Trial Information

Summary: A study to assess the efficacy and safety of an investigational drug in children 6-23 months old with symptoms of asthma or reactive airways disease.

The purpose of this study is to assess the efficacy and safety of an investigational medication for asthma using an inhaler/spacer combination. The study drug is currently approved in the US for use by patients 12 years and older. After a 1-4 week screening period, qualified participants will be assigned to study treatment or placebo for 4 weeks. All study participants are also given a "quick-relief" medication, such as albuterol nebules, or another inhaler to be used in case of an asthma attack. Caregivers and their children will need to attend up to 6 outpatient study visits at the clinic and be available for telephone follow-up calls.

Children may be eligible if they:

• are 6 to 23 months old as of the 2nd study visit.
• have a history of asthma symptoms or reactive airways disease that has required medical attention within the last 3 months. These symptoms include wheezing, coughing, difficulty breathing, or chest tightness.
• are using doctor prescribed medicine(s) for the last 3 weeks or longer to treat asthma symptoms.

Patients are not eligible if they:

• have used systemic steroids as either liquids, pills or injection to treat asthma in the last 3 months. Examples of these medicines include prednisolone (Orapred, Pediapred, Prelone) and dexamethasone (Decadron, Dexone)
• have been admitted to a hospital intensive care unit within the last 6 months due to asthma symptoms or treated in an emergency room more than twice in the last 3 months because of asthma.
• have any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician. (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.)

Other medical criteria will be evaluated at the screening visit.

Healthy Volunteers: no
Gender: Both
Minimum Age: 6 Months
Maximum Age: 23 Months

Click Here to find out if you might qualify or visit www.findclinicalstudy.com for more information.

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Trial listings updated: June 1, 2008 at 5:43:55 AM