Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma

Completed · Phase 3

Conditions studied: Asthma

In brief

The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma

Key facts

Study ID

NCT00044824

Run by

Sanofi

People needed

1000

Starts

2002-02-01

Expected to finish

2003-10-01

Last updated by the study team

2008-08-21

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and non-pregnant, non-breastfeeding females 12 through 80 years of age
• FEV1 in the context of this study is greater than 60% and not less or equal to 87% of predicted values at Visit 1 or Visit 2 (and no short-acting agent beta-agonist 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).

You may not qualify if…

• Otherwise healthy

Where it is running

• Aventis Pharmaceuticals Inc. — Bridgewater, New Jersey, United States
• Sanofi-Aventis Admnistrative Office — Costa Rica, Costa Rica
• Sanofi-Aventis Administrative Office — Guatemala City, Guatemala
• sanofi-aventis Hungaria — Budapest, Hungary
• Sanofi-Aventis Administrative Office — México, Mexico
• sanofi-aventis Poland — Warsaw, Poland
• Sanofi-Aventis Aministrative Office — Moscow, Russia

Full record on ClinicalTrials.gov

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