Long-Term Safety Performance of Fexofenadine in Asthma

Completed · Phase 3

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT00045955

Run by

Sanofi

People needed

1200

Starts

2002-02-01

Expected to finish

2003-11-01

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 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).

You may not qualify if…

• Otherwise healthy

Where it is running

• Aventis Pharmaceutical Inc. — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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