This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.

Condition	Intervention	Phase
Asthma	Drug: Albuterol	Phase III

Further study details as provided by IVAX Research:

Ages Eligible for Study:  4 Years   -   11 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening
• Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90%
• Ability to perform spirometry
• Demonstrate 12% airways reversibility

Exclusion Criteria:

• Require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids
• Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases

Please refer to this study by ClinicalTrials.gov identifier  NCT00308685

David C Atkinson, PhD      305-575-6278    david_atkinson@ivax.com
Edmundo G Stahl, MD      305-575-6090    edmundo_stahl@ivax.com

Arkansas
      Little Rock Allergy and Asthma, Little Rock,  Arkansas,  72205-4565,  United States; Recruiting
California
      Allergy & Asthma Associates of Santa Clara Valley Research Center, San Jose,  California,  95117,  United States; Recruiting
      Allergy & Asthma Specialist Medical Group, Huntington Beach,  California,  92647,  United States; Recruiting
Colorado
      Colorado Allergy and Asthma Centers, PC, Englewood,  Colorado,  80112,  United States; Recruiting
      Colorado Allergy and Asthma Centers, PC, Lakewood,  Colorado,  80401,  United States; Recruiting
      Colorado Allergy and Asthma Centers, PC, Denver,  Colorado,  80230,  United States; Recruiting
      William Storms Medical Research, Colorado Springs,  Colorado,  80907,  United States; Recruiting
Georgia
      Southern Allergy & Asthma, PC, Savannah,  Georgia,  31405,  United States; Recruiting
Illinois
      Sneeze, Wheeze & Itch Associates, Inc., Normal,  Illinois,  61761,  United States; Recruiting
Minnesota
      Clinical Research Institute, Minneapolis,  Minnesota,  55402,  United States; Recruiting
Nebraska
      The Asthma & Allergy Center, PC, Papillion,  Nebraska,  68046,  United States; Recruiting
Ohio
      Allergy and Respiratory Center, Canton,  Ohio,  44718,  United States; Recruiting
Oklahoma
      Allergy, Asthma & Clinical Research Center, Oklahoma City,  Oklahoma,  73120,  United States; Recruiting
Texas
      Pediatric Pulmonary Associates of North Texas, Dallas,  Texas,  75230,  United States; Recruiting

Study ID Numbers:  IXR-303-25-167
Last Updated:  September 21, 2006
Record first received:  March 28, 2006
ClinicalTrials.gov Identifier:  NCT00308685
Health Authority: United States: Food and Drug Administration

 

Asthma  (National Heart, Lung, and Blood Institute)

Asthma  (Nemours Foundation)

Asthma  (Nemours Foundation)

Asthma and Teens  (Nemours Foundation)

Asthma Glossary  (Cleveland Clinic Foundation)

How Can I Deal with My Asthma?  (Nemours Foundation)

Directory of Asthma Camps  (Consortium on Children's Asthma Camps)

Asthma  (Patient Education Institute)

Asthma Hotline  (Environmental Protection Agency)

Childhood Asthma Overview  (American Lung Association)

Childhood Asthma  (Asthma and Allergy Foundation of America)

Asthma and Allergy Foundation of America  (Asthma and Allergy Foundation of America)

ClinicalTrials.gov: Asthma  (National Institutes of Health)

Talking to Your Child about Their Asthma  (American Academy of Allergy, Asthma, and Immunology)

If I Have Asthma, Can I Keep My Pet?  (Nemours Foundation)

Asthma Flare-Ups  (American Academy of Family Physicians)

Wheezing and Asthma in Infants  (Nemours Foundation)

Smoking and Asthma  (Nemours Foundation)

Kids' Asthma Check: For Ages 1-8  (American College of Allergy, Asthma & Immunology)

EPA-Funded Study Finds Key Elements of Successful Asthma Programs  (Environmental Protection Agency)

Kids' Asthma Check: For Ages 8-14  (American College of Allergy, Asthma & Immunology)

Asthma and School: Take a Team Approach  (Mayo Foundation for Medical Education and Research)

Asthma Medications for Kids  (American Lung Association)

Recognizing an Asthma Attack  (American Academy of Pediatrics)

Asthma in Children: Creating an Asthma Action Plan  (Mayo Foundation for Medical Education and Research)