The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics.

Condition	Treatment or Intervention	Phase
Asthma	Drug: Beclomethasone dipropionate HFA	Phase IV

Ages Eligible for Study:  12 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Poorly controlled asthma;
• Average use of over 2 puffs of albuterol per day in the previous 7 days OR Having symptoms of asthma on 5 of the last 7 days OR Awakening at night due to asthma at least once in the previous 7 days OR Having been treated with a course of oral or intravenous steroids at least once in the last 3 months.

Exclusion Criteria:

• Subjects receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for rhinitis;
• Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, oral or intranasal anticholinergics;
• History and/or presence of any non-asthmatic acute or chronic lung disease, including but not limited to bronchitis, emphysema, active tuberculosis, bronchiectasis or cystic fibrosis;
• History and/or presence of any clinically significant cardiovascular disease, clinically significant hepatic, renal, or endocrine dysfunction, stroke, uncontrolled diabetes, hyperthyroidism, convulsive disorders, neoplastic diseaseother than basal cell carcinoma, and significant psychiatric disease.

Colorado
      National Jewish Medical and Research Center, Denver,  Colorado,  United States

Study ID Numbers:  IXR-402-4-196
Record last reviewed:  October 2003
Record first received:  October 28, 2003
ClinicalTrials.gov Identifier:  NCT00071552
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10