Long-Term Safety Performance of Fexofenadine in Asthma

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Fexofenadine; Montelukast; Terfenadine

Criteria

Inclusion criteria:

• Males and non-pregnant, non-breastfeeding females 12 through 80 years of age

• FEV1 in the context of this study is greater than 40% and not less or equal to 87% of predicted values for subjects not currently taking ICS and greater than 40% and not less or equal to 95% for those subjects taking ICS at Visit 1 and/or Visit 2 (and no albuterol use within 6 hours prior to spirometry)

• Improvement in FEV1 of at least 12% of predicted value and at least 200ml within 15 to 30 minutes of inhaling 2 puffs of albuterol 90mcg/actuation demonstrated at study entry OR documented during the previous 12 months at the study site.

• Use of a short-acting, beta-agonist inhaler to treat asthma symptoms on an average of at least 2 days per week during the previous 2 weeks (greater than or equal to 4 days total during the previous 2 weeks, excluding prophylactic use).

Exclusion criteria:

• Otherwise healthy