS PLACEBO IN PATIENTS WITH ASTHMA

A multicenter clinical trial to evaluate the safety and effectiveness of an investigational asthma medication in adults with mild to moderate asthma. In this study some subjects will receive medication and others will recieve a placebo (sugar pill) but neither the subject nor the study personnel (ie doctor or research assistants) will know what they were on until the end of the study. This study will compare effects of roflumilast vs placebo on lung function, quality of life (if subject is able to do more activities that s/he was not able to do because of the asthma), symptoms (having trouble breathing, becoming short of breath, attacks, etc), and rescue medication use (how often subject uses his/her inhaler).
Compensation Provided

Patient Inclusion/Exclusion Criteria:

Written informed consent of subject that s/he understands and would like to participate in this study

History of mild to moderate asthma

Age 18-70
Asthma inhaled medication dosage of 420ug/day or less of Beclomethasone

No change in asthma treatment during the 4 weeks before enrolling in the study

In good mental health

Except for asthma, in good physical health

Non smoker or ex-smoker (1+ years since s/he quit)

Poorly controlled asthma

Asthma attacks or common cold/flu four weeks before enrolling in the study

Diagnosed with Chronic Obstructive Pulmonary Disease (COPD)

Abnormal results from blood tests done at first study appointment after informed consent

Use of oral steroid medication in the 4 weeks before starting the study

Use of inhaled steroid medication with a dose of greater than 420ug/day of Beclomethasone DP

Pregnancy, breast feeding or do not use birth control and is sexually active

Participation in another study within 30 days before first study visit

Current smoker or recent ex-smoker

Use of rescue medication (inhaler) of more than 8 puffs per day

Suspected sensitivity to the study medication

Use of seasonal allergy medications

If you would like to learn more about participating in this study, please send an e-mail message using the form below.